Description

Valganciclovir n-Valyl Impurity is a key process-related impurity and reference standard used in the pharmaceutical development and quality control of the antiviral drug Valganciclovir. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by enabling accurate identification and quantification of this specific impurity. It is an essential material for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical manufacturing, particularly those focused on antiviral therapies and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the n-Valyl impurity in Valganciclovir API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure impurity levels are within specified limits as per pharmacopeial or internal specifications.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability studies of Valganciclovir.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over the manufacturing process and product quality.
• Process Chemistry Research: Used by R&D chemists to study and optimize the synthesis pathway of Valganciclovir to minimize the formation of this impurity.

Basic Information

Product Name	Valganciclovir n-Valyl Impurity
CAS No.	897937-73-4
Molecular Formula	C20H29N6O6
Molecular Weight	449.48 g/mol
Synonyms	L-Valine, N-[(1,3-dihydro-2-propoxy-6H-purin-6-ylidene)methyl]-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-methylbutyl ester; Valganciclovir Related Compound C; Valganciclovir EP Impurity C; Valganciclovir USP Related Compound C; (S)-2-((2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy)-3-methylbutyl (S)-2-amino-3-methylbutanoate; n-Valyl Valganciclovir; Valganciclovir n-Valyl Ester Impurity
EINECS	Contact for details

Quality Control

Our Valganciclovir n-Valyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and control of related substances, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the results against specifications. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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