API TESTING SPECIFICATION

Name: Dexchlorpheniramine Maleate BP

T.S.No.: SPEC/API/HDCTM-018/B/01
Issue Date: 01/03/2006

Code: HDCTM

CAS: 2438-32-6

Storage: Store protected from light.

Supersede: SPEC/API/ HDCTM-018/B
Date: 01/04/2002

M.F.:  C20 H23 CIN2 O4

M.W.: 390.90g/mole

 


Test

 

Specification

Characters

:

A white crystalline powder.

Solubility

:

Very soluble in water, freely soluble in alcohol, in methanol and in methylene chloride

Identification

:

Test A,C and E OR Tests A,B,D and E.

Identification A

:

It should comply with the test for specific optical rotation.

Identification B  ( Melting Range)

:

110.00C to 115.00C.

Identification C

:

The Infra red absorption spectrum should concordant with the spectrum obtained from Dexchlorpheniramine Maleate working Standard.

Identification D

:

The chromatogram obtained with the test solution should show two clearly separated spots. The upper spot should be similar in position and size to the spot in the chromatogram obtained with reference solution.

Identification E

:

The solution should give the reaction of chlorides

Appearance of solution

:

The solution should be clear and not more Intensely coloured than reference solution BY6.

pH

:

4.50 to 5.50.

Specific optical rotation

:

+22.000 to  +23.000 on dried basis

Related substance  (By GC ) :

:

Any individual impurity: Not more than 0.40%.
Total impurity: Not more than 1.00%.

Enantiomeric Purity ( By HPLC )

:

(R) Enantiomer: Not more than 2.00%.
Any Other Individual Enantiomer: Not more than 0.50%.

Heavy metals

 

Not more than 20ppm.

Loss On Drying    (At 65.00C)

 

Not more than 0.50%w/w

Sulfated Ash

 

Not more than 0.100 %w/w

Assay

 

98.00% to 100.50% w.r.t. dried substance.

End of specification