Metformin EP Impurity A, PurCert

PurCert


Linear Formula:  C2H4N4
Molecular Weight:  84.08 g/mol
CAS Number: 461-58-5

Properties

Water Solubility Slightly soluble
Assay Purity >=98%
M pt. 208-211 °C
Density 1.4 g/cm3 (20 °C)
Form Solid

Safety Information

GHS Pictogram
HS Code 29262000
Storage Temp. 2-8 °C
Storage Class 11 - Combustible Solids
UN Number NA

Description

Application
Metformin EP Impurity A is used as a pharmaceutical reference standard for the identification quantification and quality control of impurities in Metformin drug substances and finished pharmaceutical products according to European Pharmacopoeia (EP) requirements.

Purpose
The purpose of Metformin EP Impurity A is to ensure the safety quality and regulatory compliance of Metformin by monitoring and controlling impurity levels during manufacturing stability testing and batch release.

General Description
Metformin EP Impurity A is a specified organic impurity listed in the European Pharmacopoeia and serves as a certified reference material for analytical method validation and routine pharmaceutical quality testing it is not intended for therapeutic use.