Description

Isopropyl 4-Hydroxy-2H-1,2-Benzothiazine-3-Carboxylate 1,1-Dioxide (Piroxicam Impurity I) is a critical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Piroxicam. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific impurity, ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily utilized in research and development, method validation, and routine quality assurance testing within the pharmaceutical industry.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Piroxicam Impurity I in API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for Piroxicam analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopoeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Piroxicam.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Used in synthetic chemistry research to study the formation and mitigation of this impurity during the Piroxicam manufacturing process.

Basic Information

Product Name	Isopropyl 4-Hydroxy-2H-1,2-Benzothiazine-3-Carboxylate 1,1-Dioxide (Piroxicam Impurity I)
CAS No.	76508-35-5
Molecular Formula	C15H17NO5S
Molecular Weight	323.36 g/mol
Synonyms	Piroxicam Impurity I; Piroxicam Related Compound I; 4-Hydroxy-2-methyl-1,1-dioxo-N-(2-pyridyl)-2H-1,2-benzothiazine-3-carboxamide Isopropyl Ester Impurity; Isopropyl 4-Hydroxy-2-methyl-1,1-dioxo-1,2-dihydro-1λ6,2-benzothiazine-3-carboxylate; Felden Impurity I; CP-16171 Impurity
EINECS	Contact for details

Quality Control

Our high-purity reference standards are manufactured and tested under strict quality systems. Each batch of Isopropyl 4-Hydroxy-2H-1,2-Benzothiazine-3-Carboxylate 1,1-Dioxide (Piroxicam Impurity I) undergoes rigorous analytical characterization using techniques such as HPLC, NMR, and Mass Spectrometry to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results, ensuring traceability and compliance with ICH Q3B(R2) guidelines and relevant pharmacopoeial standards for impurity control.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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