Description

Aciclovir Impurity O is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiviral drug Aciclovir by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of antiviral medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Aciclovir Impurity O in drug substances and products.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor impurity levels in Aciclovir formulations under various storage conditions over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research and Development: Used in synthetic chemistry and process development to understand and control impurity formation pathways.

Basic Information

Product Name	Aciclovir Impurity O
CAS No.	2190509-40-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aciclovir Related Compound O; Acyclovir Impurity O; 9-[(2-Hydroxyethoxy)methyl]guanine Impurity O; 2-Amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one Impurity O; NSC 406087 Impurity O; Zovirax Impurity O
EINECS	Contact for details

Quality Control

Our Aciclovir Impurity O is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming identity, purity, and strength. Our quality standards align with ICH guidelines for impurities in new drug substances.

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 must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w

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