Description

Ketorolac Impurity 31 is a designated impurity standard of the non-steroidal anti-inflammatory drug (NSAID) Ketorolac Tromethamine. This compound is critical for ensuring the safety and efficacy of the final pharmaceutical product by enabling accurate identification, quantification, and control during the manufacturing process. It is an essential reference material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on analytical method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Ketorolac Tromethamine drug substance and drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor and control impurity levels, ensuring batches meet specified International Council for Harmonisation (ICH) guidelines.
• Regulatory Submission & Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Pharmacopeial Testing: Supports testing to meet the requirements of pharmacopeias such as USP, EP, or BP where specified.

Basic Information

Product Name	Ketorolac Impurity 31
CAS No.	144710-35-0
Molecular Formula	C16H14ClNO3
Molecular Weight	303.74 g/mol
Synonyms	Ketorolac Related Compound; Ketorolac Tromethamine Impurity 31; 5-Benzoyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic Acid Impurity; (RS)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid Impurity; Ketorolac EP Impurity; Ketorolac USP Impurity; Ketorolac Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ketorolac Impurity 31 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in methods validated to USP/EP monographs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	95.0% - 105.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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