Description

S, R-Isovalganciclovir Impurity is a defined stereoisomeric impurity associated with the antiviral drug Valganciclovir. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research institutions, quality control laboratories, and API manufacturers involved in the production and analysis of antiviral medications to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of the S,R-isomer in Valganciclovir Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this stereoisomeric impurity.

Basic Information

Product Name	S, R-Isovalganciclovir Impurity
CAS No.	1356932-18-7
Molecular Formula	C14H22N6O5
Molecular Weight	354.36 g/mol
Synonyms	(2S)-2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-3-hydroxy-4-(2-hydroxyethoxy)methyl-4-(isovaleryloxy)butyl ester; (S,R)-Isovalganciclovir; Valganciclovir Impurity (S,R-isomer); Valganciclovir Related Compound; L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxy-4-(2-hydroxyethoxy)methyl-4-(3-methylbutanoyloxy)butyl ester; Ganciclovir isovalerate ester impurity
EINECS	Contact for details

Quality Control

Our S, R-Isovalganciclovir Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is light-sensitive (store away from light). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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