Description

[13C8]-Nifedipine CAS NO 1173023-46-5 is a stable isotope-labeled analog of the widely used calcium channel blocker nifedipine, where eight carbon atoms are replaced with the carbon-13 (13C) isotope. This compound is an essential internal standard for the precise and accurate quantification of nifedipine in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development and validation.

Application

• Bioanalytical Internal Standard: Serves as a critical reference compound for the quantitative analysis of nifedipine in plasma, serum, and other biological fluids via mass spectrometry.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development & Validation: Used as a spiking standard to establish and validate robust, GLP-compliant LC-MS/MS methods for nifedipine assay.
• Doping Control & Forensic Analysis: Supports the detection and confirmation of nifedipine in sports anti-doping programs and forensic toxicology investigations.
• Stable Isotope Dilution Assay (SIDA): Fundamental component in SIDA protocols to achieve high precision by correcting for analyte loss during sample preparation and instrument variability.
• Pharmaceutical Quality Control: Can be utilized in advanced QC laboratories for specific impurity profiling or trace-level analysis of drug substances and products.

Basic Information

Product Name	[13C8]-Nifedipine
CAS No.	1173023-46-5
Molecular Formula	13C8H14N2O6
Molecular Weight	~358.3 g/mol (for 13C8 isotopologue)
Synonyms	Nifedipine-13C8; 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-13C8-3,5-pyridinedicarboxylic acid dimethyl ester; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester-13C8; Nifedipine (phenyl-13C6, carbonyl-13C2); Labeled Nifedipine; Stable Isotope-Labeled Nifedipine; 13C-Labeled Nifedipine Internal Standard
EINECS	Contact for details

Quality Control

Every batch of [13C8]-Nifedipine is manufactured and analyzed under strict quality protocols to ensure the high chemical purity and isotopic enrichment required for sensitive mass spectrometry applications. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request and provide detailed data on purity (HPLC), isotopic purity (MS), and chemical identity.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C
Isotopic Enrichment	≥ 98% on each labeled position (by MS)
Chemical Purity	≥ 95% (by NMR)
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.