Description

Famciclovir N7-Isomer CAS NO 131266-15-4 is a specific stereoisomer of the antiviral prodrug Famciclovir, representing a critical reference standard and intermediate in pharmaceutical research and development. This compound is essential for analytical method development, impurity profiling, and ensuring the quality and safety of active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development, quality control, and regulatory submission of antiviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the N7-isomer impurity in Famciclovir API and finished dosage forms.
• Impurity Profiling & Method Development: Critical for developing and validating analytical methods (e.g., HPLC, LC-MS) to monitor and control process-related impurities.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Process Chemistry Research: Serves as a key intermediate or marker in studying and optimizing the synthesis pathway of Famciclovir to minimize isomer formation.
• Quality Control (QC) Testing: Employed in routine QC laboratories to confirm the identity and purity of Famciclovir batches against known impurity standards.
• Stability Studies: Used to assess the degradation profile of Famciclovir under various stress conditions.

Basic Information

Product Name	Famciclovir N7-Isomer
CAS No.	131266-15-4
Molecular Formula	C14H19N5O4
Molecular Weight	321.33 g/mol
Synonyms	Famciclovir Impurity C; Famciclovir Related Compound C; 2-[(Acetyloxy)methyl]-4-(2-aminopurin-9-yl)butyl acetate; 9-(4-Acetoxy-3-acetoxymethylbut-1-yl)-2-aminopurine; BRL 42810 N7-Isomer; N7-Famciclovir
EINECS	Contact for details

Quality Control

Our Famciclovir N7-Isomer is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications tailored for use as a reference standard. We support compliance with ICH guidelines Q3A(R2) and Q3B(R2) for impurities in new drug substances and products.

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 must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.