Description

n-Desmethyl Sildenafil-D8 is a high-purity, deuterium-labeled internal standard critical for accurate analytical quantification. This compound is essential for ensuring precision and reliability in sensitive mass spectrometry-based assays, particularly for pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic analysis facilities requiring definitive reference materials for sildenafil and its metabolite analysis.

Application

• Quantitative Internal Standard for LC-MS/MS: Used as a deuterated internal standard for the precise quantification of sildenafil and its metabolites in biological matrices (plasma, serum, urine).
• Pharmaceutical Research & Development: Supports method development and validation for bioanalytical studies related to erectile dysfunction and pulmonary arterial hypertension treatments.
• Forensic Toxicology: Enables accurate detection and measurement of sildenafil and its analogs in forensic casework and doping control analysis.
• Metabolite Profiling: Aids in the identification and study of metabolic pathways and pharmacokinetics of sildenafil in clinical trials.
• Quality Control in API Manufacturing: Serves as a reference standard for the quality control of active pharmaceutical ingredient (API) batches.
• Regulatory Compliance Testing: Facilitates testing to meet stringent regulatory requirements from agencies like the FDA and EMA for drug approval and post-market surveillance.

Basic Information

Item	Detail
Product Name	n-Desmethyl Sildenafil-D8
CAS No.	1185168-06-2
Molecular Formula	C21H22D8N6O4S
Molecular Weight	482.60 g/mol
Synonyms	UK-103,320-D8; Desmethyl Sildenafil-d8; 5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl-d8)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one; UK 103320-d8; N-Desmethyl Sildenafil D8; Sildenafil Impurity D8; Sildenafil Metabolite D8; Deuterated UK-103,320
EINECS	Contact for details

Quality Control

Every batch of n-Desmethyl Sildenafil-D8 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a certified reference material. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting critical parameters including chemical purity, isotopic purity (D-enrichment), and chromatographic profile. Our quality commitment ensures consistency and reliability for your most demanding analytical applications.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccant use.

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 (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets 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.