Description

Allopurinol Impurity C is a designated impurity of the active pharmaceutical ingredient Allopurinol, a key medication used in the treatment of gout and hyperuricemia. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug manufacturing. It is an essential material for analytical laboratories and pharmaceutical companies focused on ensuring product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Allopurinol and its related substances.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Allopurinol API and finished drug products meet stringent pharmacopeial (e.g., USP, EP, ICH) impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Allopurinol formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the API development process.

Basic Information

Product Name	Allopurinol Impurity C
CAS No.	1346604-13-4
Molecular Formula	C5H4N4O
Molecular Weight	136.11 g/mol
Synonyms	1H-Pyrazolo[3,4-d]pyrimidin-4(5H)-one, 1,5-dihydro-; Allopurinol Related Compound C; Allopurinol EP Impurity C; Allopurinol USP Related Compound C; 1,5-Dihydro-1H-pyrazolo[3,4-d]pyrimidin-4-one; Allopurinol Degradant
EINECS	Contact for details

Quality Control

Our Allopurinol Impurity C is manufactured and handled under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the results against established specifications. The material is suitable for use in applications requiring compliance with ICH Q3A/B, USP, and European Pharmacopoeia guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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