Description

Amido Ethyl Meloxicam (Meloxicam Impurity) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Meloxicam. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies. The availability of a well-characterized impurity standard is essential for accurate quantification and control of related substances in drug substances and products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Meloxicam API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for purity analysis.
• Stability Studies: Employed to monitor the formation of degradation products in Meloxicam under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical QC laboratories to ensure impurity levels meet pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in metabolic studies and to understand the degradation pathways of Meloxicam.

Basic Information

Product Name	Amido Ethyl Meloxicam (Meloxicam Impurity)
CAS No.	881399-30-0
Molecular Formula	C16H14N4O4S
Molecular Weight	358.37 g/mol
Synonyms	4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide Ethyl Amide; Meloxicam Ethyl Amide Impurity; Meloxicam Related Compound; N-(5-Methyl-1,3-thiazol-2-yl)-4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide Ethyl Amide; Amidoethyl Meloxicam; AEM
EINECS	Contact for details

Quality Control

Our Amido Ethyl Meloxicam is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, which are aligned with ICH guidelines. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 ≤ 0.5%
Water Content (KF)	≤ 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.