Description

Famciclovir Impurity 7 is a specified impurity and a key chemical reference standard used in the analytical profiling of the antiviral drug Famciclovir. This compound is critical for pharmaceutical quality control, enabling manufacturers to ensure product purity, safety, and regulatory compliance. It is primarily required by analytical laboratories, research institutions, and pharmaceutical companies involved in the development, production, and quality assurance of antiviral medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Famciclovir Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of impurities over time under various environmental conditions.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize and characterize related compounds.

Basic Information

Product Name	Famciclovir Impurity 7
CAS No.	97845-72-2
Molecular Formula	C14H19N5O4
Molecular Weight	321.33 g/mol
Synonyms	2-[(Acetyloxy)methyl]-4-(2-amino-9H-purin-9-yl)butyl acetate; Famciclovir Related Compound B; 9-[4-(Acetoxymethyl)-2-(acetoxy)butyl]guanine; Penciclovir Diacetate; BRL 42810 Diacetate; 2,2'-[(2-Amino-1,9-dihydro-9H-purin-9-yl)methyl]trimethylene diacetate; Diacetyl Penciclovir
EINECS	Contact for details

Quality Control

Our Famciclovir Impurity 7 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Our quality standards align with ICH guidelines and support compliance with major pharmacopeias (USP, EP).

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 compound 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
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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