jubilant draximage inc., dba jubilant radiopharma - Medication Listings

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Drax Exametazime KIT FOR THE PREPARATION OF TECHNETIUM TC 99M EXAMETAZIME FOR LEUKOCYTE LABELING
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

11.1 Chemical Characteristics Drax Exametazime (kit for the preparation of technetium Tc 99m exametazime for leukocyte labeling) prepares a radioactive diagnostic agent. Each single-dose vial contains a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. The chemical formula of exametazime is C 13 H 28 N 4 O 2 , with the following structural formula: Prior to publication of the USAN, exametazime [also known as (RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime] was known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. When Tc 99m pertechnetate in Sodium Chloride Injection, USP (0.9%) is added to Drax Exametazime vial, a Tc 99m complex of exametazime is formed. chemical formula 11.2 Physical Characteristics Tc 99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 2. Table 2 Principal Radiation Emission Data - Tc 99m Radiation Mean %/Disintegration Mean Energy (keV) Gamma 2 88.5 140.5 11.3 External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc 99m is 5.23 m 2 ·pGy·(MBq) -1 ·s -1 [0.795 cm 2 ·R·(mCi) -1 ·h -1 ]. The first half-value thickness of lead (Pb) for Tc 99m is 0.25 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 3. For example, the use of a 3 mm thickness of Pb will decrease the external radiation exposure by a factor of approximately 1,000. Table 3 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 5 10 -5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 4. Table 4 Physical Decay Chart - Tc 99m half-life 6 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1.00 7 0.45 1 0.89 8 0.4 2 0.79 9 0.35 3 0.71 10 0.32 4 0.63 11 0.28 5 0.56 12 0.25 6 0.50 24 0.063

DRAXIMAGE DTPA KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

11.1 Chemical Characteristics DRAXIMAGE ® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. No bacteriostatic preservative is present. Its chemical name is: Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is: The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5. structure 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 7 . Table 7 Principal Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Gamma-2 88.5 140.5 The air-kerma-rate (exposure-rate) constant for Technetium Tc 99m is 5.23 m 2 ·pGy·(MBq) − 1 ·s − 1 [0.795 cm 2 ·R·(mCi) − 1 ·h − 1 ]. A range of values for the relative radiation attenuation by the various thicknesses of lead is shown in Table 8 . For example, the use of a 3 mm thickness of lead will attenuate the radiation emitted by a factor of about 1,000. Table 8 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 9 . Table 9 Physical Decay Chart of Technetium 99m Tc, Half Life: 6 Hours *Calibration Time Hours Fraction Remaining Hours Fraction Remaining 0 * 1.000 5 0.562 1 0.891 6 0.501 2 0.794 8 0.398 3 0.708 10 0.316 4 0.631 12 0.251

Fludeoxyglucose F 18 FLUDEOXYGLUCOSE F 18
30 ml Injection
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

11.1 Chemical Characteristics Fludeoxyglucose F 18 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18 F]fluoro-D-glucose has the molecular formula of C 6 H 11 18 FO 5 with a molecular weight of 181.26, and has the following chemical structure: Fludeoxyglucose F 18 Injection, USP is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20.0 to 300 mCi) of 2-deoxy-2-[ 18 F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative. image description 11.2 Physical Characteristics Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons that are produced and emitted simultaneously in opposite directions when the positron interacts with an electron (Table 2). Table 2. Principal Radiation Emission Data for Fluorine F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±)* 193.46 511.0 keV *Produced by positron annihilation From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981). The specific gamma ray constant (point source air kerma coefficient) for fluorine F 18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%. Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding Shield thickness (Pb) mm Coefficient of attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4. Table 4. Physical Decay Chart for Fluorine F 18 Minutes Fraction Remaining 0* 1.000 15 0.909 30 0.826 60 0.683 110 0.500 220 0.250 *Calibration time

