Description

Desethyl Sildenafil-D3 is a deuterium-labeled analog of a key sildenafil metabolite, designed for use as an internal standard in analytical chemistry. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative analyses in regulated environments. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control facilities specializing in bioanalytical method development and pharmacokinetic studies.

Application

• Internal Standard for LC-MS/MS: Essential for the precise quantification of sildenafil and its metabolites in biological matrices (e.g., plasma, serum) during pharmacokinetic and bioequivalence studies.
• Pharmaceutical Research & Development: Used in method development and validation for drug metabolism and pharmacokinetics (DMPK) studies of PDE5 inhibitors.
• Forensic and Anti-Doping Analysis: Serves as a critical reference compound in the detection and confirmation of sildenafil and related substances in forensic toxicology and sports doping control.
• Quality Control & Reference Standard: Employed as a certified reference material (CRM) to calibrate equipment and verify analytical methods in pharmaceutical quality assurance laboratories.
• Metabolite Identification Studies: Aids in the structural elucidation and tracking of sildenafil's metabolic pathways in in vitro and in vivo studies.

Basic Information

Product Name	Desethyl Sildenafil-D3
CAS No.	1346603-75-5
Molecular Formula	C₂₁H₂₆D₃N₆O₄S
Molecular Weight	~ 478.59 g/mol
Synonyms	UK-103,320-D3; N-Desethyl Sildenafil-D3; 5-[2-Ethoxy-5-[(4-methyl-1-piperazinyl-d3)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one; Deuterated Desethyl Sildenafil; Sildenafil Metabolite M1-D3; UK 103320 D3; PDE5 Inhibitor Metabolite-D3
EINECS	Contact for details

Quality Control

Every batch of Desethyl Sildenafil-D3 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a high-grade reference standard. Certificates of Analysis (COA) are supplied with each shipment, detailing results for identity, purity (by HPLC), chemical purity, isotopic purity (D-content), and residual solvents. Our quality commitment ensures compliance with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Chemical Purity	≥ 95.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
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.