TELMISARTAN

Name

Telmisartan

Molecular Formula

C33H30N4O2

Molecular Weight

514.63

QualityStandard

EP/USP

Package Size

25kg/drum

Brief Introduction

Telmisartan is an angiotensin II receptor antagonist (angiotensin receptor blocker, ARB)
used in the management of hypertension. It was discovered by Boehringer Ingelheim
and launched in 1999 as Micardis.

Items

Specifications

Results

Appearance

White or slightly yellowish crystalline powder

White crystalline powder

Solubility

Practically insoluble in water,slightly soluble in methanol,sparingly soluble in Methylene chloride.It dissolves in 1M sodium hydroxide.

Conform

Identification

IRspectrumshould comply with the CRS

Conform

Appearance of solution

The solution is not more intensely coloured than reference solution Y4

Conform

Loss on drying

Not more than 0.5%

0.10%

Sulphate ash

Not more than 0.1%

0.09%

.0%

Related substance

Impurity A: not more than 0.15%

0.006%

Impurity B:not more than 0.15%

0.003%

Impurity C: not more than 0.2%

N.D

Impurity D: not more than 0.2%

0.004%

Impurity E: not more than 0.10%

N.D

Impurity F: not more than 0.10%

0.009%

Impurity G: not more than 0.10%

0.01%

Impurity I: not more than 0.10%

0.002%

Impurity J: not more than 0.10%

0.03%

Max individualunknownimpurity: not more than 0.10%

0.03%

Total impurity: not more than 1.0%

0.21%

Residual solvent

Methanol: not more than 3000ppm

N.D

MIBK: not more than 5000ppm

N.D

Isopropanol: not more than 5000ppm

N.D

Assay(dried substance)

99.0-101.0%

100.0%

Conclusion:Complies with EP 7.2