Product Name: Dextromethorphan Hydrobromide

Expiry date: 3 Years

Test

Specification

Test result

Appearance

Practically white crystals or crystalline powder

White crystalline powder

Identification

A.FT-IR

The sample spectrum corresponds to that of the reference standard

Conforms

B.UV

No more than 3.0% difference of RS (on anhydrous basis )

1.6%

C. Bromide test

Yellowish white precipitate formed

Conforms

Specific rotation A

1.8% W/V in water; not more than 1.0% difference of RS at 325nm and 25°C (on anhydrous basis)

0.28%

Specific rotation B

2.0% W/V in 0.1M HCl: +28°to +30°at 589nm and 20°C (on anhydrous basis)

+29.2°

Clarity of solution

5.0% W/V in alcohol:

Conforms

PH

5.2-6.5 (1 in 100 water solution )

6.2

Acidity or alkalinity

Not more than 0.4ml of 0.01MHCl consumed

0.25ml

Water (by KF Titratation )

4.0%-5.5%

5.0%

Relates substances

a)       For each of impurities A,B,C,D, not more than 0.5%

b)      Among impurities A,B,C,D, not more than one greater than 0.25%

c)       For each of unspecified impurities, not more than 0.10%

d)      Total impurities not more than 1.0%

Impurities A,B,C,D: not detected

0

<0.05%

<0.05%

Residue on ignition

Not more than 0.1%

0.06%

N,N-Dimethyaniline

Not more htan 0.001%

Conforms

Phenolic compounds

No blue-green color develops

Conforms

Assay A (by HPLC)

98.0%-102.0%(on anhydrous basis)

100.1%

Assay B (by titration)

99.0%-101.0% (on anhydrous basis)

100.8%

Residue solvents

Methanol ≤ 3000ppm

Toluene ≤890ppm

Acetone ≤5000ppm

20.4ppm

3.0ppm

7.4ppm

Storage

Preserve in tight containers; protected from light

Compliance statement

The product meets USP34 and EP7 monographs for Dextromethorphan Hydrobromide