NAME :ORFENADRINA CITRATO

EXPIRY DATE:2 years

CAS NO.:

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)