Description

Lornoxicam Impurity 9 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Lornoxicam. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control testing. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Lornoxicam-based pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lornoxicam Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability-indicating assays.
• Quality Control & Batch Release: Acts as a system suitability and identification standard in routine QC testing to ensure API and drug product batches meet stringent purity specifications.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Facilitates studies to understand the chemical degradation mechanisms of Lornoxicam, aiding in the formulation of more stable drug products.

Basic Information

Product Name	Lornoxicam Impurity 9
CAS No.	70374-36-6
Molecular Formula	C13H10ClN3O4S2
Molecular Weight	371.82 g/mol
Synonyms	6-Chloro-4-hydroxy-2-methyl-N-2-pyridinyl-2H-thieno[2,3-e][1,2]thiazine-3-carboxamide 1,1-Dioxide; Lornoxicam Related Compound 9; Lornoxicam Degradant; Lornoxicam Process Impurity; Chlortenoxicam Impurity; Ro 13-9297 Impurity; (6-Chloro-4-hydroxy-2-methyl-1,1-dioxo-1λ⁶,2-dihydrothieno[2,3-e][1,2]thiazin-3-yl)(pyridin-2-yl)methanone
EINECS	Contact for details

Quality Control

Every batch of Lornoxicam Impurity 9 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identification (IR/UV), residual solvents, and loss on drying. Our quality commitment supports compliance with ICH guidelines and relevant pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use and inert atmosphere.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Loss on Drying	≤ 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.