Chlortetracycline Hydrochloride
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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-(4a,4aa,5aa,6b,12aa)]-.
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 900µg 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 820µg 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.
USP Reference standards á11ñ—
USP Chlortetracycline Hydrochloride RS.USP Oxytetracycline RS.USP Tetracycline Hydrochloride RS.
Identification—
A:
Proceed as directed for Method IIunder Identification—Tetracyclines á193ñ,using a methanol solution containing 0.5mg per mLas the Test solutionand a methanol solution containing in each mL0.5mg of USP Chlortetracycline Hydrochloride RS,0.5mg of USP Oxytetracycline RS,and 0.5mg of USP Tetracycline Hydrochloride RSas the Resolution solution.
B:
Asolution (1in 20)meets the requirements of the tests for Chloride á191ñ.
Specific rotation á781Sñ:
between -235
and -250.
and -250.
Test solution:
5mg per mL,in water,that has been allowed to stand in the dark for 30minutes.
Crystallinity á695ñ:
meets the requirements.
Sterility á71ñ—
Where the label states that Chlortetracycline Hydrochloride is sterile,it meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,6g of specimen aseptically dissolved in 200mLof Fluid Dbeing used.
pHá791ñ:
between 2.3and 3.3,in a solution containing 10mg per mL.
Loss on drying á731ñ—
Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 2.0%of its weight.
for 3hours:it loses not more than 2.0%of its weight.
Assay—
Proceed with Chlortetracycline Hydrochloride as directed under Antibiotics—Microbial Assays á81ñ.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 459
Phone Number:1-301-816-8335