Description

Piroxicam Ep Impurity B Hcl is a high-purity chemical reference standard, specifically identified as an impurity of the non-steroidal anti-inflammatory drug (NSAID) Piroxicam. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug manufacturing. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories to ensure drug safety, efficacy, and compliance with stringent pharmacopoeial standards such as EP (European Pharmacopoeia) and USP.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify Piroxicam Ep Impurity B in active pharmaceutical ingredient (API) batches and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Piroxicam analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines and pharmacopoeia specifications.
• Stability Studies: Used to track the formation of this specific degradation impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over known and potential impurities in Piroxicam formulations.
• Research and Development: Facilitates research into the degradation pathways, synthesis, and toxicological profile of Piroxicam and its related substances.

Basic Information

Product Name	Piroxicam Ep Impurity B Hcl
CAS No.	97460-25-8
Molecular Formula	C15H13N3O4S • HCl
Molecular Weight	367.81 g/mol (Free base: 331.35)
Synonyms	4-Hydroxy-2-methyl-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide Hydrochloride; Piroxicam Impurity B (Hydrochloride); Piroxicam Related Compound B HCl; 1,2-Benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-N-2-pyridinyl-, 1,1-dioxide, hydrochloride; Piroxicam EP Impurity B; Piroxicam USP Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Piroxicam Ep Impurity B Hcl 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, NMR, and Mass Spectrometry to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP/GLP environments and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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