Description

Dextropropoxyphene Napsylate Hydrate CAS NO 26570-10-5 is a pharmaceutical-grade active pharmaceutical ingredient (API) and a key chemical intermediate. This compound is valued for its critical role in the synthesis and formulation of specific analgesic medications. It is primarily required by pharmaceutical manufacturers, research institutions, and fine chemical suppliers engaged in the development and production of controlled pharmaceutical products.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in the formulation of specific analgesic medications.
• Reference Standard: Serves as a high-purity standard for quality control and analytical method development in pharmaceutical laboratories.
• Chemical Intermediate: Used in advanced organic synthesis and research-scale production of related chemical entities.
• Pharmacological Research: Employed in preclinical and clinical studies to investigate analgesic mechanisms and efficacy.
• Regulatory Compliance Testing: Essential for batch release testing and stability studies to meet FDA, EMA, and other global regulatory requirements.

Basic Information

Product Name	Dextropropoxyphene Napsylate Hydrate
CAS No.	26570-10-5
Molecular Formula	C28H35NO5 • C10H8O3S • xH2O
Molecular Weight	Contact for details
Synonyms	Dextropropoxyphene Napsylate; Propoxyphene Napsylate; Dextropropoxyphene Napsylate Monohydrate; (±)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol propionate ester 2-naphthalenesulfonate hydrate; Darvon-N; Doloxene; 1,2-Diphenyl-4-dimethylamino-3-methyl-2-propionyloxybutane Napsylate Hydrate; α-d-4-Dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane Napsylate Hydrate
EINECS	Contact for details

Quality Control

Our Dextropropoxyphene Napsylate Hydrate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR spectroscopy, and tests for residual solvents and related substances to ensure compliance with stringent pharmacopeial standards. A Certificate of Analysis (COA) detailing all specifications and results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and potency. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	Contact for details

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