Description

Acyclovir Ep Impurity M is a designated pharmaceutical reference standard used for analytical purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiviral drug Acyclovir by serving as a known impurity marker during quality control testing. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of antiviral medications.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Acyclovir Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC) for Acyclovir.
• Used in stability studies to monitor impurity profiles and degradation pathways of Acyclovir under various storage conditions.
• Essential for regulatory compliance and filing, supporting documentation for regulatory submissions (e.g., to FDA, EMA).
• Employed in quality control (QC) laboratories for routine batch release testing of Acyclovir API.
• Used as a system suitability standard in chromatographic analysis to ensure the performance of the analytical system.
• Supports research and development of new synthetic routes and purification processes for Acyclovir.

Basic Information

Item	Details
Product Name	Acyclovir Ep Impurity M
CAS No.	91702-60-2
Molecular Formula	C8H11N5O3
Molecular Weight	225.21 g/mol
Synonyms	2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethanol; 9-[(2-Hydroxyethoxy)methyl]guanine Impurity M; Acyclovir Related Compound M; Acyclovir Impurity M; EP Impurity M of Acyclovir; Guanine, 9-[(2-hydroxyethoxy)methyl]-; ACV Impurity M
EINECS	Contact for details

Quality Control

Our Acyclovir Ep Impurity M is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided, detailing results from HPLC purity assay, related substances, residual solvents, and other relevant tests. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.