HICON SODIUM IODIDE I 131
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

11.1 Chemical Characteristics HICON ® , a radioactive therapeutic agent, provides a concentrated solution of sodium iodide I 131 with a radioconcentration of 37,000 MBq/mL (1,000 mCi/mL). Each mL of the concentrated solution contains 37,000 MBq (1,000 mCi) of no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. The pH of the concentrated solution is between 7.5 and 10. The concentrated solution provided with HICON ® is used for the preparation of sodium iodide I 131 capsules or sodium iodide I 131 solution of varying strengths for oral administration for therapy. Sodium iodide I 131 solution is designated chemically as Na 131 I and has a molecular weight of 153.99 g/mol. Hard gelatin capsules, provided for the preparation of the sodium iodide I 131 capsules final dosage form, contain approximately 300 mg of dibasic sodium phosphate anhydrous USP as the absorbing buffer. 11.2 Physical Characteristics Iodide I 131 decays by beta emission and associated gamma emission with a physical half-life of 8.02 days. The principal radiation emissions are listed in Table 5. Table 5 Principal Radiation Emission Data from Decay of Sodium Iodide I 131 Radiation Mean % per Disintegration Mean Energy (keV) Beta-1 2.1% 69.4 Beta-3 7.2% 96.6 Beta-4 89.4% 191.6 Gamma-7 6.1% 284.3 Gamma-14 81.2% 364.5 Gamma-18 7.1% 637.0 11.3 External Radiation The specific gamma-ray constant for iodide I 131 is 4.26 × 10 -13 C•m 2 •kg -1 •MBq -1 •s -1 (2.2 R•cm 2 /mCi•hr). The first half-value thickness of lead (Pb) for iodide I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodide I 131 that results from interposition of various thicknesses of Pb is shown in Table 6. For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 100. Table 6 Radiation Attenuation of Iodine I 131 by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.27 0.5 0.56 0.25 0.99 10 -1 2.59 10 -2 4.53 10 -3 To correct for physical decay of iodine I 131, the fractions that remain at selected intervals after the time of calibration are shown in Table 7. Table 7 Physical Decay Chart: Iodine I-131 Half-Life 8.02 Days Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining 0 Calibration time 1.000 11 0.388 22 0.151 1 0.918 12 0.356 23 0.138 2 0.842 13 0.327 24 0.127 3 0.773 14 0.300 25 0.116 4 0.709 15 0.275 26 0.107 5 0.651 16 0.253 27 0.098 6 0.597 17 0.232 28 0.090 7 0.548 18 0.213 29 0.083 8 0.503 19 0.195 30 0.076 9 0.461 20 0.179 10 0.423 21 0.164

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid TECHNETIUM TC 99M SULFUR COLLOID KIT
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a Multi-Dose Reaction Vial, a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by subcutaneous, intraperitoneal, or intravenous injection or by oral administration. Each 10 mL Multi-Dose Reaction Vial contains, in lyophilized form 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; a Solution A vial contains 1.8 mL of 0.148 N hydrochloric acid solution and a Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. When a solution of sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection in isotonic saline is mixed with these components, following the instructions provided with the kit, Technetium Tc 99m Sulfur Colloid Injection is formed. The product is intended for subcutaneous, intraperitoneal, or intravenous injection or for oral administration. The precise structure of Technetium Tc 99m Sulfur Colloid Injection is not known at this time. 11.1 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours 4 . The principal photon that is useful for detection and imaging studies is listed in Table 7. Table 7. Principal Radiation Emission Data 4 Radiation Mean Percent Per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 4 Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981. 11.2 External Radiation The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr at 1cm. The first half-value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 8. For example, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. Table 8. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 9. Table 9. Physical Decay Chart: Tc 99m, half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time 1.000 6 0.501 1 0.891 7 0.447 2 0.794 8 0.398 3 0.708 9 0.355 4 0.631 10 0.316 5 0.562 11 0.282 - - 12 0.251

