Description

Ketoprofen Impurity 18 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 and validation. It is primarily used 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 Ketoprofen-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurities during drug manufacturing and stability studies.
• Quality Control & Assurance: Employed in routine QC testing to ensure Ketoprofen batches meet the purity specifications outlined in pharmacopeias (USP, EP, JP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish drug shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research for impurity profiling and the development of robust purification processes.

Basic Information

Product Name	Ketoprofen Impurity 18
CAS No.	144977-90-2
Molecular Formula	C16H14O3
Molecular Weight	254.28 g/mol
Synonyms	1-(3-Benzoylphenyl)ethyl acetate; Ketoprofen Impurity D; Ketoprofen Acetyl Impurity; Ketoprofen Related Compound D; 3-Acetyl Ketoprofen; [1-(3-Benzoylphenyl)ethyl] acetate; α-Acetoxy Ketoprofen; Ketoprofen EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Ketoprofen Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and residual solvents.

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 storing under an 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.