2-(Ethylamino)-2-(2-thienyl)cyclohexanone hydrochloride [14176-50-2].
» Tiletamine Hydrochloride contains not less than 97.0 percent and not more than 103.0 percent of C12H17NOS·HCl.
Packaging and storage Preserve in tight containers.
Labeling Label it to indicate that it is for veterinary use only. Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Clarity of solution Dissolve 1.0 g of it in 10 mL of water: the solution is clear.
B: Ultraviolet Absorption 197U
Solution: 0.3 mg per mL.
Medium: 0.1 N hydrochloric acid.
Absorptivities at 234 nm do not differ by more than 3.0%.
C: It meets the requirements of the tests for Chloride 191.
Melting range 741: between 190 and 195, within a 2 range.
Bacterial endotoxins 85 Where the label states that Tiletamine Hydrochloride is sterile or must be subjected to further processing during the preparation of injectable dosage forms, it contains not more than 0.07 USP Endotoxin Unit per mg of tiletamine.
Sterility 71 Where the label states that Tiletamine Hydrochloride is sterile, it meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.0 and 5.0, in a solution (1 in 10).
Water, Method I 921: not more than 1.0%.
Residue on ignition 281: not more than 0.5%.
Heavy metals, Method II 231: 0.002%.
Chromatographic purity Prepare a test solution of Tiletamine Hydrochloride in methanol containing 50.0 mg per mL. Prepare a Standard solution in methanol containing 1.0 mg of USP Tiletamine Hydrochloride RS per mL. Prepare a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture as follows. Prewash the plate by developing it in a mixture of methanol and ether (8:2) to the top of the plate, and allow the plate to dry. Separately apply 5 µL of the test solution and the Standard solution to the plate, and develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, mark the solvent front, allow the plate to air-dry, and examine under short- and long-wavelength UV light: no individual secondary spot observed in the chromatogram obtained from the test solution is greater in size or intensity than the principal spot observed in the chromatogram obtained from the Standard solution, corresponding to 2%, and the total of any such spots observed does not exceed 3%.
Chloride content Transfer about 250 mg of it, accurately weighed, to a conical flask, add 5 mL of water, 5 mL of glacial acetic acid, and 50 mL of methanol, and swirl to dissolve. Add 1 drop of eosin Y TS, and titrate with 0.1 N silver nitrate VS to the endpoint when the granular precipitate first turns to a permanent pink color. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of chloride: between 13.24% and 14.06% is found.
Assay Transfer about 300 mg of Tiletamine Hydrochloride, accurately weighed, to a conical flask, add 70 mL of glacial acetic acid and 10 mL of mercuric acetate TS, and swirl to dissolve. Add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 25.98 mg of C12H17NOS·HCl.
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USP32NF27 Page 3744