Description

Ketoprofen Impurity 15 is a high-purity chemical reference standard used in the analytical profiling of the non-steroidal anti-inflammatory drug (NSAID) Ketoprofen. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of related substances during drug manufacturing. It is an essential material for quality control laboratories, regulatory affairs, and analytical scientists working to ensure the safety, efficacy, and compliance of Ketoprofen-based pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Ketoprofen active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Research: Used in HPLC, UPLC, and GC methods for the identification and quantification of specific impurities to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA, PMDA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as a marker to monitor impurity profiles in Ketoprofen formulations under various stress conditions (e.g., heat, humidity, light) as per ICH stability guidelines.
• Process Chemistry & Development: Aids in the optimization of synthetic routes and purification processes by tracking the formation and clearance of this specific impurity.
• Pharmacopoeial Testing: Used to verify compendial methods and specifications outlined in pharmacopoeias such as USP, EP, or BP for Ketoprofen.

Basic Information

Product Name	Ketoprofen Impurity 15
CAS No.	1257296-76-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoprofen Related Compound 15; Ketoprofen EP Impurity J; Ketoprofen USP Impurity; 2-(3-Benzoylphenyl)propanoic Acid Impurity; Ketoprofen Degradation Product; Ketoprofen Process Impurity; Ketoprofen Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ketoprofen Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. 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 in a cool, dry place at a controlled room temperature (typically 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 solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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