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

TEST

RESULT

SPECIFICATION

Description

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