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Chlortetracycline Hydrochloride
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C22H23ClN2O8·HCl 515.34

2-Naphthacenecarboxamide, 7-chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride [4S-(4,4a,5a,6,12a)]-.
7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride [64-72-2].
» Chlortetracycline Hydrochloride has a potency of not less than 900 µg of C22H23ClN2O8·HCl per mg.
NOTE—Chlortetracycline Hydrochloride labeled solely for use in preparing oral veterinary dosage forms has a potency of not less than 820 µg of C22H23ClN2O8·HCl per mg.
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— Where it is intended for use in preparing sterile dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of sterile dosage forms.
Identification—
A: Proceed as directed for Method II under Identification—Tetracyclines 193, using a methanol solution containing 0.5 mg per mL as the Test solution and a methanol solution containing in each mL 0.5 mg of USP Chlortetracycline Hydrochloride RS, 0.5 mg of USP Oxytetracycline RS, and 0.5 mg of USP Tetracycline Hydrochloride RS as the Resolution solution.
B: A solution (1 in 20) meets the requirements of the tests for Chloride 191.
Specific rotation 781S: between 235 and 250.
Test solution: 5 mg per mL, in water, that has been allowed to stand in the dark for 30 minutes.
Crystallinity 695: meets the requirements.
Sterility 71— Where the label states that Chlortetracycline Hydrochloride is sterile, it meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, 6 g of specimen aseptically dissolved in 200 mL of Fluid D being used.
pH 791: between 2.3 and 3.3, in a solution containing 10 mg per mL.
Loss on drying 731— Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 2.0% of its weight.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed with Chlortetracycline Hydrochloride as directed under Antibiotics—Microbial Assays 81.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 497
Phone Number : 1-301-816-8223