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-(4a,4aa,5aa,6b,12aa)-.
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 900µg of C21H21ClN2O8·HCl per mg,calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: It responds to Identificationtest Aunder 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 Identificationtest Bunder Demeclocycline,except that the ratio is 0.9to 1.1.
Crystallinity á695ñ: meets the requirements.
pHá791ñ: between 2.0and 3.0,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.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Demeclocycline.
Assay preparation— Transfer about 50mg of Demeclocycline Hydrochloride,accurately weighed,to a 50-mLvolumetric flask,dissolve in 0.01Nhydrochloric acid,dilute with 0.01Nhydrochloric acid to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder 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 Wis the quantity,in mg,of the Demeclocycline Hydrochloride taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 578
Phone Number:1-301-816-8335