Description

Ketorolac Impurity 48 is a high-purity chemical reference standard used in the analytical profiling of the non-steroidal anti-inflammatory drug (NSAID) Ketorolac Tromethamine. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a key marker for identifying and quantifying process-related impurities. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and batch release testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ketorolac-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels against ICH Q3A/B guidelines, ensuring batch-to-batch consistency.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH stability guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to identify and control specific synthetic impurities.

Basic Information

Product Name	Ketorolac Impurity 48
CAS No.	857230-90-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketorolac Related Compound 48; Ketorolac Tromethamine Impurity 48; 5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic Acid Impurity; (RS)-5-Benzoyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic Acid Impurity; Ketorolac Process Impurity; Ketorolac Degradant; Toradol Impurity 48
EINECS	Contact for details

Quality Control

Our Ketorolac Impurity 48 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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