Description

Aciclovir Imp. H (Ep) is a high-purity reference standard and pharmaceutical intermediate, specifically identified as an impurity of the antiviral drug Aciclovir. This compound is critical for ensuring the quality, safety, and efficacy of Aciclovir-based pharmaceutical formulations through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development and production of antiviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity H in Aciclovir drug substance and finished products, ensuring compliance with pharmacopoeial monographs (EP, USP).
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Quality Control & Stability Studies: Employed in routine batch release testing and forced degradation studies to monitor impurity levels and assess drug stability over time.
• Regulatory Submissions: Essential for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways of Aciclovir and to develop improved synthetic processes with lower impurity burdens.

Basic Information

Product Name	Aciclovir Imp. H (Ep)
CAS No.	133186-23-9
Molecular Formula	C8H11N5O3
Molecular Weight	225.21 g/mol
Synonyms	Aciclovir Impurity H; Acyclovir Impurity H; 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl acetate; 9-[(2-Acetoxyethoxy)methyl]guanine; Acyclovir EP Impurity H; Aciclovir Related Compound H
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured and controlled to meet the stringent requirements of the European Pharmacopoeia (EP) monograph. Every batch is subjected to comprehensive analytical testing, including HPLC purity assay, related substances analysis, and confirmatory identification tests. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results, chromatograms, and traceability information to ensure full compliance for GMP applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities: ≤ 2.0% Any individual impurity: ≤ 0.5%
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.