Description

Topiroxostat Impurity 11 is a specified impurity and degradation product of the active pharmaceutical ingredient Topiroxostat, a xanthine oxidase inhibitor used in the treatment of hyperuricemia and gout. This impurity is critical for pharmaceutical manufacturers to monitor and control during drug development and production to ensure final product safety, efficacy, and regulatory compliance. It is primarily required by analytical laboratories and pharmaceutical companies for use as a certified reference standard in method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard: Serves as a primary standard for the qualitative and quantitative analysis of Topiroxostat drug substance and finished products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to separate and quantify this specific impurity.
• Quality Control & Batch Release: Used in the routine QC testing of Topiroxostat Active Pharmaceutical Ingredient (API) and formulated drug products to ensure impurity levels are within ICH guidelines.
• Stability Studies: Employed to identify and track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Topiroxostat, aiding in process optimization and formulation stability.

Basic Information

Item	Detail
Product Name	Topiroxostat Impurity 11
CAS No.	1549944-65-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 11; Topiroxostat Degradant; 2-[(3,5-Cyano-4-isobutoxyphenyl)-1H-pyrazol-1-yl]acetic acid impurity; FUROXOL Impurity 11; UR-1102 Impurity 11; Topiroxostat Process Impurity; Topiroxostat Specified Impurity
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 11 is manufactured under strict quality control conditions suitable for use as a pharmaceutical reference standard. Each batch undergoes comprehensive analytical characterization, including identity confirmation by spectroscopic methods (e.g., NMR, MS) and purity determination by advanced chromatographic techniques (HPLC). A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results for identity, purity, and impurities. Our quality system is designed to support regulatory requirements for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches 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 guidelines

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