Description

Ketoprofen Ep Impurity J 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 in analytical method development and validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory affairs professionals to ensure drug purity, safety, and compliance with stringent pharmacopeial guidelines such as EP and USP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ketoprofen-related impurities in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug stability studies.
• Quality Control & Assurance: Employed in routine QC testing to ensure Ketoprofen API and formulations meet the specified impurity limits as per ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., CMC sections of ANDA, NDA) by providing necessary impurity characterization data to agencies like the FDA and EMA.
• Stability Studies: Acts as a marker to study degradation pathways and establish the shelf-life of Ketoprofen-based pharmaceutical products.
• Research & Development: Utilized in pharmaceutical R&D for impurity synthesis, isolation studies, and understanding the chemical behavior of Ketoprofen.

Basic Information

Product Name	Ketoprofen Ep Impurity J
CAS No.	1785759-59-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoprofen Impurity J; Ketoprofen EP Impurity J; Ketoprofen Related Compound J; 2-(3-Benzoylphenyl)propanoic acid impurity J; Ketoprofen Degradation Product J; Ketoprofen Process Impurity J; Ketoprofen Specified Impurity J
EINECS	Contact for details

Quality Control

Our Ketoprofen Ep Impurity J is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with the requirements for pharmaceutical reference materials.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Assay (HPLC)	95.0% - 105.0%

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