estradiol - Generic Medications
Browse 129 brand name versions of estradiol. Review brand names, dosage forms, strengths, and linked product records.
Climara (estradiol transdermal system), is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm 2 ) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15, 18.75 or 25 cm 2 , and contains 2, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The Climara transdermal system comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1. A translucent polyethylene film. 2. An acrylate adhesive matrix containing estradiol USP. 3. A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive. Chemical Structure Patch Diagram
Divigel (estradiol gel) 0.1 percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Divigel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: Divigel Chemical Structure The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive. Divigel Chemical Structure
DOTTI (estradiol transdermal system, USP) contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of DOTTI are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 g/mol. DOTTI is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP. 1 2
DOTTI (estradiol transdermal system, USP) contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of DOTTI are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 g/mol. DOTTI is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.
DOTTI (estradiol transdermal system, USP) contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of DOTTI are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 g/mol. DOTTI is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.
DOTTI (estradiol transdermal system, USP) contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of DOTTI are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 g/mol. DOTTI is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.
DOTTI (estradiol transdermal system, USP) contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of DOTTI are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 g/mol. DOTTI is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.
DOTTI (estradiol transdermal system, USP) contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of DOTTI are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 g/mol. DOTTI is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.
ELESTRIN (estradiol gel) contains 0.06% of estradiol, in a colorless, non-staining hydroalcoholic gel base. One pump actuation delivers ELESTRIN in a unit dose of 0.52 mg of estradiol in 0.87 g of gel. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17-diol, (17β)-. It has a molecular formula of C 18 H 24 O 2 •½H 2 O and molecular weight of 281.4. The structural formula is: The active component of ELESTRIN is estradiol. The remaining components of the gel (ethanol, propylene glycol, diethylene glycol monoethyl ether, carbomer homopolymer type C, triethanolamine, edetate disodium, and purified water) are pharmacologically inactive. Elestrin Structural Formula
Each gram of ESTRACE (estradiol vaginal cream USP 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary -butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.37. The structural formula is: The structural formula for ESTRACE (estradiol vaginal cream, USP, 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.37.
Each gram of ESTRACE (estradiol vaginal cream USP 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary -butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.37. The structural formula is: The structural formula for ESTRACE (estradiol vaginal cream, USP, 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.37.
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure
Estradiol Gel, 0.1% is a clear, colorless smooth gel, free from visible particulate matter. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol, an estrogen. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: The remaining components of the gel (carbomer, alcohol [62%], propylene glycol, purified water, and trolamine) are pharmacologically inactive. structure
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Estradiol transdermal system, USP is designed to provide nominal in vivo delivery of 0.014 mg of estradiol per day continuously upon application to intact skin. The period of use is 7 days. The transdermal system has a contact surface area of 3.9 cm 2 , and contains 0.982 mg of estradiol USP. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The estradiol transdermal system, USP comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1. a translucent polyethylene film. 2. an acrylate adhesive matrix containing estradiol USP. 3. A protective liner of silicon coated polyester film is attached to the adhesive surface and must be removed before the transdermal system can be used. Cross Section of the System: Estradiol transdermal system, USP is packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use. The active component of the transdermal system is estradiol USP. The remaining components of the transdermal system (acrylic adhesive, colloidal silicon dioxide, ethyl oleate, glyceryl monolaurate, isopropyl myristate, povidone, and polyethylene backing) are pharmacologically inactive. FDA approved drug release test specifications differ from USP. Estradiol Transdermal System, 14 mcg/day Estradiol Transdermal System, 14 mcg/ day
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure
Each gram of estradiol vaginal cream USP 0.01% contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and t e rtiar y -butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.37. The structural formula is: The structural formula is: Each gram of estradiol vaginal cream USP 0.01% contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.37.
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure
Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Structure formula.jpg
Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake.
Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm 2 ) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm 2 , and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. It has a molecular formula of C 18 H 24 O 2 • ½ H 2 O and molecular weight of 281.39. The structural formula is: Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: (1) A foam backing with adhesive layer (2) A polyester film (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive. Estradiol Structural Formula Transdermal Parts
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure
Estradiol Transdermal System, USP is designed to release estradiol continuously upon application to intact skin. Six (7.5, 11.25, 15, 18, 22.5 and 30 cm 2 ) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.5, 11.25, 15, 18, 22.5 or 30 cm 2 , and contains 1.888, 2.832, 3.777, 4.532, 5.665 or 7.553 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white or creamy white, small crystals or crystalline powder, odorless, stable in air and hygroscopic. Estradiol USP is chemically described as estra-1,3,5(10)-triene-3, 17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The Estradiol Transdermal System, USP comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: A translucent polyethylene film. An acrylate adhesive matrix containing estradiol USP. A protective liner of silicone coated polyester film is attached to the adhesive surface and must be removed before the system can be used. Cross Section of the System Estradiol Transdermal System, USP is packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use. The active component of the system is estradiol USP. The remaining components of the system (acrylic adhesive, colloidal silicon dioxide, ethyl oleate, glyceryl monolaurate, isopropyl myristate, povidone and polyethylene backing) are pharmacologically inactive. FDA approved drug release test specifications differ from USP. Estradiol Transdermal System Estradiol Transdermal System
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP.
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6. formula 3 layers
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP.
Estradiol vaginal inserts USP, 10 mcg, are small, white, film-coated inserts containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol, USP. Each insert of estradiol vaginal insert USP, 10 mcg contains the following excipients: corn starch, hypromellose, lactose monohydrate and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each estradiol vaginal insert, USP is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts, USP are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol, USP is released into the vagina. Estradiol hemihydrate is a white, almost white or colorless crystalline solid, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C 18 H 24 O 2 • ½ H 2 O with a molecular weight of 281.4. The structural formula is: 9ec90e26-figure-01
Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm 2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is: The molecular formula of estradiol is C 18 H 24 0 2. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. ----- (1) Backing ----- (2) Adhesive Containing Estradiol ----- (3) Protective Liner The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. Estradiol structural formula Estradiol Transdermal System - Layers
Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol gel 0.1 percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive. Estradiol Gel Structural Formula
Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Each gram of estradiol vaginal cream, USP, 0.01% contains 0.1 mg estradiol (as estradiol hemihydrate) in a nonliquefying base containing propylene glycol, methylparaben, sodium lauryl sulfate, mono- and di-glycerides, stearyl alcohol, ceresin wax, tert-butylhydroquinone, disodium EDTA, hypromellose, and purified water. Estradiol hemihydrate is chemically described as estra-1,3,5(10)-triene-3,17β-diol hemihydrate. It has an empirical formula of C 18 H 24 O 2 . ½H 2 O and molecular weight of 272.37. The structural formula is: structure
Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol gel 0.1 percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: The remaining components of the gel (carbomer, ethanol (62.03% v/v), propylene glycol, purified water, and triethanolamine) are pharmacologically inactive.
Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: In addition, each tablet for oral administration contains the following inactive ingredients: Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. structural-formula
Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Structure formula.jpg
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: [structure] C18H24O2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP.
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Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula
Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Structure formula.jpg
Estradiol Gel, 0.1% is a clear, colorless smooth gel, free from visible particulate matter. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: The remaining components of the gel (carbomer, alcohol [62%], propylene glycol, purified water, and trolamine) are pharmacologically inactive. estradiol-structure
Estradiol tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Structure formula.jpg
Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white to practically white powder, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure
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