Description

Desmethyl Piroxicam (Piroxicam Impurity B) is a key pharmaceutical reference standard and impurity used in the development and quality control of the non-steroidal anti-inflammatory drug (NSAID) Piroxicam. This compound is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and control of related substances during manufacturing. It is primarily utilized by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and regulatory affairs teams to meet stringent pharmacopeial standards (e.g., USP, EP) and regulatory submission requirements.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material (CRM) for identifying and quantifying Piroxicam-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity assays.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products in Piroxicam under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Essential for preparing regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Pharmacopeial Testing: Used to perform tests as per United States Pharmacopeia (USP) and European Pharmacopoeia (EP) monographs for Piroxicam.
• Chemical Synthesis Research: Acts as an intermediate or reference compound in studies aimed at synthesizing novel Piroxicam analogs or understanding its metabolic pathways.

Basic Information

Product Name	Desmethyl Piroxicam (Piroxicam Impurity B)
CAS No.	65897-46-3
Molecular Formula	C14H11N3O4S
Molecular Weight	317.32 g/mol
Synonyms	4-Hydroxypiroxicam; Piroxicam Impurity B; Piroxicam Related Compound B; 4-Hydroxy-2-methyl-N-(2-pyridinyl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide; 4'-Hydroxypiroxicam; Desmethylpiroxicam; UNII-5XH6E6K0EI; Piroxicam EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Desmethyl Piroxicam is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, related substances analysis, and identity confirmation (IR, MS), to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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.