Description

Udenafil-D7 CAS NO 1175992-76-3 is a deuterated isotopologue of the active pharmaceutical ingredient udenafil, specifically labeled with seven deuterium atoms. This high-purity reference standard is critical for ensuring analytical accuracy and reliability in pharmaceutical research and development. It is primarily utilized by analytical chemists and quality control laboratories in the pharmaceutical and biotechnology sectors for applications such as quantitative analysis, metabolism studies, and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the precise quantification of udenafil and its metabolites in complex biological matrices using LC-MS/MS and GC-MS.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used as a stable isotope-labeled tracer to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of udenafil.
• Bioanalytical Method Development and Validation: Essential for developing and validating robust, sensitive, and specific analytical methods in compliance with ICH and FDA guidelines.
• Impurity Profiling and Characterization: Aids in the identification and quantification of process-related impurities and degradation products during drug substance and drug product development.
• Clinical Trial Support: Provides reliable data for pharmacokinetic and bioequivalence studies during clinical phases of drug development.
• Quality Control and Assurance: Ensures batch-to-batch consistency and verifies the identity and purity of non-deuterated udenafil in active pharmaceutical ingredient (API) manufacturing.

Basic Information

Product Name	Udenafil-D7
CAS No.	1175992-76-3
Molecular Formula	C₂₅H₂₅D₇N₆O₃S
Molecular Weight	503.66 g/mol
Synonyms	Udenafil-d7; 5-[2-Propyloxy-5-(1-methyl-2-pyrrolidinylethylamidosulfonyl)phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one-d7; Zydena-d7; DA-8159-d7; (R)-5-(2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl)-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one-d7; Deuterated Udenafil
EINECS	Contact for details

Quality Control

Every batch of Udenafil-D7 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that detail critical parameters including isotopic purity, chemical purity, and identity confirmation. Our quality protocols are designed to meet the stringent requirements for pharmaceutical reference standards, supporting compliance with cGMP and relevant ICH guidelines for analytical procedures.

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 handled in a dry environment to maintain stability and purity. 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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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