Acyclovir EP Impurity P (9-(2-Hydroxyethyl)guanine), PurCert

PurCert


Linear Formula:  C7H9N5O2
Molecular Weight:  195.18 g/mol
CAS Number: 23169-33-7

Properties

Assay Purity >= 97 %
Form Solid

Safety Information

Hazard Statement(s) H302-H315-H319-H335
Precautionary Statement  P261-P264-P270-P271-P280-P302+P352-P304+P340-P305+P351+P338-P312-P330-P362-P403+P233-P501
GHS Pictogram
Signal word Warning
Storage Temp. 2-8 °C
UN Number NA

Description

Application
Acyclovir EP Impurity P is used as a pharmaceutical reference standard for the identification quantification and qualification of Impurity P during the quality control and stability testing of acyclovir drug substances and drug products according to European Pharmacopoeia (EP) requirements.

Purpose
Its purpose is to ensure that the level of Impurity P in acyclovir complies with established pharmacopoeial specifications thereby supporting product quality safety and regulatory compliance.

General Description
Acyclovir EP Impurity P is a specified related substance listed in the European Pharmacopoeia and is supplied as a certified reference standard for use in validated analytical methods such as high-performance liquid chromatography (HPLC).