Description

Ketorolac Related Compound A (20 Mg) (5-Benzoyl-n-(1,3-Dihydroxy-2-(Hydroxymethyl)Propan-2-Yl)-2,3-Dihydro-1H-Pyrrolizine-1-Carboxamide) is a high-purity chemical reference standard, essential for analytical and quality control processes in pharmaceutical development. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the non-steroidal anti-inflammatory drug (NSAID) Ketorolac Tromethamine. It is primarily required by pharmaceutical manufacturers, analytical testing laboratories, and research institutions engaged in method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Ketorolac Tromethamine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, ensuring accurate and reliable analytical results.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and confirm that drug substances and products meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies and Forced Degradation: Acts as a marker compound in studies designed to understand the degradation pathways and shelf-life of Ketorolac formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research and Development: Utilized in synthetic chemistry and pharmacology research to study the structure-activity relationships and metabolism of Ketorolac analogs.

Basic Information

Product Name	Ketorolac Related Compound A (20 Mg) (5-Benzoyl-n-(1,3-Dihydroxy-2-(Hydroxymethyl)Propan-2-Yl)-2,3-Dihydro-1H-Pyrrolizine-1-Carboxamide)
CAS No.	167105-80-8
Molecular Formula	C20H24N2O6
Molecular Weight	388.42 g/mol
Synonyms	Ketorolac Impurity A; Ketorolac Related Substance A; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxamide, N-[1,3-dihydroxy-2-(hydroxymethyl)-2-propanyl]-; Ketorolac Tromethamine Related Compound A; Ketorolac EP Impurity A; Ketorolac USP Related Compound A; (2R,3R)-2,3-Dihydroxy-N-((S)-1-hydroxy-3-((S)-2-oxopyrrolidin-3-yl)propan-2-yl)succinimide (common misassignment check); Ketorolac Degradant
EINECS	Contact for details

Quality Control

Our Ketorolac Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), 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 every shipment, supporting compliance with USP, EP, and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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