Description

Fluphenazine Decanoate is a long-acting esterified derivative of the typical antipsychotic fluphenazine, designed for depot injection. This formulation is critical for ensuring sustained therapeutic plasma levels, thereby improving patient compliance in long-term treatment regimens. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers producing long-acting injectable antipsychotic medications for conditions such as schizophrenia and other psychotic disorders.

Application

• Primary Active Pharmaceutical Ingredient (API) for the formulation of long-acting injectable (depot) antipsychotic medications.
• Used in the manufacturing of generic and branded pharmaceutical products for the management of chronic psychotic disorders, including schizophrenia.
• Essential in clinical settings requiring controlled and sustained drug release over weeks to months from a single intramuscular or subcutaneous injection.
• Applied in hospital and institutional pharmacy compounding for specialized dosage forms, under strict regulatory oversight.
• Supplied to contract development and manufacturing organizations (CDMOs) for drug product development and scale-up.
• Utilized in research and development for novel delivery systems and comparative bioavailability studies.

Basic Information

Product Name	Fluphenazine Decanoate
CAS No.	5002-47-1
Molecular Formula	C32H44F3N3O2S
Molecular Weight	591.78 g/mol
Synonyms	Fluphenazine Decanoate; Flufenazina Decanoato; Fluphenazini Decanoas; 4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazineethanol decanoate ester; Prolixin Decanoate; Dapotum D; Modecate; Anatensol Decanoate; Fluphenazine Heptanoate (related ester); SQ 10733; NSC-77370
EINECS	225-668-9

Quality Control

Our Fluphenazine Decanoate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs where applicable. Every batch undergoes comprehensive analytical testing for identity, potency, purity, and related substances. A Certificate of Analysis (COA) detailing results for assay, impurities, residual solvents, and other critical parameters is provided to ensure full traceability and compliance with cGMP guidelines for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 0.5%
Related Substances (HPLC)	Total impurities: NMT 2.0% Any individual impurity: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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