Description

Valaciclovir Ep Impurity H is a critical pharmaceutical reference standard and impurity used in the quality control of antiviral drug manufacturing. This compound is essential for ensuring the purity, safety, and efficacy of Valaciclovir and related prodrugs by serving as a key marker in analytical methods. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the development and production of antiviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Valaciclovir Ep Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Critical for developing, validating, and transferring analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, in compliance with ICH guidelines.
• Quality Control & Stability Studies: Employed in routine QC testing and stability-indicating assays to monitor impurity profiles and ensure product consistency throughout its shelf life.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data and specifications for drug master files (DMFs).
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity during Valaciclovir synthesis.
• Pharmacopoeial Testing: Used for testing against monographs in pharmacopoeias such as the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).

Basic Information

Product Name	Valaciclovir Ep Impurity H
CAS No.	84499-64-9
Molecular Formula	C13H20N6O4
Molecular Weight	324.34 g/mol
Synonyms	L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester; 9-[[2-[(1-Carboxy-2-methylpropyl)amino]ethoxy]methyl]guanine; Valacyclovir Impurity H; Valaciclovir Related Compound H; VACV Impurity H; L-Valine 2-((2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)ethyl ester; Acyclovir L-valyl ester impurity
EINECS	Contact for details

Quality Control

Our Valaciclovir Ep Impurity H is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical analysis. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data from HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities. Certificates of Analysis are 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%

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