Printed on: Sat Jun 26 2021, 05:37:13 PM Official Status: Currently Official on 26-Jun-2021
(EST)
Printed by: Nguyen Nhan Official Date: Official Prior to 2013
Chlortetracycline Hydrochloride
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-(4α,4aα,5aα,6β,12aα)]-.
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.]
ci
Packaging and storage—Preserve in tight, light-resistant
ffi
containers.
Labeling—Where it is intended for use in preparing sterile
dosage forms, the label states that it is sterile or must be
O
https://online.uspnf.com/uspnf/document/1_GUID-3950EB4F-CA3F-4048-80B6-40ABF2439F56_1_en-US
DocId: 1_GUID-3950EB4F-CA3F-4048-80B6-40ABF2439F56_1_en-US
Document Type: USP @2021 USPC
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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 II under Identification—
Tetracyclines á193ñ, 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 á191ñ.
Specific rotation á781Sñ: 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 á695ñ: meets the requirements.
Sterility Tests á71ñ —Where the label states that
Chlortetracycline Hydrochloride is sterile, it meets the
al
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 á791ñ: between 2.3 and 3.3, in a solution containing
10 mg per mL.
Loss on drying á731ñ—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.
Assay—Proceed with Chlortetracycline Hydrochloride as
directed under Antibiotics—Microbial Assays á81ñ.
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