Description

Famciclovir Impurity 4 is a specified impurity and degradation product of the antiviral drug Famciclovir. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, purification, and quality assurance of Famciclovir and its related drug substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Famciclovir active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure drug substance and product meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability and shelf-life determination.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Process Chemistry Research: Aids in understanding and optimizing the Famciclovir synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Famciclovir Impurity 4
CAS No.	234110-22-6
Molecular Formula	C14H19N5O4
Molecular Weight	321.34 g/mol
Synonyms	Famciclovir Related Compound 4; 2-[(Acetyloxy)methyl]-4-(2-aminopurin-9-yl)butyl acetate; Penciclovir Diacetate Impurity; 9-[4-(Acetyloxy)-3-(acetoxymethyl)butyl]guanine; 2-Amino-9-[4-(acetyloxy)-3-(acetoxymethyl)butyl]-1,9-dihydro-6H-purin-6-one; Diacetyl Penciclovir; Penciclovir Diacetate; Famciclovir EP Impurity D
EINECS	Contact for details

Quality Control

Our Famciclovir Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) detailing all test results, ensuring compliance with ICH Q3A/B, USP, and EP guidelines for impurities. Our quality commitment supports your regulatory and research requirements with reliable and traceable reference materials.

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 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%
Residual Solvents (GC)	Complies with ICH Q3C

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