Description

Topiroxostat Impurity 21 is a designated impurity standard of the active pharmaceutical ingredient Topiroxostat, a xanthine oxidase inhibitor. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) to ensure the safety, efficacy, and regulatory compliance of drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Topiroxostat Impurity 21 in drug substance and drug product analysis.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Serves as a system suitability standard and for preparing calibration curves in routine QC testing to ensure impurity levels are within ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data on impurity identity and qualification for regulatory filings (e.g., FDA, EMA) to support New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs).
• Process Chemistry Research: Used to identify and control the formation of this impurity during the synthesis and purification stages of Topiroxostat API manufacturing.

Basic Information

Product Name	Topiroxostat Impurity 21
CAS No.	2044704-74-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 21; Topiroxostat EP Impurity 21; Topiroxostat USP Impurity 21; 2-[(3,5-Dicyano-4-isobutoxyphenyl)methylthio]-4-methylpyrimidine-5-carboxylic acid (putative structure based on naming convention); FC-421 Impurity; UR-1102 Impurity 21
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 21 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), 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 to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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