Description

Zaltoprofen Impurity 3 (Zaltoprofen S-Oxide) is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Zaltoprofen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Zaltoprofen S-Oxide in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurities during stability testing.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Zaltoprofen API and formulations meet specified impurity limits as per ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this oxidative degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory dossiers for FDA, EMA, and other global health authorities by providing impurity characterization data.
• Research on Degradation Pathways: Facilitates studies into the metabolism and degradation mechanisms of Zaltoprofen.

Basic Information

Product Name	Zaltoprofen Impurity 3 (Zaltoprofen S-Oxide)
CAS No.	134085-79-3
Molecular Formula	C₁₇H₁₄O₄S
Molecular Weight	314.36 g/mol
Synonyms	Zaltoprofen S-Oxide; Zaltoprofen Sulfoxide; Zaltoprofen Related Compound 3; 2-(10,11-Dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid S-Oxide; 10,11-Dihydro-10-oxodibenzo[b,f]thiepin-2-propanoic acid 5-Oxide; Zaltoprofen Impurity C; Zaltoprofen EP Impurity C; Zaltoprofen Sulfoxide Impurity
EINECS	Contact for details

Quality Control

Every batch of Zaltoprofen Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake.

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%
Assay	95.0% - 105.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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