Description

Tapentadol o-Sulfate is a specific salt form of the centrally-acting analgesic tapentadol, designed to enhance stability and handling properties. This high-purity pharmaceutical intermediate is critical for ensuring the consistent quality and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by manufacturers in the pharmaceutical industry engaged in the synthesis of tapentadol-based analgesic medications.

Application

• Pharmaceutical Intermediate: Key starting material (KSM) or advanced intermediate in the synthesis of Tapentadol Hydrochloride API.
• Analgesic Drug Manufacturing: Production of finished dosage forms for the management of moderate to severe acute and chronic pain.
• Reference Standard: Serves as a qualitative and quantitative standard in analytical development and quality control laboratories.
• Research & Development: Used in preclinical and clinical studies for the development of novel pain management therapies.
• Process Chemistry: Optimization of scalable and robust synthetic routes for tapentadol production under cGMP conditions.

Basic Information

Product Name	Tapentadol o-Sulfate
CAS No.	1300037-87-9
Molecular Formula	C14H23NO6S
Molecular Weight	333.40 g/mol
Synonyms	Tapentadol Sulfate; 3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol sulfate; Tapentadol o-Sulphate; Tapentadol Hemisulfate; (1R,2R)-3-(3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol sulfate; NU-305 sulfate; CG5503 sulfate
EINECS	Contact for details

Quality Control

Our Tapentadol o-Sulfate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and impurity profiles, suitable for use in pharmaceutical synthesis. Certificates of Analysis (COA) documenting compliance with relevant standards are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
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.