Description

Fluphenazine Decanoate Dihydrochloride is a high-purity, long-acting ester prodrug of the typical antipsychotic fluphenazine, formulated as its dihydrochloride salt for enhanced stability and handling. This compound is critical for the development and manufacturing of sustained-release injectable pharmaceutical formulations, primarily used in the management of chronic psychotic disorders. It is an essential active pharmaceutical ingredient (API) and intermediate for pharmaceutical companies, research institutions, and contract development and manufacturing organizations (CDMOs) focused on neuropsychiatric therapeutics.

Application

• Primary Active Pharmaceutical Ingredient (API) for the manufacture of long-acting injectable (LAI) antipsychotic medications.
• Pharmaceutical Intermediate in the synthesis and purification of fluphenazine decanoate formulations.
• Reference Standard for quality control and analytical method development in pharmaceutical laboratories.
• Research & Development of novel drug delivery systems for neuropsychiatric conditions.
• Clinical Trial Material for studies investigating the efficacy and safety of depot antipsychotic therapies.
• Generic Drug Manufacturing for producing bioequivalent versions of established LAI antipsychotics.

Basic Information

Product Name	Fluphenazine Decanoate Dihydrochloride
CAS No.	1006061-35-3
Molecular Formula	C32H44F3N3O2S • 2HCl
Molecular Weight	664.6 g/mol (Free base: 591.8)
Synonyms	Fluphenazine Decanoate Dihydrochloride; Fluphenazine Decanoate HCl; Fluphenazine Decanoate Hydrochloride; 2-[4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]piperazin-1-yl]ethyl decanoate dihydrochloride; Prolixin Decanoate Dihydrochloride; Dapotum D Dihydrochloride; Lyogen-Depot Dihydrochloride; Modecate Dihydrochloride
EINECS	Contact for details

Quality Control

Our Fluphenazine Decanoate Dihydrochloride is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with relevant in-house and industry standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%

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