Description

Valaciclovir Impurity D CAS NO 1346747-69-0 is a high-purity chemical reference standard specifically identified as a process-related impurity of the antiviral drug Valaciclovir. This compound is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify Valaciclovir Impurity D in active pharmaceutical ingredient (API) batches and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency in Valaciclovir manufacturing.
• Regulatory Compliance and Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities as per ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Research and Development: Used in synthetic chemistry R&D to understand formation pathways and develop purification processes to minimize this impurity.

Basic Information

Product Name	Valaciclovir Impurity D
CAS No.	1346747-69-0
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 D; Valacyclovir Impurity D; Valaciclovir EP Impurity D; Valaciclovir USP Impurity D; L-Valine, ester with 9-[[2-(aminooxy)ethoxy]methyl]guanine; (S)-2-((2-((2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy)ethyl)amino)-3-methylbutanoic acid ethyl ester
EINECS	Contact for details

Quality Control

Our Valaciclovir Impurity D is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, 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. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) and relevant pharmacopeial guidelines (e.g., USP, EP).

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 Certificate of Analysis. The material may be hygroscopic; keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.