Description

Ketorolac Impurity 54 is a designated 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 ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Primary application as a certified impurity standard for the identification and quantification of related substances in Ketorolac Tromethamine API and its formulations.
• Analytical Method Development: Used in developing and validating High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B guidelines) for impurities.
• Stability Studies: Employed to monitor the formation of degradation products in Ketorolac drug products under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Research & Development: Utilized in synthetic chemistry research to study the degradation pathways and metabolism of Ketorolac.

Basic Information

Product Name	Ketorolac Impurity 54
CAS No.	113502-54-8
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	Ketorolac Related Compound 54; Ketorolac Tromethamine Impurity 54; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; 1H-Pyrrolizine-1-carboxylic acid, 5-benzoyl-2,3-dihydro-; Ketorolac Acid Impurity; Ketorolac Degradation Product; Ketorolac Process Impurity
EINECS	Contact for details

Quality Control

Our Ketorolac Impurity 54 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, identity confirmation (IR, NMR), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term stability, it is recommended to store the material under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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