Description

Saquinavir-D9 CAS NO 1356355-11-7 is a deuterated internal standard of the antiretroviral drug Saquinavir, where nine hydrogen atoms are replaced with stable deuterium isotopes. This compound is critically important for ensuring the accuracy and reliability of quantitative bioanalytical methods, such as Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Pharmaceutical research and development laboratories, clinical testing facilities, and contract research organizations (CROs) require this high-purity standard for precise pharmacokinetic studies, drug metabolism research, and therapeutic drug monitoring.

Application

• Quantitative Bioanalysis: Serves as an essential internal standard for the accurate LC-MS/MS quantification of Saquinavir in biological matrices (plasma, serum, tissue).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise measurement of drug concentration-time profiles to determine absorption, distribution, metabolism, and excretion.
• Drug Metabolism and Disposition Research: Used in metabolite identification and stability studies to understand the biotransformation pathways of Saquinavir.
• Clinical Trial Support: Critical for ensuring data integrity in bioanalytical assays supporting clinical trials for HIV protease inhibitors.
• Therapeutic Drug Monitoring (TDM): Facilitates the development and validation of robust assays for monitoring Saquinavir levels in patient samples to optimize dosing regimens.
• Method Development and Validation: A key reagent for developing, optimizing, and validating new analytical methods in compliance with FDA and ICH guidelines.
• Quality Control in Reference Material Production: Used as a calibrant or system suitability standard in the production and certification of Saquinavir reference standards.

Basic Information

Product Name	Saquinavir-D9
CAS No.	1356355-11-7
Molecular Formula	C38H41D9N6O5
Molecular Weight	~ 679.88 g/mol
Synonyms	Deuterated Saquinavir (D9); Saquinavir-d9; [2S-[2R*,3S*]]-N-[2S-[[(1,1-Dimethylethyl)amino]carbonyl]-4-[(3-pyridinylmethyl)amino]phenyl]-2-[(2-quinolinylcarbonyl)amino]-1,2,3,4-tetrahydro-3-isoquinolinecarboxamide-d9; Ro 31-8959-d9; Invirase-d9; Fortovase-d9; HIV-1 Protease Inhibitor-d9
EINECS	Contact for details

Quality Control

Our Saquinavir-D9 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing specifications for chemical purity, isotopic purity (D-enrichment), and chromatographic profile. We adhere to relevant industry guidelines for reference standards and can support method validation packages.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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