Description

Lornoxicam Impurity 34 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the non-steroidal anti-inflammatory drug (NSAID) Lornoxicam. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lornoxicam Impurity 34 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate sensitive HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure they remain within ICH (International Council for Harmonisation) guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Lornoxicam to understand degradation pathways and establish shelf life.
• 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 & Development: Used in synthetic chemistry research to study the formation, fate, and purge of this specific impurity during the Lornoxicam manufacturing process.

Basic Information

Product Name	Lornoxicam Impurity 34
CAS No.	868393-61-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lornoxicam Related Compound 34; Lornoxicam EP Impurity 34; Lornoxicam USP Impurity 34; 6-Chloro-4-hydroxy-2-methyl-N-(2-pyridinyl)-2H-thieno[2,3-e][1,2]thiazine-3-carboxamide 1,1-dioxide (related impurity); Lornoxicam Degradation Product; Lornoxicam Process Impurity; Chlortenoxicam Impurity
EINECS	Contact for details

Quality Control

Every batch of Lornoxicam Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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