Dextromethorphan hydrobromide USP32

Product name Dextromethorphan hydrobromide Batch No. KNCA0116 Sample quantity 50.00 gm A.R.NO 10000421898 Date of analysis 03.12.2009 Manufacture date DEC.2009 Expiry date NOV.2014 Ref. standard USP32 Packing 50g/bag TESTRESULTSPECIFICATIONDescription White crystalline powder Practically white crystals or crystalline powder having a faint odour. Solubility Complies Sparingly soluble in water, freely soluble in alcohol and in chloroform and insoluble in ether. Identification by a. IR Complies The infrared absorption spectrum of finely ground sample in potassium bromide dispersion compressed into a pellet, exhibits maxima only at the same wave lengths as that of a similar preparation of the corresponding Dextromethorphan HBr WS b. UV absorption 1.58% Absorbtivity at 278nm of sample (100μg/ml(on anhydrous basis)solution in 0.1N hydrochloric acid) do not differ from a similar preparation of Dextromethorphan Hydrobromide WS by more than 3.0% c. With silver Nitrate TS Complies A yellowish wihte precipitate formed when 5 drops of 2N nitric acid and 2ml of silver nitrate TS are added to 5ml of sample solution. Melting point 126.5°C with decomposition Melts at about 126°C with decomposition. Specific optical rotation at 25° 0.30% The specific rotation of the sample at 325nm do (on anhydrous basis) not differ from a similar preparation of (C=1,8 in water) Dextromethorphan hydrobromic WS, by more than 1.0% Ph (1 in 100) 6.38 Between 5.20 and 6.50 Water by KF 4.45% w/w Between 3.5and 5.5% w/w Residue on ignition 0.04% than 0.001% Not more than 0.1% w/w Limit of N,N-dimethylaniline Less than 0.001% Not more than 0.001% Limit of phenolic compounds Complies No blue-green colour develops Assay (on anhydrous basis) 99.58% w/w Not less than 98.0% and Not less than 102.0% w/w