(tet'' ra sye' kleen).
2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl- 1,11-dioxo-, [4S-(4,4a,5a,6,12a)]-.
Trihydrate 498.49 [6416-04-2].
» Tetracycline has a potency equivalent to not less than 975 µg of tetracycline hydrochloride (C22H24N2O8·HCl) per mg, calculated on the anhydrous basis.
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Label it to indicate that it is to be used in the manufacture of nonparenteral drugs only.
USP Reference standards 11
USP 4-Epianhydrotetracycline Hydrochloride RS
A: Ultraviolet Absorption 197U
Solution: 20 µg per mL.
Medium: 0.25 N sodium hydroxide.
Absorptivity 6 minutes after preparation, calculated on the anhydrous basis, at 380 nm is between 104.5% and 111.95% of that of USP Tetracycline Hydrochloride RS, the potency of the Reference Standard being taken into account.
B: The chromatogram of the Assay obtained as directed in the Assay exhibits a major peak for tetracycline, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
C: To 0.5 mg add 2 mL of sulfuric acid: a purplish red color is produced. Add the solution to 1 mL of water: the color becomes yellow.
D: Prepare a Test Solution in methanol containing the equivalent of 1 mg of tetracycline hydrochloride per mL, and proceed as directed for Method II under IdentificationTetracyclines 193.
Specific rotation 781S: between 260 and 280, calculated on the anhydrous basis.
Test solution: 5 mg per mL, in 0.1 N hydrochloric acid.
Crystallinity 695: meets the requirements.
pH 791: between 3.0 and 7.0, in an aqueous suspension containing 10 mg per mL.
Water, Method I 921: not more than 13.0%.
Heavy metals, Method II 231: 0.005%.
Limit of 4-epianhydrotetracycline Using the Diluting solvent, Chromatographic system, and Procedure set forth in the Assay, chromatograph a Standard solution prepared by dissolving an accurately weighed quantity of USP 4-Epianhydrotetracycline Hydrochloride RS in Diluting solvent to obtain a solution having a known concentration of about 10 µg per mL. Using the chromatogram so obtained and the chromatogram of the Assay preparation obtained as directed in the Assay, calculate the percentage of 4-epianhydrotetracycline in the Tetracycline taken by the formula:
10(CE / W)(rU / rS)in which CE is the concentration, in µg per mL, of USP 4-Epianhydrotetracycline Hydrochloride RS in the Standard solution, W is the weight, in mg, of Tetracycline taken to prepare the Assay preparation, and rU and rS are the 4-epianhydrotetracycline peak responses obtained from the Assay preparation and the Standard solution, respectively: not more than 2.0% is found.
Diluting solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Prepare as directed in the Assay under Tetracycline Hydrochloride.
Assay preparation Transfer about 45 mg of Tetracycline, accurately weighed, to a 100-mL volumetric flask, dissolve in Diluting solvent, dilute with the same solvent to volume, and mix.
Procedure Proceed as directed in the Assay under Tetracycline Hydrochloride. Calculate the quantity, in µg, of tetracycline hydrochloride (C22H24N2O8·HCl) equivalent in each mg of Tetracycline taken by the formula:
100(CP / W)(rU / rS)in which W is the weight, in mg, of Tetracycline taken to prepare the Assay preparation, and the other terms are as defined therein.
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USP35NF30 Page 4809