Description

Ethyl 4-Hydroxy-2H-1,2-Benzothiazine-3-Carboxylate 1,1-Dioxide (Piroxicam Impurity H) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis of the non-steroidal anti-inflammatory drug (NSAID) Piroxicam, ensuring drug safety and regulatory compliance. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, where precise impurity profiling is mandatory.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Piroxicam Impurity H in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical component in developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Piroxicam API.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies of Piroxicam to understand degradation pathways and establish shelf-life.
• Research and Development: Used in synthetic chemistry research to study the formation, fate, and purge of this specific impurity during API synthesis.

Basic Information

Product Name	Ethyl 4-Hydroxy-2H-1,2-Benzothiazine-3-Carboxylate 1,1-Dioxide (Piroxicam Impurity H)
CAS No.	24683-21-4
Molecular Formula	C₁₂H₁₁NO₅S
Molecular Weight	281.28 g/mol
Synonyms	Piroxicam Impurity H; Piroxicam Related Compound H; Ethyl 4-Hydroxy-1,2-benzothiazine-3-carboxylate 1,1-Dioxide; 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylic Acid Ethyl Ester 1,1-Dioxide; 1,2-Benzothiazine-3-carboxylic Acid, 4-Hydroxy-, Ethyl Ester, 1,1-Dioxide; Piroxicam EP Impurity H; Piroxicam USP Impurity H
EINECS	Contact for details

Quality Control

Our Ethyl 4-Hydroxy-2H-1,2-Benzothiazine-3-Carboxylate 1,1-Dioxide (Piroxicam Impurity H) is manufactured under strict quality systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide Certificates of Analysis (COA) with detailed chromatographic data, including retention time and relative response factor where applicable, to support its use as a reference standard. The material is suitable for use in methods compliant with USP, EP, and ICH guidelines.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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