Description

Raltegravir-13C6 Potassium Salt is a stable isotope-labeled internal standard of the HIV integrase inhibitor Raltegravir, where six carbon atoms are replaced with the 13C isotope. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as Liquid Chromatography-Mass Spectrometry (LC-MS/MS), in pharmacokinetic and drug metabolism studies. It is a critical tool for pharmaceutical research and development laboratories, clinical testing facilities, and regulatory bodies requiring precise measurement of Raltegravir in biological matrices.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the precise quantification of Raltegravir in plasma, serum, and other biological samples using LC-MS/MS.
• Pharmacokinetic (PK) Studies: Enables accurate determination of drug concentration-time profiles, bioavailability, and half-life during clinical trials.
• Drug Metabolism and Disposition (DMPK): Used in studies investigating the absorption, distribution, metabolism, and excretion (ADME) of Raltegravir.
• Therapeutic Drug Monitoring (TDM): Supports assays designed to monitor Raltegravir levels in patients to optimize dosing and efficacy.
• Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Reference Material: Acts as a certified reference material for quality control and assurance in analytical laboratories.

Basic Information

Item	Detail
Product Name	Raltegravir-13C6 Potassium Salt
CAS No.	1391053-33-0
Molecular Formula	C20H1813C6F3KN5O5
Molecular Weight	~ 527.48 (for 13C6 labeled form)
Synonyms	Raltegravir-13C6 K Salt; N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide-13C6 Potassium Salt; Isentress-13C6 Internal Standard; MK-0518-13C6 Potassium Salt; (4R,12aS)-N-[(4-Fluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide-13C6 Potassium Salt
EINECS	Contact for details

Quality Control

Our Raltegravir-13C6 Potassium Salt is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical identity, which are critical for its use as an internal standard. Each batch is analyzed using advanced techniques including NMR, HPLC, and High-Resolution Mass Spectrometry (HRMS) to confirm isotopic enrichment (>99% 13C6) and chemical purity. A comprehensive Certificate of Analysis (COA) detailing assay, isotopic purity, and impurity profile is provided with every shipment.

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 must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (Mass Spec)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C6)	≥ 99 atom % 13C
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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