Demeclocycline Hydrochloride Capsules
» Demeclocycline Hydrochloride Capsules contain not less than 90.0 percent and not more than 125.0 percent of the labeled amount of demeclocycline hydrochloride (C21H21ClN2O8·HCl).
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification Shake a suitable quantity of Capsule contents with methanol to obtain a solution containing about 1 mg of demeclocycline hydrochloride per mL, and filter. Using the filtrate as the Test Solution, proceed as directed for Method II under IdentificationTetracyclines 193.
Medium: water; 900 mL.
Apparatus 2: 75 rpm.
Time: 45 minutes.
Procedure Determine the amount of C21H21ClN2O8 dissolved from UV absorption at the wavelength of maximum absorbance at about 274 nm on filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Demeclocycline Hydrochloride RS in the same Medium.
Tolerances Not less than 75% (Q) of the labeled amount of demeclocycline (C21H21ClN2O8) is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Loss on drying 731 Dry about 100 mg of Capsule contents, accurately weighed, in a capillary-stoppered bottle in vacuum at 60 for 3 hours: the material loses not more than 2.0% of its weight, except that if the Capsules contain starch the material loses not more than 8.0% of its weight.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Prepare as directed in the Assay under Demeclocycline.
Assay preparation Remove, as completely as possible, the contents of not fewer than 10 Capsules, and weigh. Mix, and transfer an accurately weighed portion of the powder, equivalent to about 50 mg of demeclocycline hydrochloride (C21H21ClN2O8·HCl), to a 50-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix. Sonicate for 5 minutes, and centrifuge for 5 minutes. Pass a portion of the supernatant through a suitable filter having a 1.5-µm or finer porosity, and use the clear filtrate as the Assay preparation.
Procedure Proceed as directed for Procedure in the Assay under Demeclocycline. Calculate the quantity, in mg, of demeclocycline hydrochloride (C21H21ClN2O8·HCl) in the portion of Capsule contents taken by the formula:
0.05CE(rU / rS)in which the terms are as defined therein.
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USP35NF30 Page 2818Pharmacopeial Forum: Volume No. 29(3) Page 625