Naltrexone hydrochloride usp monograph

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Naltrexone hydrochloride usp monograph

Posted Jun 15, 2016 by Admin

This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or recent use (in the last 7 to 14.At the time the specimen is injected into the chromatograph, the percentage of Solution A is 100; over the next 35 minutes, the proportion of Solution B is increased linearly to 100, and then over the next minute, decreased linearly to 100 of Solution A. Limit of total solvents Internal standard stock solution Transfer 6.0 mL of isopropyl alcohol to a 500-mL volumetric flask, dilute with water to volume, and mix. NOTET he isopropyl alcohol must be free of alcohol impurities.

NOTET he relative response factor is 0.3 for 2,2 -bisnaltrexone and 10-ketonaltrexone, and 1.0 for all other related compound peaks. Not more than 0.5 of any individual related compound is found; and the total of all related compounds is not more than 1.5.Add 1.0 mL triethylamine and 600 mL of methanol, and mix. Adjust with glacial acetic acid to a pH of 6.5 0.1. Filter and degas prior to use. Mobile phase Use variable mixtures of Solution A and Solution B as directed for Chromatographic system.

Titrate with 0.1 N silver nitrate VS, determining the endpoint potentiometrically. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of chloride: between 9.20 and 9.58, calculated on the anhydrous, solvent-free basis is found.Chromatographic system (see Chromatography 621 ) The liquid chromatograph is equipped with a 280-nm detector and a 3.9-mm15-cm column that contains packing L1 and is programmed to provide, at a flow rate of about 1 mL per minute, a variable mixture of Solution A and.

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Allow the system to equilibrate until the late eluting peak has been observed, approximately 17 minutes later. Chromatograph about 20 L of the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.55 for noroxymorphone, 0.70 for.Add 1.0 mL of triethylamine and 200 mL of methanol, and mix. Adjust with glacial acetic acid to a pH of 6.5 0.1. Filter and degas prior to use. Solution B Dissolve about 1.08 g sodium 1-octanesulfonate and about 23.8 g sodium acetate in 400.

Specific rotation 781S : between 187 and 197, calculated on the anhydrous, solvent-free basis. Test solution: 25 mg per mL, in water. Water, Method I 921 Determine the water content as directed.Packaging and storage Preserve in tight containers. USP Reference standards 11 USP Naltrexone RS. USP Naltrexone Related Compound A RS. Completeness of solution 641 A 650-mg portion dissolves in 10 mL of water to yield a clear solution.

Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.24 for methanol, 0.53 for alcohol, and 1.0 for isopropyl alcohol. Procedure Separately inject equal volumes (about 5 L) of the Standard solution and the Test.Internal standard solution. Transfer 5.0 mL of the Internal standard stock solution to a 100-mL volumetric flask, dilute with water to volume, and mix. Standard solution Prepare a solution of methanol and alcohol (C2H5OH) in water to obtain a solution having a known concentration of.

Extract with three 5-mL portions of chloroform, filter the extracts through a dry filter, collecting the filtrate in a small flask. Evaporate the filtrate on a steam bath to dryness, and dry the residue at 105 for one hour.Content of chloride Transfer about 300 mg, accurately weighed, to a 250-mL conical flask, add 50 mL of methanol, 50 mL of water, and 3 mL of nitric acid, and mix to dissolve.