Description

Ketorolac Impurity 43 is a designated impurity reference standard used in the analytical profiling and quality control of the non-steroidal anti-inflammatory drug (NSAID) Ketorolac Tromethamine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical benchmark in HPLC and LC-MS analysis for the quantification of related substances in Ketorolac active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ketorolac Tromethamine API and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating chromatographic methods (HPLC, UPLC, LC-MS) in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels, ensuring batches meet stringent pharmacopeial (USP, EP) and internal specification limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data on impurity profiles for regulatory filings (e.g., ANDA, NDA, CMC documentation) to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Ketorolac, supporting formulation optimization and packaging selection.

Basic Information

Product Name	Ketorolac Impurity 43
CAS No.	141054-45-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketorolac Related Compound 43; Ketorolac Tromethamine Impurity 43; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid Impurity (Ketorolac); Ketorolac Degradation Product; Ketorolac Process-Related Impurity; (RS)-5-Benzoyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic Acid Impurity
EINECS	Contact for details

Quality Control

Our Ketorolac Impurity 43 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results, ensuring traceability and compliance with current Good Manufacturing Practices (cGMP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

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 inert conditions or in a desiccator to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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