Description

Famciclovir Impurity 12 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiviral drug Famciclovir during its development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies involved in research, quality assurance, and compliance testing.

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 to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Employed in routine quality control testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions to establish product shelf life.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Famciclovir, helping to refine manufacturing processes.

Basic Information

Product Name	Famciclovir Impurity 12
CAS No.	122497-20-5
Molecular Formula	C14H19N5O4
Molecular Weight	321.34 g/mol
Synonyms	Famciclovir Related Compound 12; 2-[(Acetyloxy)methyl]-4-(2-aminopurin-9-yl)butyl acetate; Penciclovir Diacetate Impurity; 9-[4-(Acetyloxy)-3-(acetoxymethyl)butyl]-9H-purin-2-amine; 2-Amino-9-[4-(acetyloxy)-3-(acetoxymethyl)butyl]-1,9-dihydro-6H-purin-6-one (alternative representation); Diacetyl Penciclovir; Penciclovir Diacetate; Famciclovir Impurity D (Potential designation)
EINECS	Contact for details

Quality Control

Our Famciclovir Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
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% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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