RUBY-FILL RUBIDIUM RB 82
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

11.1 Chemical Characteristics RUBY-FILL Rubidium Rb 82 Generator contains accelerator-produced Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means for obtaining sterile non-pyrogenic solutions of rubidium Rb 82 chloride injection. The chemical form of Rb 82 is 82 RbCl. The amount (mCi) of Rb 82 obtained in each elution will depend on the potency of the generator. When used with the RUBY Rubidium Elution System, the generator provides ± 10% accuracy for rubidium Rb 82 chloride doses between 370 to 2220 MBq (10 to 60 mCi). When eluted at a rate of 15 to 30 mL/minute, each generator eluate at the end of elution should not contain more than 0.02 mcCi (0.74 kBq) of Sr 82 and not more than 0.2 mcCi (7.4 kBq) of Sr 85 per mCi of rubidium Rb 82 chloride injection, and not more than 1 mcg of tin per mL of eluate. 11.2 Physical Characteristics Rb 82 decays by positron emission and associated gamma emission with a physical half-life of 75 seconds. Table 5 shows the annihilation photons released following positron emission which are useful for detection and imaging studies. The decay modes of Rb 82 are: 95.5% by positron emission, resulting in the production of annihilation radiation, i.e., two 511 keV gamma rays; and 4.5% by electron capture, resulting in the emission of “prompt” gamma rays of predominantly 776.5 keV. Both decay modes lead directly to the formation of stable Kr 82. TABLE 5 Principal Radiation Emission Data Radiation Mean Percent Per Disintegration Mean Energy (keV) Annihilation photons (2) 191.01 511 (each) Gamma rays 13 to 15 776.5 The specific gamma ray constant for Rb 82 is 6.33 R cm 2 / mCi h (1.23 × 10 -12 C m 2 / kg MBq s). The first half-value layer is 0.53 cm of lead (Pb). Table 6 shows a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb. For example, the use of a 6.15 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. TABLE 6 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Attenuation Factor 0.53 0.5 1.68 10 -1 3.55 10 -2 6.15 10 -3 9.3 10 -4 Sr 82 (half-life of 25 days; 600 hrs.) decays to Rb 82. To correct for physical decay of Sr 82, Table 7 shows the fractions that remain at selected intervals after the time of calibration. TABLE 7 Physical Decay Chart: Sr 82 half-life 25 days Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining 0* 1.000 21 0.559 41 0.321 1 0.973 22 0.543 42 0.312 2 0.946 23 0.529 43 0.304 3 0.920 24 0.514 44 0.295 4 0.895 25 0.500 45 0.287 5 0.871 26 0.486 46 0.279 6 0.847 27 0.473 47 0.272 7 0.824 28 0.460 48 0.264 8 0.801 29 0.448 49 0.257 9 0.779 30 0.435 50 0.250 10 0.758 31 0.423 51 0.243 11 0.737 32 0.412 52 0.237 12 0.717 33 0.401 53 0.230 13 0.697 34 0.390 54 0.224 14 0.678 35 0.379 55 0.218 15 0.660 36 0.369 56 0.212 16 0.642 37 0.358 57 0.206 17 0.624 38 0.349 58 0.200 18 0.607 39 0.339 59 0.195 19 0.591 40 0.330 60 0.189 20 0.574 * Calibration time To correct for physical decay of Rb 82, Table 1 shows the fraction of Rb 82 remaining in all 15 second intervals up to 300 seconds after time of calibration [see Dosage and Administration ( 2.6 )].

Sodium Iodide I 131 Diagnostic SODIUM IODIDE I 131
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

11.1 Chemical Characteristics Sodium Iodide I 131 Capsules Diagnostic is a radiodioactive diagnostic agent containing sodium iodide I 131 and supplied for oral administration in a gelatin capsule. Each capsule contains no-carrier-added sodium iodide I 131, disodium edetate dihydrate USP as a stabilizer, sodium thiosulfate pentahydrate USP as a reducing agent, and dibasic sodium phosphate anhydrous USP. Sodium Iodide I 131 is designated chemically as Na131I and has a molecular weight of 153.99. 11.2 Physical Characteristics Iodine I 131 decays by beta emission and associated gamma emission with a physical half-life of 8.04 days. The principal radiation emissions are listed in Table 4. Table 4 Principal Radiation Emission Data from Decay of Sodium Iodide I 131 Radiation Mean % per Disintegration Mean Energy (keV) Beta-1 2.13% 69.4 Beta-3 7.20% 96.6 Beta-4 89.4% 191.6 Gamma-7 6.14% 284.3 Gamma-14 81.2% 364.5 Gamma-18 7.12% 637.0 11.3 External Radiation The specific gamma-ray constant for iodine I 131 is 4.26 x 10 -13 C•m 2 •kg -1 •MBq -1 •s -1 (2.2 R•cm 2 /mCi•hr). The first half-value thickness of lead (Pb) for iodine I 131 is 0.27 cm. A range of values for the relative attenuation of the radiation emitted by iodine I 131 that results from interposition of various thicknesses of Pb is shown in Table 5. For example, the use of 2.59 cm of Pb will decrease the external radiation exposure by a factor of about 100. Table 5 Radiation Attenuation of Iodine I 131 by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.27 0.5 0.56 0.25 0.99 10 -1 2.59 10 -2 4.53 10 -3 To correct for physical decay of iodine I 131, the fractions that remain at selected intervals after the time of calibration are shown in Table 6. Table 6 Physical Decay Chart: Iodine I 131, Half-Life 8.04 days Days Fraction Remaining Days Fraction Remaining Days Fraction Remaining 0 Calibration Time 1.000 11 0.388 22 0.151 1 0.918 12 0.356 23 0.138 2 0.842 13 0.327 24 0.127 3 0.773 14 0.300 25 0.116 4 0.709 15 0.275 26 0.107 5 0.651 16 0.253 27 0.098 6 0.597 17 0.232 28 0.090 7 0.548 18 0.213 29 0.083 8 0.503 19 0.195 30 0.076 9 0.461 20 0.179 10 0.423 21 0.164

