Description

Solifenacin-D5 Hydrochloride is a deuterated isotopologue of the active pharmaceutical ingredient solifenacin, specifically labeled with five deuterium atoms. This stable-labeled compound is an essential internal standard for the precise and accurate quantification of solifenacin in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is a critical tool for researchers and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors, ensuring reliable data for pharmacokinetic studies, bioequivalence testing, and method validation.

Application

• Internal Standard for Bioanalysis: Primary use as a stable isotope-labeled internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the quantification of solifenacin in plasma, serum, and urine.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Method Development and Validation: Serves as a critical reference compound for developing, optimizing, and validating robust analytical methods in compliance with GLP and GCP guidelines.
• Drug Impurity Profiling: Used in comparative analyses to identify and characterize potential deuterated impurities or metabolites in drug substances and products.
• Forensic and Doping Control Analysis: Supports highly specific and confirmatory testing in forensic toxicology and anti-doping laboratories.

Basic Information

Product Name	Solifenacin-D5 Hydrochloride
CAS No.	1426174-05-1
Molecular Formula	C23H21D5ClN2O2 • HCl
Molecular Weight	434.42 g/mol (for monoisotopic)
Synonyms	(3R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate-d5 hydrochloride; (1S,3'R)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-3'-carboxylic acid quinuclidin-3'-yl ester-d5 hydrochloride; Vesicare-d5 hydrochloride; YM905-d5 hydrochloride; deuterated Solifenacin HCl; Solifenacin-(phenyl-d5) Hydrochloride
EINECS	Contact for details

Quality Control

Our Solifenacin-D5 Hydrochloride is manufactured under controlled conditions to ensure the highest standards of isotopic purity and chemical integrity. Each batch undergoes rigorous analytical testing, including HPLC for chemical purity, NMR and MS for structural and isotopic confirmation, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, isotopic enrichment, and impurities is provided to support your regulatory and research requirements.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 2.0%
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.