Description

Rac Ketorolac-D4 CAS NO 1216451-53-4 is a deuterated isotopologue of the non-steroidal anti-inflammatory drug (NSAID) ketorolac, where four hydrogen atoms are replaced with deuterium. This stable isotope-labeled compound is essential for use as an internal standard in quantitative analytical methods, ensuring the highest accuracy and reliability in mass spectrometry-based assays. It is primarily required by pharmaceutical research laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and clinical trial sample analysis.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of ketorolac in complex biological matrices such as plasma, serum, and urine.
• Drug Metabolism Studies (DMPK): Used to track and quantify the parent drug and its metabolites in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Serves as a reference standard to establish selectivity, sensitivity, and reproducibility of analytical methods.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling: Enables accurate measurement of drug concentration-time profiles.
• Clinical Trial Support: Ensures data integrity in bioanalysis for regulatory submissions to agencies like the FDA and EMA.
• Forensic and Toxicology Analysis: Aids in the definitive identification and quantification of ketorolac in forensic investigations.
• Quality Control in Pharmaceutical Manufacturing: Can be used in impurity profiling and stability-indicating assay methods.

Basic Information

Product Name	Rac Ketorolac-D4
CAS No.	1216451-53-4
Molecular Formula	C15H9D4NO3
Molecular Weight	259.29 g/mol (approx.)
Synonyms	(±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid-d4; Ketorolac-d4; Ketorolac (phenyl-d4); rac Ketorolac-d4; Ketorolac (D4); Deuterated Ketorolac; Ketorolac Internal Standard; 2,3-Dihydro-1H-pyrrolizine-1-carboxylic acid, 5-benzoyl-, (±)-, (phenyl-d4)
EINECS	Contact for details

Quality Control

Our Rac Ketorolac-D4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR and Mass Spectrometry for structural confirmation and isotopic purity, and HPLC for chemical purity assessment. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment ensures the material meets the stringent requirements for use in GLP-compliant and regulated bioanalytical laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D4)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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