Aripiprazole is a synthetic atypical antipsychotic active pharmaceutical ingredient utilized in oral and injectable psychotherapeutic medications. It acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptors. Produced via controlled chemical synthesis and purification, this small molecule API complies with current pharmacopeial standards for global pharmaceutical development.
Product Specifications
|
Parameter |
Specification Details |
|
International Nonproprietary Name |
Aripiprazole |
|
Chemical Name |
7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one |
|
Appearance |
White to off-white crystalline powder |
|
Solubility |
Practically insoluble in water; slightly soluble in ethanol; soluble in dichloromethane |
|
Storage Conditions |
Preserve in tight containers at controlled room temperature, protected from light and moisture |
Quality & Purity Standards
|
Test Parameter |
Acceptance Criteria |
|
Assay (Anhydrous basis) |
98.0% to 102.0% |
|
Identification |
Conforms to IR and HPLC retention time |
|
Melting Point |
135°C to 140°C |
|
Water Content |
Maximum 0.5% |
|
Residue on Ignition |
Maximum 0.1% |
|
Heavy Metals |
Maximum 10 ppm |
|
Individual Unknown Impurity |
Maximum 0.10% |
|
Total Impurities |
Maximum 0.5% |
|
Residual Solvents |
Compliant with ICH Q3C limits |
|
Particle Size Distribution |
D90 < 50 micrometers (customizable micronization available) |
Manufacturing & Processing Controls
Reaction & Synthesis: Multi-stage batch synthesis utilizing high-purity intermediates within closed-loop reactor systems.
Purification & Crystallization: Controlled temperature crystallization and multi-stage filtration to isolate target compounds.
Drying & Micronization: Vacuum drying followed by jet milling in dedicated containment suites to achieve specified particle size distribution.
Environment: Cleanroom manufacturing adhering to ISO Class 8 standards.
Analytical Testing: In-process controls and final release testing via HPLC, GC, LC-MS, and ICP-MS.
Capacity: Commercial scale production spanning multi-hundred-kilogram to metric-ton annual volumes.
Regulatory Documentation
Drug Master File (DMF)
Available in open and closed part format for regulatory submission support.
Certificate of Analysis (CoA)
Issued per commercial batch detailing assay, impurity profiling, and residual solvent values.
Certificate of Suitability (CEP)
Regulatory packages aligned with EDQM guidelines available upon request.
Regulatory Declarations
Comprehensive statements covering TSE/BSE safety, genotoxic impurity risk evaluations, and REACH compliance.
Stability Data
Long-term (25°C / 60% relative humidity) and accelerated (40°C / 75% relative humidity) stability summaries.
Packaging & Handling
|
Primary Packaging |
Double-layer medical-grade low-density polyethylene bags, heat-sealed under positive pressure. |
|
Secondary Packaging |
Rigid fiber drums providing complete moisture and light barrier protection. |
|
Standard Net Weight |
25 kg per drum (customizable configurations available). |
|
Labeling |
Lot-specific labeling displaying product name, CAS number, batch number, net weight, manufacturing date, retest date, and storage requirements. |
Pharmaceutical Applications
Oral Solid Dosage Formulation: Active ingredient in immediate-release tablets, orally disintegrating tablets, and oral solutions for treating schizophrenia and acute manic episodes. Enables precise dosing within solid dispersion matrix formulations and supports stable tablet compression.
Adjunctive Therapy Formulations: Incorporated into medications intended for adjunctive treatment of major depressive disorder. Maintains chemical stability across standard excipient blending processes and ensures consistent dissolution rates.
Extended-Release Injectable Suspensions: Processed into specialized sterile particle size distributions for long-acting injectable depot formulations. Facilitates controlled crystal growth suppression and meets stringent particulate matter limits.
FAQ
Q: What is the primary regulatory status of this API?
A: Manufactured in compliance with current Good Manufacturing Practices, supported by a comprehensive Drug Master File ready for regulatory review.
Q: Can the particle size distribution be customized?
A: Yes, micronization parameters can be adjusted via jet milling to meet specific target requirements for direct compression or suspension manufacturing.
Q: What analytical methods are utilized for quality control?
A: Assay and related substances are quantified using validated high-performance liquid chromatography methods aligned with current pharmacopeial guidelines.
Q: What is the standard retest period and storage condition?
A: The standard retest period is 24 months from the manufacturing date when stored in airtight containers at controlled room temperature, protected from direct light and moisture.
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