Description

Oseltamivir-13Cd3 CAS NO 1093851-61-6 is a stable isotope-labeled analog of the antiviral drug oseltamivir, specifically deuterated at three positions with carbon-13. This compound is an essential reference standard and internal standard for the precise quantification and pharmacokinetic profiling of oseltamivir in complex biological matrices. It is primarily required by pharmaceutical research laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development, bioequivalence studies, and clinical research.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in LC-MS/MS and GC-MS methods for the accurate measurement of oseltamivir and its active metabolite in plasma, serum, and other biological fluids.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables reliable tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical trials.
• Metabolite Profiling and Identification: Used in mass spectrometry to differentiate drug-derived metabolites from endogenous compounds, aiding in metabolic pathway elucidation.
• Method Development and Validation: Essential for developing robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control in Manufacturing: Can be utilized as a reference standard to assess the purity and potency of oseltamivir active pharmaceutical ingredient (API) and finished dosage forms.
• Doping Control and Forensic Analysis: Supports the detection and confirmation of oseltamivir in sports anti-doping programs and forensic investigations.

Basic Information

Product Name	Oseltamivir-13Cd3
CAS No.	1093851-61-6
Molecular Formula	C16H2513Cd3N2O4
Molecular Weight	Contact for details
Synonyms	Tamiflu-13Cd3; (3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester-13Cd3; GS 4104-13Cd3; Oseltamivir-d3 (13C labeled); Ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate-13Cd3; Deuterated Oseltamivir (13C3); Oseltamivir Internal Standard-13Cd3
EINECS	Contact for details

Quality Control

Our Oseltamivir-13Cd3 is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic purity, and residual solvents. We support compliance with cGMP and relevant ICH guidelines for reference standards.

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 should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.