Description

Topiroxostat Impurity 9 is a designated impurity reference standard used in the pharmaceutical development and quality control of Topiroxostat, a xanthine oxidase inhibitor. This high-purity compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient by enabling accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within pharmaceutical and biotechnology companies focused on metabolic disorder therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Topiroxostat Impurity 9 in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Topiroxostat API and drug products meet stringent pharmacopeial (e.g., ICH Q3A/B) and internal specification limits for impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Topiroxostat, enabling process optimization for impurity minimization.

Basic Information

Product Name	Topiroxostat Impurity 9
CAS No.	577778-82-6
Molecular Formula	C16H14N6O2
Molecular Weight	322.32 g/mol
Synonyms	2-[4-(Cyanoamino)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-4-methylbenzoic acid; 4-Methyl-2-[4-(ureido)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]benzoic acid (related isomer); Topiroxostat Related Compound 9; Topiroxostat EP Impurity I; Febuxostat Impurity (structural analog); UR-1102 Impurity; Pyrazolopyrimidine derivative impurity.
EINECS	Contact for details

Quality Control

Every batch of Topiroxostat Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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