Description

Valaciclovir Ep Impurity C is a designated impurity standard used in the pharmaceutical development and quality control of Valaciclovir, an antiviral prodrug. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Valaciclovir API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor and control impurity levels.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to identify and track the formation of this specific impurity over time.
• Quality Control & Batch Release Testing: A critical component in the QC testing protocol to ensure every batch of Valaciclovir meets stringent pharmacopeial (e.g., EP, USP) specifications for impurity limits.
• Regulatory Documentation & Submission: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Valaciclovir.

Basic Information

Product Name	Valaciclovir Ep Impurity C
CAS No.	1346747-65-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Valine, 2-[[2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl]amino]-, ethyl ester; Valaciclovir Related Compound C; Valacyclovir Impurity C; Valaciclovir Impurity C (EP); Valaciclovir Process Impurity C
EINECS	Contact for details

Quality Control

Our Valaciclovir Ep Impurity C is manufactured and tested under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR, MS), 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 specified requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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