Description

Acyclovir Impurity E CAS NO 374697-95-7 is a specified impurity of the antiviral drug Acyclovir, critical for ensuring the safety and efficacy of the final pharmaceutical product. Its primary value lies in analytical and regulatory applications, where it is used as a certified reference standard for method development, validation, and quality control testing. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Acyclovir Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Critical component in analytical method development and validation for HPLC, UPLC, and other chromatographic techniques.
• Essential for pharmaceutical quality control (QC) and stability studies to monitor impurity profiles.
• Used in regulatory compliance and submission to agencies like the FDA and EMA, supporting ICH Q3A(R2) and Q3B(R2) guidelines.
• Supports research and development (R&D) for process optimization and impurity characterization in antiviral drug synthesis.

Basic Information

Product Name	Acyclovir Impurity E
CAS No.	374697-95-7
Molecular Formula	C8H11N5O3
Molecular Weight	225.21 g/mol
Synonyms	2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl acetate; 9-[(2-Acetoxyethoxy)methyl]guanine; Acyclovir Acetate Impurity; Acyclovir Related Compound E; Aciclovir Impurity E; 2-Acetoxyethoxymethylguanine; NSC 406087
EINECS	Contact for details

Quality Control

Our Acyclovir Impurity E is manufactured under strict quality management systems to ensure high purity and batch-to-batch consistency. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques. We support compliance with ICH guidelines and major pharmacopeias, ensuring the material is suitable for use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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