Description

Suxibuzone Impurity C is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Suxibuzone. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API). This impurity is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, testing, and compliance of Suxibuzone.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Suxibuzone Impurity C in drug substances and products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Suxibuzone API.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Suxibuzone meets pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity profiling.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Suxibuzone Impurity C
CAS No.	23111-33-3
Molecular Formula	C20H20N2O5S
Molecular Weight	400.45 g/mol
Synonyms	4-Butyl-1,2-diphenyl-3,5-pyrazolidinedione Impurity C; 1,2-Diphenyl-4-butyl-3,5-pyrazolidinedione Related Compound C; 4-Butyl-1,2-diphenylpyrazolidine-3,5-dione Impurity C; Suxibuzone Related Substance C; Suxibuzone EP Impurity C; Suxibuzone USP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Suxibuzone Impurity C is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality commitment aligns with cGMP principles for pharmaceutical reference standards. Comprehensive characterization is performed using techniques including HPLC, GC-MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific results against stringent specifications.

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 to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.