Tetracycline Tablets

General Notices

Action and use

Tetracycline antibacterial.

Definition

Tetracycline Tablets contain Tetracycline Hydrochloride. They are coated.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of tetracycline hydrochloride, C22H24N2O8,HCl

95.0 to 105.0% of the stated amount.

Identification

A. Comply with test A described under Tetracycline Capsules using the following solution as solution (1). Extract a quantity of the powdered tablets containing 10 mg of Tetracycline Hydrochloride with 20 mL of methanol, centrifuge and use the supernatant liquid.
B. Extract a quantity of the powdered tablets containing 25 mg of Tetracycline Hydrochloride with 25 mL of methanol for 20 minutes, filter and evaporate the filtrate to dryness on a water bath. To 0.5 mg of the residue add 2 mL of sulfuric acid; a purplish red colour is produced. Add 1 mL of water; the colour changes to deep yellow.
C. The residue obtained in test B yields the reactions characteristic of chlorides, Appendix VI.

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using as the medium 900 mL of 0.1m hydrochloric acid and rotating the basket at 100 revolutions per minute. Withdraw a sample of 10 mL of the medium. Measure the absorbance of the filtered sample, suitably diluted if necessary, at the maximum at 353 nm, Appendix II B. Calculate the total content of tetracycline hydrochloride, C22H24N2O8,HCl, in the medium taking 310 as the value of A(1%, 1 cm) at the maximum at 353 nm.

4-Epitetracycline hydrochloride

Complies with test described under Tetracycline Capsules. For solution (1) shake a quantity of the powdered tablets containing 25 mg of Tetracycline Hydrochloride with 80 mL of 0.01m methanolic hydrochloric acid, dilute to 100 mL with the same solvent, mix and filter if necessary.

Anhydrotetracycline hydrochloride and 4-epianhydro-tetracycline hydrochloride

Complies with the test described under Tetracycline Capsules. For solution (1) shake a quantity of the powdered tablets containing 25 mg of Tetracycline Hydrochloride with 20 mL of 0.01m methanolic hydrochloric acid, dilute to 25 mL with the same solvent, mix and filter if necessary.

Loss on drying

When dried at 60° at a pressure not exceeding 0.7 kPa for 3 hours, the powdered tablets lose not more than 3.0% of their weight. Use 1 g.

Assay

Weigh and powder 20 tablets and carry out the Assay described under Tetracycline Capsules. For solution (1) shake a quantity of the powdered tablets containing 25 mg of Tetracycline Hydrochloride with 80 mL of 0.01m methanolic hydrochloric acid, dilute to 100 mL with the same solvent, mix and filter if necessary.

Calculate the content of C22H24N2O8,HCl in the tablets using the declared content of C22H24N2O8,HCl in tetracycline hydrochloride BPCRS.