Description

Ketorolac Impurity A CAS NO 154476-25-2 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Ketorolac Tromethamine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ketorolac-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and GC methods to meet ICH Q2(R1) and other regulatory requirements.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure drug substance and product specifications are met.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2) guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), New Drug Applications (NDAs), and other regulatory documentation.
• Research & Development: Supports synthetic route optimization and process chemistry by identifying and controlling process-related impurities.

Basic Information

Product Name	Ketorolac Impurity A
CAS No.	154476-25-2
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; 1H-Pyrrolizine-1-carboxylic acid, 2,3-dihydro-5-benzoyl-; Ketorolac Related Compound A; Ketorolac Degradant; Ketorolac Tromethamine Impurity A; Ketorolac Acid Impurity; (RS)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Ketorolac Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods, including HPLC, GC, NMR, and MS. The quality management adheres to cGMP principles and supports compliance with ICH, USP, and EP monographs for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and stored in a desiccated environment away from direct light exposure to maintain long-term stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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