Description

Celecoxib Impurity 43 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Celecoxib through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Celecoxib API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for impurity monitoring.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure impurity levels remain within ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing definitive identification and characterization of a specified impurity.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Utilized in synthetic chemistry R&D to understand impurity formation pathways and to develop robust purification processes for Celecoxib.

Basic Information

Product Name	Celecoxib Impurity 43
CAS No.	131430-27-8
Molecular Formula	C17H14F3N3O2S
Molecular Weight	381.37 g/mol
Synonyms	4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Impurity 43; Celecoxib Related Compound 43; Celecoxib EP Impurity C; Celecoxib USP Related Substance; 1-[4-(Aminosulfonyl)phenyl]-5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole; Celecoxib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Celecoxib Impurity 43 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with relevant specifications.

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 desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.