Demeclocycline Hydrochloride Tablets
» Demeclocycline Hydrochloride Tablets 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.
Identification
Shake a suitable quantity of finely powdered Tablets 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.
Dissolution 711
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 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 finely ground Tablet powder, accurately weighed, in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 2% of its weight.
Assay
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system
Prepare as directed in the Assay under Demeclocycline.
Assay preparation
Weigh and finely powder not fewer than 10 Tablets. 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 of 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 Tablets taken by the formula:
0.05CE(rU / rS)
in which the terms are as defined therein.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 2067
Pharmacopeial Forum: Volume No. 30(2) Page 475
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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