Description

Dolutegravir-D5 is a deuterated isotopologue of the integrase strand transfer inhibitor Dolutegravir, specifically labeled with five deuterium atoms. This stable isotope-labeled compound is a critical reference standard and intermediate for the development and validation of highly sensitive bioanalytical methods, such as LC-MS/MS, in pharmacokinetic and metabolism studies. It is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the production and quality control of antiviral therapeutics.

Application

• Internal Standard for Bioanalysis: Serves as a crucial internal standard in quantitative LC-MS/MS assays for the accurate measurement of Dolutegravir concentrations in biological matrices (plasma, serum, tissues).
• Metabolite Tracing & Pharmacokinetic Studies: Used as a tracer in drug metabolism and disposition (DMPK) studies to elucidate metabolic pathways and pharmacokinetic profiles without isotopic interference.
• Method Development & Validation: A key component in developing, validating, and ensuring regulatory compliance (FDA, EMA) of analytical methods for generic and innovator drug products.
• Pharmaceutical Impurity Profiling: Employed as a reference marker in stability studies and impurity characterization for drug substance and finished product quality control.
• Synthetic Intermediate: Acts as a labeled building block for the synthesis of more complex deuterated drug molecules or metabolites for advanced research applications.

Basic Information

Product Name	Dolutegravir-D5
CAS No.	2249814-82-0
Molecular Formula	C20H14D5F2N3O5
Molecular Weight	420.40 g/mol (approximate)
Synonyms	(4R,12aS)-4-(Deuteriomethyl)-3,4,12,12a-tetrahydro-7,8-difluoro-6-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide-d4; Dolutegravir (methyl-d3, 12a-d2); S/GSK1349572-D5; GSK1349572-D5; Tivicay-D5 (labeled form); Deuterated Dolutegravir; Dolutegravir-d5
EINECS	Contact for details

Quality Control

Our Dolutegravir-D5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR and Mass Spectrometry for isotopic enrichment confirmation, and HPLC for chemical and isotopic purity assessment. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, isotopic abundance, and residual solvents, ensuring traceability and compliance with research-grade standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Keep the container tightly sealed in a desiccated environment after opening.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0% (chemical purity)
Isotopic Purity (HPLC-MS)	≥ 98.0 atom % D
Isotopic Enrichment	≥ 95% D5 (by MS)
Water Content (KF)	≤ 1.0%
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.