GUAIFENESIN EP

GUAIFENESIN EP

GUAIFENESIN EP

Molecular Formula: C10H14O4
Molecular Weight : 198.2

CAS No. : [93–14–1]

Application:

Expectorant.

General properties:

White crystals or crystalline powder.

SPECIFICATION FOR CHLORPHENESIN BP

 

Sr.
No.		TestsSpecification
1DESCRIPTION

White or almost white, crystalline powder.

2SOLUBILITYSparingly soluble in water, soluble in ethanol

(96%).

3

IDENTIFICATION
A) MELTING POINT
B) IR
C) TLC

Between 79°C and 83°C.
The Infra-Red spectrum of the sample is
concordant with that of Guaifenesin RS.
The Principal spot in the chromatogram
obtained with the test solution is similar in
position, colour and size to the principal spot
in the chromatogram obtained with the
reference solution.
4APPEARANCE OF SOLUTONDissolve 1 g sample in carbon dioxide-free
water, heat gently if necessary and dilute to
50 ml with water, is solution S.
Solution S is clear and colourless.
5ACIDITY OR ALKALINITYFor 10 ml solution S, NMT 0.1 ml of 0.01 M
NaOH is required or for 10 ml solution S,
NMT 0.01 M HCl is required.
6RELATED SUBSTANCES
1) IMPURITY A: GUAIACOL
2) IMPURITY B: β-ISOMER
3) IMPURITY C: BISETHER
4) IMPURITY D: 1,3-BIS
(2-METHOXYPHENOL)
PROPAN-2-OL
3) UNSPECIFIED
IMPURITIES
4) TOTAL IMPURITIES
5) DISREGARD LEVEL

Not more than 0.03%
Not more than 0.5%
Not more than 0.1%

Not more than 0.1%
Each impurity not more than 0.05%
Not more than 0.7%
Not more than 0.05%

7CHLORIDES &
MONOCHLOROHYDRINS		Not more than 250 ppm
8LOSS ON DRYINGNot more than 0.5%
9SULFATED ASHNot more than 0.1 %
10ASSAY HPLC

Not less than 98.0% and not more than 102.0% on dried basis,

Storage condition: store in a well closed container.
Safety. Environment. Regulation: Refer to MSDS of GUAIFENESIN.