Description

Ketorolac Impurity 21 is a designated impurity 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 reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development, production, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ketorolac-related impurities in API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines for new drug substances and products.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the impurity profile of Ketorolac.
• Research and Development: Utilized in pharmaceutical R&D to understand degradation pathways and synthesis by-products of Ketorolac.

Basic Information

Product Name	Ketorolac Impurity 21
CAS No.	141054-42-4
Molecular Formula	C16H14ClNO3
Molecular Weight	303.74 g/mol
Synonyms	Ketorolac Related Compound 21; Ketorolac EP Impurity J; Ketorolac USP Impurity; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid Impurity; 1H-Pyrrolizine-1-carboxylic acid, 2,3-dihydro-5-benzoyl-, (S)-; (S)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid (Ketorolac) Impurity
EINECS	Contact for details

Quality Control

Every batch of Ketorolac Impurity 21 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR 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 each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is light-sensitive (store away from light) and should be handled under inert conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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