Description

Ketorolac Ep Impurity H is a critical pharmaceutical reference standard and impurity used in the analytical profiling of Ketorolac Tromethamine. This compound is essential for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods for Ketorolac Tromethamine.
• Impurity Profiling & Control: Used in the identification, qualification, and quantification of related substances during drug substance and drug product development.
• Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for stability-indicating assays.
• Quality Assurance & Compliance: Supports compliance with stringent regulatory guidelines (e.g., ICH Q3A/B, USP, EP) for impurity reporting and control.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish the shelf-life of pharmaceutical formulations.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of process-related impurities.

Basic Information

Product Name	Ketorolac Ep Impurity H
CAS No.	80965-09-9
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	Ketorolac Impurity H; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; 1H-Pyrrolizine-1-carboxylic acid, 5-benzoyl-2,3-dihydro-; Ketorolac Related Compound H; Ketorolac EP Impurity H; Ketorolac Tromethamine Impurity H; Ketorolac Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Ketorolac Ep Impurity H is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, NMR), and residual solvent screening, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation.

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 storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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 guidelines
Water Content (KF)	≤ 0.5%

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