Description

Sildenafil-D3 is a deuterium-labeled stable isotope analog of Sildenafil, a key active pharmaceutical ingredient. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative analytical methods in pharmaceutical research and quality control. It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical manufacturers engaged in method development, validation, and bioanalytical studies.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical internal standard for the precise quantification of Sildenafil and its metabolites in complex biological matrices such as plasma, serum, and urine.
• Pharmaceutical Method Development & Validation: Used in the development and validation of robust analytical methods to meet stringent regulatory requirements (e.g., FDA, EMA) for drug substance and product testing.
• Bioavailability and Bioequivalence (BA/BE) Studies: Enables accurate pharmacokinetic profiling in clinical trials to assess drug performance and equivalence.
• Metabolite Profiling and Identification: Aids in the identification and quantification of drug metabolites during metabolism and pharmacokinetic studies.
• Quality Control and Assurance (QC/QA): Provides a certified reference material for in-house quality control procedures to ensure batch-to-batch consistency and purity of pharmaceutical products.
• Forensic and Anti-Doping Analysis: Employed in specialized testing laboratories for the detection and confirmation of Sildenafil in forensic investigations and sports doping control.

Basic Information

Product Name	Sildenafil-D3
CAS No.	1126745-90-1
Molecular Formula	C22H27D3N6O4S
Molecular Weight	477.58 g/mol
Synonyms	Deuterated Sildenafil; Sildenafil-d3; 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine-d3; UK-92480-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
EINECS	Contact for details

Quality Control

Our Sildenafil-D3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to confirm identity, purity, and isotopic enrichment. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on assay, chemical purity, and isotopic purity. Our quality commitment ensures the material is suitable for use as a certified reference standard in regulated environments.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions (e.g., nitrogen atmosphere) after opening to maintain stability and prevent degradation. For long-term storage, desiccants are recommended.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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