Description

Tenoxicam Impurity D (n-Methyl-N'-(2-Pyridyl)Oxamide) is a key chemical reference standard used for the identification and quantification of related substances in the active pharmaceutical ingredient Tenoxicam. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by providing a benchmark for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in the development and production of non-steroidal anti-inflammatory drugs (NSAIDs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Tenoxicam API and its finished dosage forms.
• Analytical Method Development: Used to develop, validate, and calibrate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Tenoxicam under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Tenoxicam.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Tenoxicam Impurity D
CAS No.	52781-01-8
Molecular Formula	C9H11N3O2
Molecular Weight	193.20 g/mol
Synonyms	n-Methyl-N'-(2-Pyridyl)Oxamide; N-Methyl-N'-(pyridin-2-yl)oxalamide; Oxamide, N-methyl-N'-2-pyridinyl-; Tenoxicam Related Compound D; Tenoxicam Impurity 4; 2-(Methylcarbamoyl)-N-(pyridin-2-yl)oxamide; UNII-0K2I8VJ9VH
EINECS	Contact for details

Quality Control

Every batch of Tenoxicam Impurity D is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.