Description

Ketorolac Ep Impurity G is a specified impurity 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 development and validation. It is essential for quality control laboratories and manufacturers in the pharmaceutical industry to ensure the purity, safety, and efficacy of Ketorolac drug substances and products.

Application

• Primary use as a pharmaceutical reference standard for analytical testing.
• Critical component in method development and validation for HPLC, UPLC, and GC analysis.
• Used in quality control (QC) and quality assurance (QA) processes for Ketorolac Tromethamine API.
• Essential for impurity profiling and stability studies of Ketorolac formulations.
• Supports regulatory compliance and submission dossiers (e.g., for FDA, EMA).
• Used in research and development for studying degradation pathways.

Basic Information

Product Name	Ketorolac Ep Impurity G
CAS No.	1391051-90-3
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	Ketorolac Impurity G; Ketorolac Related Compound G; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; (1RS,5RS)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid; Ketorolac EP Impurity G; Ketorolac Tromethamine Impurity G; Ketorolac Degradation Product; Ketorolac Process Impurity
EINECS	Contact for details

Quality Control

Our Ketorolac Ep Impurity G is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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)	≤ 1.0%

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