Description

Parecoxib Sodium Impurity 14 is a designated impurity of the active pharmaceutical ingredient (API) Parecoxib Sodium, a selective COX-2 inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Parecoxib Sodium drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Parecoxib Sodium API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Parecoxib Sodium.
• Regulatory Submissions: Provides necessary impurity characterization 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 API synthesis, helping to optimize manufacturing processes for higher purity.

Basic Information

Product Name	Parecoxib Sodium Impurity 14
CAS No.	1709956-89-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Parecoxib Related Compound 14; Parecoxib Sodium EP Impurity 14; Parecoxib Sodium USP Impurity 14; Parecoxib Impurity 14; 5-Fluoro-2-methyl-1-[4-(methylsulfonyl)phenyl]-1H-pyrrole-3-acetic acid impurity (related to Parecoxib); Valdecoxib Impurity (related to Parecoxib synthesis); SC-69124 Impurity; COX-2 Inhibitor Impurity.
EINECS	Contact for details

Quality Control

Our Parecoxib Sodium Impurity 14 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability with a Certificate of Analysis (COA) that includes batch number, expiration date, and detailed test results. Our quality standards align with ICH guidelines and support compliance requirements for cGMP manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.