Description

Paliperidone Palmitate CAS NO 199739-10-1 is a long-acting ester prodrug of paliperidone, designed for sustained-release pharmaceutical formulations. This compound is critically important for developing extended-release injectable antipsychotic medications, offering improved patient compliance and stable therapeutic plasma levels. It is primarily required by pharmaceutical manufacturers and research institutions focused on innovative neuropsychiatric treatments, including schizophrenia and schizoaffective disorder management.

Application

• Primary Active Pharmaceutical Ingredient (API) in long-acting injectable (LAI) antipsychotic formulations.
• Key intermediate for the synthesis of sustained-release parenteral dosage forms.
• Research and development of novel depot injection systems for chronic mental health conditions.
• Manufacturing of monthly or quarterly administered antipsychotic medications to enhance treatment adherence.
• Preclinical and clinical studies aimed at optimizing pharmacokinetic profiles and reducing dosing frequency.
• Development of combination therapies where sustained paliperidone delivery is a component.
• Analytical reference standard for quality control and regulatory testing of finished drug products.

Basic Information

Product Name	Paliperidone Palmitate
CAS No.	199739-10-1
Molecular Formula	C39H57FN4O4
Molecular Weight	664.89 g/mol
Synonyms	9-Hydroxyrisperidone Palmitate; Paliperidone Palmitate Ester; (9RS)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate; Invega Sustenna (Brand Name Reference); R092670; Paliperidone Palmitate API; Paliperidone Long-Acting Injectable; Paliperidone Palmitate (JAN)
EINECS	Contact for details

Quality Control

Our Paliperidone Palmitate is manufactured under strict quality systems suitable for pharmaceutical development. It undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with ICH guidelines and current industry standards for active pharmaceutical ingredients (APIs). A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing specifications for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	NMT 1.0%
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details

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