Description

n-((1-(2-(tert-Butylamino)-2-Oxoethyl)Piperidin-4-Yl)Methyl)-3-Chloro-5-Fluorobenzamide-D9 Hydrochloride Salt is a high-purity, deuterated chemical reference standard essential for advanced analytical and research applications. This compound is critical for ensuring accuracy and reliability in quantitative analysis, particularly in pharmacokinetic and metabolic studies where precise internal standards are required. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in method development and validation for drug discovery and development pipelines.

Application

• Internal Standard for LC-MS/MS: Serves as a critical, isotopically labeled internal standard for the precise quantification of its non-deuterated counterpart in complex biological matrices using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic (PK) Studies: Enables accurate measurement of drug concentration over time in plasma, serum, and tissue samples, supporting ADME (Absorption, Distribution, Metabolism, Excretion) profiling.
• Metabolite Identification & Profiling: Used as a reference material in studies to identify and characterize drug metabolites, aiding in understanding biotransformation pathways.
• Bioanalytical Method Development & Validation: A key component in developing, optimizing, and validating robust, GLP-compliant analytical methods for regulatory submissions.
• Drug Impurity Testing: Acts as a reference standard for identifying and quantifying process-related impurities or degradation products in active pharmaceutical ingredient (API) batches.
• Stable Isotope Labeling Studies: Facilitates research involving tracer techniques to study the fate of molecules in biological systems.

Basic Information

Product Name	n-((1-(2-(tert-Butylamino)-2-Oxoethyl)Piperidin-4-Yl)Methyl)-3-Chloro-5-Fluorobenzamide-D9 Hydrochloride Salt
CAS No.	1346604-21-4
Molecular Formula	C19H19D9ClFN3O2·HCl
Molecular Weight	~ 440.42 g/mol (for monoisotopic mass)
Synonyms	3-Chloro-5-fluoro-N-[[1-[2-[(1,1-dimethylethyl)amino]-2-oxoethyl]-4-piperidinyl]methyl]benzamide-d9 hydrochloride; Benzamide, 3-chloro-5-fluoro-N-[[1-[2-[(1,1-dimethylethyl)amino]-2-oxoethyl]-4-piperidinyl]methyl]-, d9-, hydrochloride; Deuterated Benzamide-D9 Hydrochloride Salt; (1-(2-(tert-Butylamino)-2-oxoethyl)piperidin-4-yl)methyl 3-chloro-5-fluorobenzamide-D9 HCl; n-((1-(2-(tert-Butylamino)-2-oxoethyl)piperidin-4-yl)methyl)-3-chloro-5-fluorobenzamide-d9 hydrochloride
EINECS	Contact for details

Quality Control

Every batch of n-((1-(2-(tert-Butylamino)-2-Oxoethyl)Piperidin-4-Yl)Methyl)-3-Chloro-5-Fluorobenzamide-D9 Hydrochloride Salt is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and isotopic enrichment. Our quality assurance protocols are designed to meet the stringent requirements of research and regulatory environments. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), isotopic purity (by MS), and other critical specifications is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D9)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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