SPL Set ID: a50e953d-447b-4b66-b567-04586174d3f9

1 drug(s) with this SPL Set ID

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DOXYCYCLINE DOXYCYCLINE
40 mg Capsule
ALEMBIC PHARMACEUTICALS INC. FDA Rx Only

Doxycycline capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline pellets (24 mg immediate release and 16 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22 H 24 N 2 O 8 ). The structural formula of doxycycline, USP is: with an empirical formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water and in alcohol, practically insoluble in ether. It dissolves in dilute solutions of mineral acids and in solutions of alkali hydroxides and carbonates. Inert ingredients in the formulation are: FD&C Red No. 40 Aluminum Lake, hypromellose, methacrylic acid copolymer, polysorbate 80, sugar spheres (composed of corn starch, purified water and sucrose), talc, and triethyl citrate. Hard gelatin capsule shell contains gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide. The capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac. FDA approved dissolution test method and specifications differ from USP. doxycycline-str.jpg

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