Description

Tapentadol-D5 o-Sulfate is a deuterium-labeled internal standard of the pharmaceutical active ingredient tapentadol, specifically designed for analytical applications. This high-purity reference material is essential for ensuring the accuracy and reliability of quantitative analysis in complex matrices. It is primarily utilized by research institutions, pharmaceutical manufacturers, and contract testing laboratories engaged in method development, pharmacokinetic studies, and quality control.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise quantification of tapentadol and its metabolites in biological samples (e.g., plasma, serum, urine) using LC-MS/MS and HPLC techniques.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and preclinical research.
• Method Development and Validation: Used as a benchmark to develop, optimize, and validate robust analytical methods, ensuring specificity, accuracy, and precision.
• Drug Metabolism Studies: Facilitates the identification and quantification of tapentadol metabolites, aiding in understanding its metabolic pathways.
• Quality Control & Stability Testing: Employed in pharmaceutical quality control laboratories to assay tapentadol content in drug substances and finished dosage forms.
• Forensic and Toxicology Analysis: Supports accurate measurement of tapentadol levels in forensic investigations and toxicological screenings.

Basic Information

Product Name	Tapentadol-D5 o-Sulfate
CAS No.	1346598-84-2
Molecular Formula	C14H18D5NO5S
Molecular Weight	328.41 g/mol (approximate)
Synonyms	Tapentadol-d5 Sulfate; (1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methylpropyl-d5)phenol Sulfate; Tapentadol-D5 Hemisulfate; Tapentadol (phenyl-D5) Sulfate; Tapentadol-D5 Sulfate Salt; Tapentadol-d5 (sulfate); Deuterated Tapentadol Sulfate Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Tapentadol-D5 o-Sulfate is manufactured and analyzed under strict quality management protocols. We provide comprehensive Certificates of Analysis (COA) that detail critical parameters including isotopic purity (deuterium enrichment), chemical purity (by HPLC), and identity confirmation (by NMR and MS). Our quality systems are designed to meet the stringent requirements of analytical reference standard applications, ensuring reliable and reproducible results for our clients' most demanding research.

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 desiccated conditions.

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 Enrichment)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 1.0%
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.