Description

Dolutegravir Impurity 16 CAS NO 1357289-37-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Dolutegravir, an integrase strand transfer inhibitor. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Dolutegravir API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for accurate impurity identification and quantification.
• Stability Studies & Degradation Profiling: Employed to monitor and characterize potential degradation products in Dolutegravir formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity identification and control strategies (ICH Q3A/B).
• Research & Development: Serves as a key intermediate or marker in synthetic pathway research and for studying the metabolism and pharmacokinetics of Dolutegravir.
• Calibration & System Suitability: Used to calibrate analytical instruments and perform system suitability tests to ensure the accuracy and precision of impurity analysis.

Basic Information

Product Name	Dolutegravir Impurity 16
CAS No.	1357289-37-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dolutegravir Related Compound 16; Dolutegravir EP Impurity J; Dolutegravir Process Impurity; (4R,12aS)-N-(2,4-Difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide; S/GSK1349572 Impurity 16; Tivicay Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Dolutegravir Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to your specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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