Description

Penciclovir Impurity A is a designated reference standard used in the analytical profiling and quality control of the antiviral drug Penciclovir. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a key marker for identification and quantification during manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on antiviral drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Penciclovir Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling and assay determination.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation and levels of this specific impurity in Penciclovir under various storage conditions over time.
• Research & Development: Serves as a critical tool in synthetic chemistry research to understand and control impurity formation during the Penciclovir manufacturing process.
• Pharmacopoeial Testing: Employed in testing to meet the specifications outlined in pharmacopoeias such as USP, EP, or BP for Penciclovir.

Basic Information

Product Name	Penciclovir Impurity A
CAS No.	100199-40-4
Molecular Formula	C10H15N5O3
Molecular Weight	253.26 g/mol
Synonyms	9-(4-Hydroxy-3-hydroxymethylbut-1-yl)guanine; 2-Amino-9-((4-hydroxy-3-(hydroxymethyl)butyl)-1H-purin-6(9H)-one; Penciclovir Related Compound A; Penciclovir EP Impurity A; Penciclovir USP Impurity A; Denavir Impurity A; PCV Impurity A
EINECS	Contact for details

Quality Control

Every batch of Penciclovir Impurity A is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality protocols are designed to support compliance with cGMP and relevant pharmacopoeial guidelines.

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

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 impurity ≤ 1.0%
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.