Description

S, S-Isovalganciclovir Impurity is a specific stereoisomeric impurity associated with the antiviral drug Valganciclovir. This compound is of critical importance in the pharmaceutical industry for analytical research and quality control processes. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and ensuring the purity and safety of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Valganciclovir and its related substances.
• Impurity Profiling: Essential for identifying, characterizing, and quantifying this specific stereoisomer in drug substances and finished products to meet ICH Q3A and Q3B guidelines.
• Method Development & Validation: Serves as a critical component in developing and validating robust analytical methods, particularly for HPLC, UPLC, and LC-MS.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch testing to monitor and control impurity levels, ensuring consistent product quality and regulatory compliance.
• Stability Studies: Used to track the formation and level of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.

Basic Information

Product Name	S, S-Isovalganciclovir Impurity
CAS No.	1401562-13-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S)-2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-3-methylbutyl (2S)-2-amino-3-methylbutanoate; (S,S)-Isovalganciclovir; Valganciclovir Impurity (S,S-isomer); L-Valine, (2S)-2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-methylbutyl ester; Isovalganciclovir Stereoisomer
EINECS	Contact for details

Quality Control

Our S, S-Isovalganciclovir Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile, supporting compliance with ICH guidelines and cGMP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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