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Demeclocycline Hydrochloride
C21H21ClN2O8·HCl 501.31

2-Naphthacenecarboxamide, 7-chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-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-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride [64-73-3].
» Demeclocycline Hydrochloride has a potency of not less than 900 µg of C21H21ClN2O8·HCl per mg, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
A: It responds to Identification test A under Demeclocycline, except that its absorptivity, calculated on the dried basis, is between 95.8% and 104.2% of that of the USP Demeclocycline Hydrochloride RS, the potency of the Reference Standard being taken into account.
B: It responds to Identification test B under Demeclocycline, except that the ratio is 0.9 to 1.1.
Crystallinity 695: meets the requirements.
pH 791: between 2.0 and 3.0, 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—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Demeclocycline.
Assay preparation— Transfer about 50 mg of Demeclocycline Hydrochloride, accurately weighed, to a 50-mL volumetric flask, dissolve in 0.01 N hydrochloric acid, dilute with 0.01 N hydrochloric acid to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Demeclocycline. Calculate the quantity, in µg, of demeclocycline hydrochloride (C21H21ClN2O8·HCl) in each mg of the Demeclocycline Hydrochloride taken by the formula:
50(CE / W)(rU / rS),
in which W is the quantity, in mg, of the Demeclocycline Hydrochloride taken, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 630
Phone Number : 1-301-816-8223