Description

Meloxicam Impurity 1 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the non-steroidal anti-inflammatory drug (NSAID) Meloxicam. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for impurity profiling, method development, and regulatory compliance testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Meloxicam active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity levels throughout the drug manufacturing process.
• Quality Control and Assurance (QC/QA): Serves as a system suitability standard in routine quality control laboratories to ensure the accuracy and precision of impurity assays.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Meloxicam to understand degradation pathways and establish shelf-life.
• Research and Development: Used in pharmaceutical R&D for studying the synthesis, metabolism, and degradation profile of Meloxicam.

Basic Information

Product Name	Meloxicam Impurity 1 Hcl
CAS No.	929568-25-2
Molecular Formula	C14H13N3O4S2 • HCl
Molecular Weight	387.86 g/mol (Free base: 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 hydrochloride; Meloxicam Related Compound A HCl; Meloxicam Impurity A Hydrochloride; 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylic acid (5-methyl-2-thiazolyl)amide 1,1-dioxide hydrochloride; UNII-9Z467FG2YK (hydrochloride salt); Meloxicam Hydrochloride Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Meloxicam Impurity 1 Hcl is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, assay results, and chromatographic data. Our quality processes are designed to support compliance with ICH Q3A/B guidelines and cGMP principles for impurities in new drug substances.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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