Description

Ganciclovir Impurity D is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for ensuring the safety and efficacy of the antiviral drug Ganciclovir by accurately identifying and quantifying this specific impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality assurance, and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ganciclovir Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling of Ganciclovir.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing to ensure drug purity meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data required for drug approval.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Ganciclovir formulations.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for the API.

Basic Information

Product Name	Ganciclovir Impurity D
CAS No.	1346598-14-8
Molecular Formula	C9H13N5O4
Molecular Weight	255.23 g/mol
Synonyms	9-[(1,3-Dihydroxy-2-propoxy)methyl]guanine; DHPG Impurity D; 2-Amino-1,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6H-purin-6-one; Ganciclovir Related Compound D; GCV Impurity D; (2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy-1,3-propanediol
EINECS	Contact for details

Quality Control

Our Ganciclovir Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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