Description

Ganciclovir Impurity 3 is a specified impurity of the antiviral drug Ganciclovir, identified by the CAS number 130914-77-1. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ganciclovir Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control the levels of this specific impurity, ensuring it remains within ICH (International Council for Harmonisation) guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity characterization.
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Ganciclovir.

Basic Information

Product Name	Ganciclovir Impurity 3
CAS No.	130914-77-1
Molecular Formula	C9H13N5O4
Molecular Weight	255.23 g/mol
Synonyms	9-[(1,3-Dihydroxy-2-propoxy)methyl]guanine; DHPG Impurity; Ganciclovir Related Compound C; 2-Amino-1,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6H-purin-6-one; NSC 38295; Acyclovir analog; Antiherpesvirus agent impurity
EINECS	Contact for details

Quality Control

Every batch of Ganciclovir Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment and is available upon request.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.