Description

Ganciclovir Ep Impurity A is a specified impurity and reference standard used in the quality control of the antiviral drug Ganciclovir. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily required by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ganciclovir Ep Impurity A in Ganciclovir Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity profiles and ensure batches meet pharmacopoeial specifications (e.g., USP, EP, BP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (forced degradation studies) as per ICH Q1A(R2).
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry by identifying and quantifying this impurity during API development.

Basic Information

Product Name	Ganciclovir Ep Impurity A
CAS No.	1797982-93-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ganciclovir Impurity A; Ganciclovir Related Compound A; Ganciclovir EP Impurity A; Ganciclovir European Pharmacopoeia Impurity A; 2-Amino-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-1,9-dihydro-6H-purin-6-one Impurity; GCV Impurity A; (2-Amino-1,9-dihydro-9-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl]-6H-purin-6-one) Impurity A
EINECS	Contact for details

Quality Control

Our Ganciclovir Ep Impurity A is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.