Description

Ketorolac Ep Impurity D is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the non-steroidal anti-inflammatory drug (NSAID) Ketorolac Tromethamine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ketorolac Tromethamine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH guidelines (Q3A, Q3B).
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific degradation product under various stress conditions.
• Pharmacopoeial Testing: Used in testing to meet the specifications outlined in pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Research & Development: Supports R&D activities focused on understanding the degradation pathways and chemistry of Ketorolac.

Basic Information

Product Name	Ketorolac Ep Impurity D
CAS No.	1391053-45-4
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	Ketorolac Impurity D; Ketorolac Related Compound D; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; (1RS)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; Ketorolac Acid Impurity; Ketorolac Degradation Product; Ketorolac Tromethamine Impurity D
EINECS	Contact for details

Quality Control

Every batch of Ketorolac Ep Impurity D is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure compliance with pharmacopoeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile 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. Keep the container in a dry, cool, and well-ventilated place.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.