Description

Pregabalin-13C3 Solution is a stable isotopically labeled internal standard, essential for precise quantitative analysis in complex matrices. This high-purity reference material is critical for ensuring accuracy and reliability in sensitive analytical methods. It is primarily required by pharmaceutical research, forensic toxicology, and clinical diagnostic laboratories for method development, validation, and quality control.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the accurate LC-MS/MS quantification of pregabalin in biological samples (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion in clinical and preclinical research.
• Forensic and Clinical Toxicology: Used for the definitive identification and measurement of pregabalin in cases of overdose, compliance monitoring, or post-mortem analysis.
• Drug Metabolism Studies: Facilitates the detection and quantification of pregabalin metabolites using mass spectrometry.
• Method Development & Validation: A critical tool for developing, optimizing, and validating new analytical methods to meet regulatory standards (FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Ensures batch-to-batch consistency and purity of pregabalin active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Pregabalin-13C3 Solution
CAS No.	1189980-48-0
Molecular Formula	C8H14N2O2 (13C3)
Molecular Weight	~165.2 g/mol (13C3 labeled)
Synonyms	(S)-3-(Aminomethyl)-5-methylhexanoic acid-13C3; (S)-3-Isobutyl GABA-13C3; CI-1008-13C3; Lyrica-13C3 (labeled analog); (S)-3-(Aminomethyl)-5-methylhexanoic acid (13C3-labeled); Pregabalin (13C3, 98%); Pregabalin-13C3 (methyl-d3) (common search variant); Pregabalin Internal Standard-13C3
EINECS	Contact for details

Quality Control

Every batch of our Pregabalin-13C3 Solution is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure compliance with high-purity standards for analytical reference materials. A comprehensive Certificate of Analysis (COA) detailing isotopic purity, chemical purity, concentration, and solvent verification is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at the recommended temperature (typically 2-8°C or as specified on the label). Keep away from strong acids and organic solvents. For long-term stability, solutions should be stored in appropriate conditions to prevent evaporation or degradation.

Specification

Item	Specification
Appearance	Clear, colorless solution
Concentration	100 µg/mL (or as specified)
Solvent	Methanol, Acetonitrile, or Water (specified per lot)
Chemical Purity (HPLC)	≥98%
Isotopic Purity (MS)	≥98 atom % 13C
Isotopic Enrichment	13C3 (Labeling Position specified)
Identification (IR / MS)	Conforms to reference spectrum
Water Content (KF)	<1.0%

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