Active pharmaceutical ingredients orphenadrine citrate powder/Cas no: 4682-36-4

Tests

Results

Specification

CHARACTERS

Appearance

Complies

White or almost white,crystalline powder.

APPEARANCE OF SOLUTION(Current USP)

10ml HCL:Alcohol=1:27

Complies

Complies

Abs.23 (Current USP)

1g/10ml HCL /Alcohol=1:27-436nm

0.023

≤0.050

IDENTIFICATION(USP <815>)

I.R.Spectrum

Complies

Complies

IDENTIFICATION(Current USP)

UV:Absorbance difference

1.1%

≤3.0%

PE23.7E(Current USP)

Loss on drying

0.1%

≤0.5%

TEST (USP<281>)

Residue on ignition/sulphated asn

0.05%

≤0.1%

RELATED SUBSTANCES (Current USP)

Total impurities(HPLC)

0.3%

≤0.5%

Assay (Current USP)

Assay HPLC

99.5%

98.0-101.5%

MELTING  POINT

Melting range

136~138°C

134-138°C

RELATED SUBSTANCES (USP)

Ethyldimethyl[2-(2-methylbenzhydryloxy)ethyl]

ammonium chloride

ND

≤0.5%

2-Methylbenzhydrol

ND

≤0.5%

N,N-Dimethyl-2-(o-tolyl-o-xylyloxy)ethylamine

ND

≤0.5%

others

0.3%

≤0.5%

Total impurities

0.3%

≤0.5%

ORGANIC VOLATILE  IMPURITIES(USP)

Based on our knowledge of the manufacturing process and controlled handling and storage of this raw material,there is no potential for the organic volatile impurities listed relative to current USP <467>to be present(I.E..the listed impurities are not used in the manufacturing process,nor could they be introduced during the storage or handling of the raw material).

RESIDUAL SOLVENTS (ICH-Q3C)

Only class 3 solvents(CPMP/ICH/283/95)are likely to be present.Loss on drying is less than 0.5%

GUARANTEE PERIOD

Uses before this date 11/06/2012

Lot Released:Complies with all specifications of the USP30Testing instruction