Description

Parecoxib Impurity H CAS NO 1708094-99-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Parecoxib Sodium by serving as a key marker for impurity profiling and control. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development and quality assurance. The availability of this well-characterized impurity supports compliance with stringent pharmacopeial guidelines for impurity identification and quantification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Parecoxib Impurity H in Parecoxib Sodium drug substance and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in quality control laboratories.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this specific impurity during long-term and accelerated stability testing of Parecoxib formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and justify specifications as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency and compliance with established specifications.
• Research & Development: Used in R&D to study the degradation pathways of Parecoxib and to synthesize and characterize related substances.

Basic Information

Product Name	Parecoxib Impurity H
CAS No.	1708094-99-8
Molecular Formula	C19H18N2O4S
Molecular Weight	370.42 g/mol
Synonyms	Parecoxib Related Compound H; 5-Methyl-3-phenyl-4-[(5-methyl-3-phenylisoxazol-4-yl)methanesulfonyl]isoxazole; 4-[(5-Methyl-3-phenyl-4-isoxazolyl)methanesulfonyl]-5-methyl-3-phenylisoxazole; Parecoxib Disulfide Impurity; Parecoxib Sulfone Dimer; SC 71998 Impurity H; Dynastat Impurity H
EINECS	Contact for details

Quality Control

Every batch of Parecoxib Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming the material's suitability for its intended use as a reference standard.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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