GUAIPHENESIN IP

Molecular Formula: C10H14O4
Molecular Weight : 198.2

CAS No. : [93–14–1]

Application:

Expectorant.

General properties:

White crystals or crystalline powder.

Sr. No.	Tests	Specification
1	DESCRIPTION	A white or almost white, crystalline powder.
2	SOLUBILITY	Soluble in ethanol (95%) & in chloroform, sparingly soluble in water, slightly soluble in ether.
3	IDENTIFICATION A) IRB) HPLC C) MELTING POINT	Determine by Infra-Red absorption spectrophotometry, compare the spectrum with that obtained with Guaiphenesin IP or with the reference spectrum of Guaiphenesin. In the test of Related substances, the principal peak in the chromatogram obtained with the solution corresponds to that in the chromatogram obtained with reference solution (a). Between 79°C and 83°C.
4	APPEARANCE OF SOLUTON	A 2.0% w/v solution is clear and colourless.
5	pH	5.0 to 7.0, determine in a 1.0% solution.
6	RELATED SUBSTANCES 1) IMPURITY A: GUAIACOL 2) IMPURITY B: β-ISOMER 3) IMPURITY C: BISETHER 4) IMPURITY D: 1,3-BIS (2-METHOXYPHENOxy) PROPAN-2-OL 5) UNSPECIFIED IMPURITIES 6) TOTAL IMPURITIES	Not more than 0.1% Not more than 1.0% Not more than 0.5%Not more than 0.5% Each impurity not more than 0.5% Not more than 1.0%
7	CHLORIDES & MONOCHLOROHYDRINS	Not more than 250 ppm
8	HEAVY METALS	Not more than 20 ppm
9	SULPHATED ASH	Not more than 0.1%
10	LOSS ON DRYING	Not more than 0.5%
11	ASSAY ON DRIED BASIS	Not less than 98.0% and not more than 101.5%.

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