API TESTING SPECIFICATION

Name: Dexchlorpheniramine maleate USP

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

Code: HDCTM

CAS: 2438-32-6

Storage: Preserve in tight, light-resistant containers.

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

M.F.: C16 H19 CIN2 C4 H4 O4

M.W.: 390.86 g/mole

 

Test

 

Specification

Description

:

White, odorless, crystalline powder.

Solubility

:

Freely soluble in water, Soluble in alcohol and in chloroform; slightly soluble in benzene and in ether.

Identification - A

:

The Infra red absorption spectrum of the sample exhibits maxima only at the same wavelengths as that of similarly prepared standard.

Identification - B

:

Maxima and minima of test observed at the same wavelength as that of standard and absorbance ratio at maximum should within 97.00 to 103.00% of standard.

Melting range

:

Between 110.0 and 115.0 0C

Specific rotation

:

Between +39.50 and +43.000

pH

:

Between 4.00 and 5.00 pH

Loss on drying

:

Not more than 0.50%.

Residue on ignition

:

Not more than 0.200%.

Related Compound

:

Not More Than 2.00%

Residual Solvents

:

Toluene not more than 890.00 ppm.
Ethylene chloride not more than 1870.00 ppm.
Methanol not more than 3000.00 ppm.
Ethyl acetate not more than 1000.00 ppm

Assay

:

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

*In-house tests

:

(As per customer requirement)

*Colour

 

The test solution should remain clear and free from blue coloration.

*Microbial limits

 

NMT 500 cfu/g

 

 

Absence of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella species and objectionable organisms.

End of specification