Description

Ketoprofen Impurity 8 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 (API) Ketoprofen. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical 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 & Validation: 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 & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light).
• Research & Development: Used in pharmaceutical R&D to study degradation pathways, synthesis processes, and the chemical behavior of Ketoprofen.

Basic Information

Item	Details
Product Name	Ketoprofen Impurity 8
CAS No.	167300-68-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoprofen Related Compound 8; Ketoprofen Impurity C; Ketoprofen EP Impurity C; 2-(3-Benzoylphenyl)propanoic Acid Impurity; 3-Carboxybenzophenone Impurity; Ketoprofen Process Impurity; Degradation Product of Ketoprofen
EINECS	Contact for details

Quality Control

Our Ketoprofen Impurity 8 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS) and purity assessment by chromatographic techniques (HPLC, GC). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results, ensuring traceability and compliance with current industry standards for reference materials.

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 must be kept under dry conditions 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 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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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