Description

Acyclovir Impurity C is a specified impurity and degradation product of the antiviral drug Acyclovir. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and ensuring the purity and safety of Acyclovir-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Acyclovir Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of degradation products in Acyclovir formulations.
• Quality Control & Batch Release: A critical component in the quality control process to ensure batches of Acyclovir meet pharmacopoeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Required for compiling regulatory documentation (e.g., Drug Master Files, Common Technical Documents) to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Used in research to study the chemical stability and degradation mechanisms of Acyclovir under various conditions.

Basic Information

Item	Details
Product Name	Acyclovir Impurity C
CAS No.	91702-61-3
Molecular Formula	C8H11N5O3
Molecular Weight	225.21 g/mol
Synonyms	9-[(2-Hydroxyethoxy)methyl]guanine; 2-Amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; Acyclovir Related Compound C; Acyclovir EP Impurity C; Acyclovir USP Related Compound C; Guanine, 9-[(2-hydroxyethoxy)methyl]-; ACV Impurity C
EINECS	Contact for details

Quality Control

Every batch of Acyclovir Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopoeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.