Linagliptin EP Impurity E, PurCert

PurCert


Properties

Assay Purity >=99%
Density 1.40 ± 0.1g/cm3
Form Solid

Safety Information

Hazard Statement(s) NA
Precautionary Statement  NA
GHS Pictogram
Signal word NA
HS Code NA
Storage Temp. 2-8 °C
UN Number NA

Description

Application
Linagliptin EP Impurity E is used as a pharmaceutical reference standard for the identification and quantification of impurity E during the quality control method validation and stability testing of linagliptin drug substances and finished pharmaceutical products.

Purpose
The purpose of Linagliptin EP Impurity E is to ensure that the level of impurity E in linagliptin complies with the limits specified by the European Pharmacopoeia thereby supporting the safety quality and regulatory compliance of the medicine.

General Description
Linagliptin EP Impurity E is a specified organic impurity of linagliptin supplied as a certified European Pharmacopoeia reference standard and is commonly used in analytical techniques such as high-performance liquid chromatography (HPLC) for impurity profiling and pharmaceutical quality control.