Description

Ketoprofen Impurity 56 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Ketoprofen. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ketoprofen API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure analytical procedures are performing as intended.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Ketoprofen.

Basic Information

Product Name	Ketoprofen Impurity 56
CAS No.	60566-76-9
Molecular Formula	C16H14O3
Molecular Weight	254.28 g/mol
Synonyms	1,3-Dihydro-1-(3-benzoylphenyl)-2H-indol-2-one; Ketoprofen Impurity F; Ketoprofen Related Compound F; 3-(2-Oxo-2,3-dihydro-1H-indol-1-yl)benzophenone; 1-(3-Benzoylphenyl)indolin-2-one; Benzophenone, 3-(2-oxo-2,3-dihydro-1H-indol-1-yl)-; 60566-76-9; Ketoprofen EP Impurity F
EINECS	Contact for details

Quality Control

Our Ketoprofen Impurity 56 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is thoroughly characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3B(R2) guidelines and pharmacopeial standards (USP, EP).

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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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