Description

Darunavir Impurity 16 is a designated impurity standard used in the analytical profiling and quality control of the antiretroviral drug Darunavir. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of HIV/AIDS therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Darunavir Impurity 16 in Darunavir API and finished dosage forms.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, particularly HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to monitor and control impurity levels as per ICH guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed as an analytical standard to track the formation of this specific impurity during forced degradation and long-term stability studies of Darunavir.
• Research and Development: Used in R&D laboratories for studying the degradation pathways, synthesis impurities, and metabolic byproducts of Darunavir.

Basic Information

Product Name	Darunavir Impurity 16
CAS No.	1971057-59-6
Molecular Formula	C27H37N3O7S
Molecular Weight	547.67 g/mol
Synonyms	Darunavir Related Compound 16; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate; Darunavir EP Impurity I; Darunavir USP Impurity 16; Prezista Impurity 16; TMC-114 Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Darunavir Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

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

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