Description

Famciclovir Impurity 5 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiviral drug Famciclovir through rigorous quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Famciclovir active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Utilized in synthetic chemistry research to study the degradation pathways and metabolism of Famciclovir.
• Pharmacopeial Testing: Applied as a system suitability component in testing to meet USP, EP, or other pharmacopeia monograph requirements for Famciclovir.

Basic Information

Product Name	Famciclovir Impurity 5
CAS No.	183475-21-0
Molecular Formula	C14H19N5O4
Molecular Weight	321.34 g/mol
Synonyms	Famciclovir Related Compound 5; 2-[(Acetyloxy)methyl]-4-(2-aminopurin-9-yl)butyl acetate; Penciclovir Diacetate Impurity; 9-[4-(Acetyloxy)-2-(acetyloxymethyl)butyl]-9H-purin-2-amine; 2-Amino-9-[4-(acetyloxy)-2-(acetyloxymethyl)butyl]-1,9-dihydro-6H-purin-6-one (Tautomer); Diacetyl Penciclovir; Penciclovir Diacetate
EINECS	Contact for details

Quality Control

Every batch of Famciclovir Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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% w/w
Residue on Ignition	≤ 0.1%

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