Description

Tenoxicam Impurity E (2-Methylthieno[2,3-D]Isothiazol-3(2H)-One-1,1-Dioxide) is a high-purity chemical reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound serves as a specified impurity for the non-steroidal anti-inflammatory drug (NSAID) Tenoxicam, enabling accurate identification, quantification, and control during drug development and manufacturing. It is an essential material for research scientists, analytical chemists, and quality control laboratories focused on ensuring drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in Tenoxicam analysis.
• Method Development and Validation: Critical for developing, optimizing, and validating chromatographic methods to separate and quantify Tenoxicam and its related substances.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Tenoxicam Active Pharmaceutical Ingredient (API) and finished dosage forms to monitor impurity profiles against ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation of degradation products in Tenoxicam formulations under various stress conditions (heat, light, humidity).
• Research & Development (R&D): Facilitates studies on the synthesis pathways, degradation mechanisms, and toxicological profiles of Tenoxicam-related compounds.

Basic Information

Product Name	Tenoxicam Impurity E
CAS No.	94040-09-2
Molecular Formula	C7H5NO3S2
Molecular Weight	215.25 g/mol
Synonyms	2-Methylthieno[2,3-d]isothiazol-3(2H)-one 1,1-dioxide; Tenoxicam Related Compound E; Tenoxicam Impurity E; 2-Methyl-3-oxo-2,3-dihydrothieno[2,3-d]isothiazole 1,1-dioxide; Thieno[2,3-d]isothiazol-3(2H)-one, 2-methyl-, 1,1-dioxide; Tenoxicam EP Impurity E; Tenoxicam USP Impurity E
EINECS	Contact for details

Quality Control

Every batch of Tenoxicam Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive and should be handled accordingly to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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