Description

Amido Methyl Meloxicam is a key process-related impurity of the non-steroidal anti-inflammatory drug (NSAID) Meloxicam. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Meloxicam API and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Meloxicam Active Pharmaceutical Ingredient (API).
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine batch testing within pharmaceutical QC labs to ensure compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing the Meloxicam synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Amido Methyl Meloxicam (Meloxicam Impurity)
CAS No.	892395-41-4
Molecular Formula	C15H13N3O5S
Molecular Weight	347.35 g/mol
Synonyms	Meloxicam Amido Methyl Impurity; Meloxicam Impurity F; 4-Hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide; Methyl Amido Meloxicam; Meloxicam Related Compound F; UNII-9P6K5P8H4T; Amido Methyl Derivative of Meloxicam
EINECS	Contact for details

Quality Control

Every batch of Amido Methyl Meloxicam is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting 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. The product is light-sensitive and should be handled accordingly to maintain stability.

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%
Meloxicam (HPLC)	≤ 0.5%
Single Unknown Impurity (HPLC)	≤ 0.2%
Total Impurities (HPLC)	≤ 2.0%
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.