Description

Meloxicam Ep Impurity D CAS NO 1331636-17-9 is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Meloxicam, as defined by the European Pharmacopoeia (EP) standards. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is an essential material for research scientists, analytical chemists, and quality assurance professionals in the pharmaceutical industry who require reliable and well-characterized impurities to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Meloxicam EP Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity profiles and ensure batches of Meloxicam comply with EP, USP, or other pharmacopoeial specifications.
• Stability Studies: Employed to identify and track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity characterization.
• Research & Development: Supports impurity profiling, synthesis pathway optimization, and degradation mechanism studies during the drug development process.

Basic Information

Product Name	Meloxicam EP Impurity D
CAS No.	1331636-17-9
Molecular Formula	C14H13N3O4S2
Molecular Weight	351.40 g/mol
Synonyms	4-Hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide; Meloxicam Impurity D (EP); Meloxicam Related Compound D; 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylic acid (5-methyl-2-thiazolyl)amide 1,1-dioxide; Meloxicam Sulfoxide; Meloxicam EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Meloxicam EP Impurity D is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity, purity, and assay testing using validated analytical methods such as HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopoeial guidelines.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Meloxicam (HPLC)	≤ 0.5%
Other Single Impurity (HPLC)	≤ 0.2%
Total Impurities (HPLC)	≤ 2.0%
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.