Description

Despyridyl Piroxicam (Piroxicam Impurity C) is a key impurity and reference standard used in the analytical profiling of the non-steroidal anti-inflammatory drug (NSAID) Piroxicam. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability testing for Piroxicam-based formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Piroxicam Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods for Piroxicam analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial limits (USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Serves as a tool for studying the chemical stability and degradation mechanisms of Piroxicam.

Basic Information

Item	Details
Product Name	Despyridyl Piroxicam (Piroxicam Impurity C)
CAS No.	24683-25-8
Molecular Formula	C13H11N3O4S
Molecular Weight	305.31 g/mol
Synonyms	Piroxicam Impurity C; Piroxicam Related Compound C; 4-Hydroxy-2-methyl-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide; Despyridyl Piroxicam; 2-Methyl-4-hydroxy-2H-1,2-benzothiazine-3-carboxylic acid 2-pyridylamide 1,1-dioxide; 1,2-Benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-N-2-pyridinyl-, 1,1-dioxide
EINECS	Contact for details

Quality Control

Our Despyridyl Piroxicam is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified purity grades and relevant pharmacopeial guidelines.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
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.