Description

Ketoprofen Impurity 19 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the non-steroidal anti-inflammatory drug (NSAID) Ketoprofen. It is essential for researchers and quality assurance professionals in pharmaceutical manufacturing and analytical laboratories who require reliable impurity standards to ensure drug safety, efficacy, and regulatory compliance.

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) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing, optimizing, and validating HPLC, UPLC, and GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity characterization reports required by FDA, EMA, and other global health authorities.
• Stability Studies: Employed to track the formation of degradation products in Ketoprofen formulations under various stress conditions (heat, light, humidity).
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of Ketoprofen and related compounds.

Basic Information

Product Name	Ketoprofen Impurity 19
CAS No.	1420774-68-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoprofen Related Compound 19; Ketoprofen EP Impurity 19; Ketoprofen USP Impurity 19; 2-(3-Benzoylphenyl)propanoic acid impurity 19; Ketoprofen Degradation Product 19; Ketoprofen Process Impurity 19; (RS)-2-(3-Benzoylphenyl)propanoic acid impurity
EINECS	Contact for details

Quality Control

Every batch of Ketoprofen Impurity 19 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. 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 at controlled room temperature (15-25°C) or as indicated on the product label or COA. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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