Description

Famciclovir Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the antiviral active pharmaceutical ingredient (API) Famciclovir. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of antiviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Famciclovir API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Famciclovir under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic route optimization and process chemistry studies by identifying and controlling process-related impurities.

Basic Information

Product Name	Famciclovir Impurity 7
CAS No.	127205-22-5
Molecular Formula	C14H19N5O4
Molecular Weight	321.34 g/mol
Synonyms	2-[(Acetyloxy)methyl]-4-(2-amino-9H-purin-9-yl)butyl acetate; Famciclovir Related Compound; 9-[4-(Acetoxymethyl)-2-(acetoxy)butyl]guanine; Penciclovir Diacetate; BRL 42810 Diacetate; Famciclovir Impurity B (in some references); 2,2'-Diacetoxymethyl-4-(2-aminopurin-9-yl)butane
EINECS	Contact for details

Quality Control

Our Famciclovir Impurity 7 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. Our quality commitment aligns with ICH guidelines and supports cGMP compliance for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.