Description

Allopurinol Related Compound F is a high-purity chemical reference standard, identified by CAS No. 321571-07-7, which is critical for analytical and quality control processes in pharmaceutical development. This compound serves as a key impurity marker, essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient allopurinol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in allopurinol drug substance and finished products.
• Analytical Method Development and Validation: A critical component for developing, calibrating, and validating HPLC, UPLC, or GC analytical methods to meet ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and impurity levels.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH stability protocols.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development (R&D): Used in synthetic chemistry research to study metabolic pathways, degradation mechanisms, and to synthesize purer forms of allopurinol.

Basic Information

Product Name	Allopurinol Related Compound F
CAS No.	321571-07-7
Molecular Formula	C5H4N4O
Molecular Weight	136.11 g/mol
Synonyms	1H-Pyrazolo[3,4-d]pyrimidin-4(5H)-one, 1,5-dihydro-; Allopurinol Impurity F; Allopurinol EP Impurity F; Allopurinol Related Substance F; 1,5-Dihydro-1H-pyrazolo[3,4-d]pyrimidin-4-one; Allopurinol Degradant; Allopurinol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Allopurinol Related Compound F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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