Paliperidone Palmitate

Paliperidone Palmitate is a long-acting atypical antipsychotic agent and the palmitate ester prodrug of Paliperidone (9-hydroxyrisperidone), the primary active metabolite of risperidone. Paliperidone Palmitate functions as a potent dopamine D₂ receptor antagonist and serotonin 5-HT₂ receptor antagonist, with high affinity for cloned human 5-HT₂A receptors (Ki = 0.4 nM). Paliperidone Palmitate is marketed under the brand names Invega Sustenna® (1-month formulation) and Invega Trinza® (3-month formulation) for the treatment of schizophrenia. Paliperidone Palmitate is also recognized as a critical reference standard for impurity profiling and quality control in the manufacturing of paliperidone-containing pharmaceutical products. In quality control contexts, Paliperidone Palmitate serves as both the active pharmaceutical ingredient (API) standard and as a reference material for ANDA filings, where it is used in analytical method development, method validation (AMV), and quality control (QC) applications.

Product Parameters

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Parameter	Specification
Product Name	Paliperidone Palmitate
CAS Number	199739-10-1
Molecular Formula	C₃₉H₅₇FN₄O₄
Molecular Weight	664.89 g/mol
Melting Point	110–115°C
Boiling Point	736.3 ± 70.0 °C (Predicted)
Density	1.19
pKa	8.07 ± 0.10 (Predicted)
Solubility	Chloroform (Slightly) Ethyl Acetate (Slightly, Heated, Sonicated) Methanol (Slightly) practically insoluble in water
Physical Form	Solid
Appearance	Off-White to Light Beige powder
Storage Condition	Sealed in dry, store in freezer under –20°C

 

Why Cosperpharm?

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When your paliperidone manufacturing campaign or ANDA filing demands a reliable source of Paliperidone Palmitate — whether as the API itself or as a reference standard — Cosperpharm delivers with the analytical rigor, documentation depth, and supply flexibility that pharmaceutical customers require.

 

The prodrug starts here. Paliperidone Palmitate is the cornerstone of long-acting injectable antipsychotic therapy. Any impurity in this ester prodrug — whether process-related or degradant — will carry through to the final drug product and compromise patient safety and product quality. Our analytical release protocol for Paliperidone Palmitate includes HPLC purity verification (≥98.0%), identity confirmation, residual solvent analysis, and water content determination — because the performance of your extended-release suspension depends on the purity of this ester.

 

Documentation that supports regulatory submission. As both the API and a critical reference standard for ANDA filings, Paliperidone Palmitate shipments include a Certificate of Analysis (COA) with batch-specific HPLC purity, chromatographic traceability, and full characterization data — structured for direct insertion into your method validation package. DMF-ready documentation, stability summaries, and custom quality agreements are available upon request.

 

Flexible supply across all development stages. Cosperpharm supplies Paliperidone Palmitate across the full range of applications — from reference standard quantities for QC impurity profiling and analytical method development, to kilogram-scale batches for commercial manufacturing. R&D samples ship within 5–7 business days; bulk orders ship within 2–3 weeks.

 

Technical support for the full synthetic cascade. Our process chemistry team can advise on the esterification conditions for Paliperidone Palmitate synthesis, impurity profiling strategies, and analytical methods for detecting process-related impurities — because we have extensive experience with this compound across multiple manufacturing campaigns.

 

Global reach with transparent pricing. Cosperpharm ships to pharmaceutical manufacturers, CROs, and analytical laboratories worldwide, with full customs documentation included. Volume discounts apply at larger scales, and we communicate lead times upfront — no hidden fees, no unexpected delays.

FAQ

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Q1: What is the difference between Paliperidone Palmitate and Paliperidone?

A: Paliperidone Palmitate (CAS 199739-10-1) is the palmitate ester prodrug of Paliperidone (CAS 144598-75-4). Paliperidone is the active antipsychotic moiety (9-hydroxyrisperidone), while Paliperidone Palmitate is the long-acting injectable prodrug that slowly hydrolyzes to release Paliperidone over extended periods.

 

 Q2: What are the primary pharmaceutical applications?

A: Paliperidone Palmitate is indicated for the treatment of schizophrenia and schizoaffective disorder. It is administered as a long-acting intramuscular injection, providing sustained therapeutic plasma concentrations over 1, 3, or 6 months depending on the formulation.

 

Storage Conditions

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Store Paliperidone Palmitate in a tightly sealed container under inert atmosphere (nitrogen or argon) at –20°C for long-term storage. Short-term storage at 2–8°C is acceptable. Keep the container dry, protected from light, and stored in a clean, well-ventilated area away from strong oxidizing agents and sources of ignition. The compound is air-sensitive and heat-sensitive; therefore, storage under inert gas is strongly recommended.

 

Shelf life: 3 years when stored at –20°C in a sealed container under inert atmosphere. Stock solutions, once prepared, should be stored aliquoted in tightly sealed vials and used within 1 month. Avoid repeated freeze-thaw cycles.

 

Handling precautions: Use only in a fume hood. Wear chemical-resistant gloves, safety goggles, and a lab coat. Avoid generating dust or aerosols. Do not eat, drink or smoke in work areas. After handling, wash hands thoroughly. Contaminated clothing should be removed and washed before reuse. Refer to the Safety Data Sheet (SDS) for complete safety information.

 

Contact Us

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Ready to secure high‑purity Paliperidone Palmitate for your long‑acting injectable formulation or ANDA reference standard program? Cosperpharm is your partner from early‑stage R&D through commercial production. Our team provides rapid quotations, transparent lead times, and full regulatory documentation packages – including COAs, stability summaries, and DMF‑ready files. Whether you need 1 gram for impurity profiling or 25 kilograms for manufacturing, we deliver with consistency and traceability.

 

Reach out to our pharmaceutical sales team via the contact form on our website or email us directly. We typically respond within 24 hours and can arrange custom packaging, expedited shipping, or a quality audit upon request. Let’s move your Paliperidone Palmitate project forward – contact Cosperpharm today.