Description

Acyclovir Impurity I: 7,9'-[Ethylene-Bis(Oxymethylene)] Bis (2-Amino-1-9-Dihydro-6H-Purin-6-One) is a critical reference standard used for the identification, qualification, and quantification of a key process-related impurity in the antiviral drug Acyclovir. This high-purity compound is essential for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories, quality control departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the analysis of Acyclovir drug substance and finished dosage forms.
• Method Development and Validation: Used to establish and validate analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity identification and specification setting as per ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability testing of Acyclovir.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing.
• Research and Development: Utilized in synthetic chemistry research to study impurity formation pathways and to develop purer synthesis routes for Acyclovir.

Basic Information

Product Name	Acyclovir Impurity I: 7,9'-[Ethylene-Bis(Oxymethylene)] Bis (2-Amino-1-9-Dihydro-6H-Purin-6-One)
CAS No.	1797832-75-7
Molecular Formula	C₁₄H₁₆N₁₀O₄
Molecular Weight	388.34 g/mol
Synonyms	Acyclovir Impurity I; Acyclovir Related Compound I; 7,9'-[Ethylene-Bis(Oxymethylene)]bis(guanine); 2,2'-[1,2-Ethanediylbis(oxy)]bis[9H-purin-6-amine]; 7,9'-(Ethylenebis(oxymethylene))bis(2-amino-1,9-dihydro-6H-purin-6-one); Acyclovir Dimer Impurity; Acyclovir Ethylene Dimer; Bis(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxyethane
EINECS	Contact for details

Quality Control

Our Acyclovir Impurity I is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) providing full characterization data, including purity by HPLC, identity confirmation by spectroscopic methods (IR, NMR, MS), and impurity profile. We support compliance with ICH, USP, and EP guidelines, and specifications can be aligned with client-specific pharmacopeial or internal method requirements.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.