Technetium Tc 99m Medronate TECHNETIUM TC 99M MEDRONATE
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

DRAXIMAGE® MDP-25 Kit for the Preparation of Technetium Tc 99m Medronate Injection For Intravenous Use DIAGNOSTIC – FOR SKELETAL IMAGING DESCRIPTION The kit consists of reaction vials which contain the sterile, non-pyrogenic,non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by intravenous injection. MDP-25 reaction vials are intended to be used as multidose vials. Each 10 mL MDP-25 reaction vial contains 25.0 mg medronic acid and not less than 2.0 mg of stannous chloride dihydrate (maximum total tin expressed as stannous chloride dihydrate 3.0 mg) and 5.0 mg of p-aminobenzoic acid in lyophilized form under an atmosphere of nitrogen. The pH is adjusted to 6.8 to 6.9 with HCI or NaOH prior to lyophilization. The addition of sterile, non-pyrogenic, and oxidant-free sodium pertechnetate Tc-99m sterile solution produces a rapid labeling which is essentially quantitative and which remains stable in vitro throughout the 12-hours life of the preparation. No bacteriostatic preservative is present. The structural formula of medronic acid is: PHYSICAL CHARACTERISTICS Technetium Tc-99m decays by isomeric transition with a physical half-life of 6.02 hours. 1 The principal photon that is useful for detection and imaging studies is listed in Table 1. Table 1 Principal Radiation Emission Data Radiation Mean % / Disintegration Energy (keV) Gamma-2 89.07 140.5 EXTERNAL RADIATION The specific gamma ray constant for Tc-99m is 0.78 R/mCi-hr at 1 cm. The first half value layer is 0.017 cm of lead. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1000. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead is shown in Table 2. Table 2 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.08 0.16 0.25 0.33 0.5 10 -1 10 -2 10 -3 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. 1 Kocher, David C.: “Radioactive Decay Data Tables”, DOE/TIC-11026, 108 (1981) Table 3 Physical Decay Chart: Tc-99m, half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0* 1 2 3 4 5 6 1.000 0.891 0.794 0.708 0.631 0.562 0.501 7 8 9 10 11 12 0.447 0.398 0.355 0.316 0.282 0.251 *Calibration time Structure

TECHNETIUM Tc 99m MERTIATIDE TECHNETIUM TC 99M MERTIATIDE
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA FDA Rx Only

11.1 Chemical Characteristics Kit for the Preparation of Technetium Tc 99m Mertiatide Injection is a sterile, multiple-dose kit for the preparation of technetium Tc 99m mertiatide injection, a radioactive diagnostic agent for intravenous use. The active ingredient, betiatide, is N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine and has a molecular weight of 367.38 g/mol. After reconstitution with sodium pertechnetate Tc 99m injection, the radioactive agent technetium Tc 99m mertiatide (disodium[N-[N-[N- (mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) is formed in situ. Each 10 mL vial contains 1 mg betiatide, 20 mg lactose monohydrate, 40 mg sodium tartrate dihydrate, 0.07 mg (minimum) stannous chloride dihydrate and 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate. Prior to lyophilization, hydrochloric acid is added for pH adjustment. The vial contents are sealed under argon. After radiolabeling with sodium pertechnetate Tc 99m injection, each vial contains up to 3,700 MBq (100 mCi) of technetium Tc 99m mertiatide in 0.9% sodium chloride injection in approximately 10 mL volume as a sterile, clear, and colorless solution with a pH between 5 and 6. betiatide-chem-stuct tc-99m-mertiatide 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging is listed in Table 2. Table 2. Principal Radiation Emission Data Radiation M Mean % per Disintegration Energy (keV) Gamma-2 89.07 140.5 To correct for physical decay of the radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3. Table 3. Physical Decay Chart: Technetium Tc 99m, Half-life 6.02 Hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 * Calibration Time 11.3 External Radiation The specific gamma ray constant for technetium-99m is 0.78 R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for technetium-99m is 0.017 cm. The use of 0.25 cm of Pb, for example, will decrease the external radiation exposure by a factor of about 1,000. Table 4 displays the radiation attenuation by lead shielding. Table 4. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4

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