Description

Parecoxib Sodium Impurity H CAS NO 501093-49-8 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Parecoxib Sodium by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D and production. The standard supports compliance with stringent regulatory guidelines for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Impurity H in Parecoxib Sodium API and finished drug products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance and Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of Impurity H over time under various stress conditions to establish product shelf-life.
• Research and Development: Facilitates process chemistry optimization by helping to understand and control the formation of this specific degradation product.

Basic Information

Product Name	Parecoxib Sodium Impurity H
CAS No.	501093-49-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Parecoxib Related Compound H; Parecoxib Impurity H; Dexparecoxib Impurity H; Valdecoxib Impurity; 4-(5-Methyl-3-phenyl-4-isoxazolyl)benzenesulfonamide Related Substance H; SC 70935 Impurity H; COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Sodium Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profile as determined by advanced chromatographic techniques.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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