Description

Ketoprofen Impurity 11 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Ketoprofen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, contract research organizations (CROs), and regulatory bodies involved in ensuring the purity, safety, and efficacy of Ketoprofen API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ketoprofen active pharmaceutical ingredient (API).
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing of Ketoprofen batches to ensure they meet pharmacopoeial standards (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Pathways: Facilitates studies to understand the chemical degradation mechanisms of Ketoprofen.

Basic Information

Product Name	Ketoprofen Impurity 11
CAS No.	144977-91-3
Molecular Formula	C16H14O3
Molecular Weight	254.28 g/mol
Synonyms	Ketoprofen Related Compound B; Ketoprofen EP Impurity B; 3-Benzoyl-α-methylbenzenepropanoic Acid Impurity; 2-(3-Benzoylphenyl)propanoic Acid Impurity; Ketoprofen Degradation Product; Ketoprofen Process Impurity; (RS)-2-(3-Benzoylphenyl)propanoic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Ketoprofen Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopoeial 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 (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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