Amisulpride Pharmaceutical API
Pharmaceutical Premium
Pharmaceutical API

Amisulpride

High-purity pharmaceutical grade Amisulpride API manufactured to meet stringent USP/EP specifications for antipsychotic medication production. Our pharmaceutical-grade Amisulpride delivers exceptional quality and consistency for critical pharmaceutical applications.

  • USP/EP Compliant Grade
  • High Purity (>99.5%)
  • Benzisoxazole Antipsychotic
  • GMP Certified Manufacturing
  • Reliable Supply Chain
  • Complete Documentation
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Technical Specifications

Chemical Formula: C17H27N3O4S
CAS Number: 71675-85-9
Molecular Weight: 369.48 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 5kg, 10kg pharmaceutical containers

Applications

Antipsychotic Drug Manufacturing
Neurological Formulations
Oral Pharmaceutical Products
API Synthesis & Development
Psychiatric Research
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Amisulpride grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Oral dosage forms

Quality Standards

DRAVYOM's pharmaceutical grade Amisulpride is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Amisulpride exhibits exceptional chemical properties essential for psychiatric therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Sparingly soluble
LogP (octanol/water): 2.8
pKa: 9.0 ± 0.1
UV λmax: 277 nm (methanol)
Physical Properties
Melting Point: 129-133°C
Bulk Density: 0.5-0.7 g/mL
Crystalline Form: White crystalline powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 48%
Protein Binding: 16%
Half-life: 12 hours
Elimination: Primarily renal (unchanged)
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 15-25°C
pH Stability Range: 4.0-8.0

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Amisulpride superiority in psychiatric applications with exceptional D2/D3 receptor selectivity, precision, and reproducibility across diverse schizophrenia treatment protocols and research procedures.

Pharmaceutical Performance

Assay: ≥99.0% active pharmaceutical ingredient

Exceptional purity for psychiatric formulations
Receptor Selectivity

Binding: High D2/D3 receptor affinity

Superior antipsychotic selectivity
Dissolution Rate

Solubility: Consistent bioavailability

Reliable absorption characteristics
Thermal Stability

Working range: 15-25°C optimal storage

Maintains potency across temperature range
Batch Consistency

Variation: ±0.2% between manufacturing batches

Exceptional lot-to-lot reproducibility
Extended Stability

3 years shelf life under recommended conditions

Long-term pharmaceutical grade integrity

Safety Information

Psychiatric pharmaceutical compound requiring specialized handling procedures. Use appropriate personal protective equipment and follow institutional drug handling protocols. Avoid skin contact and inhalation. Handle in well-ventilated areas and ensure proper safety measures for psychoactive compounds.

Health Hazard
Psychoactive
Avoid Contact

Storage & Handling

Store in original containers in a cool, dry area (15-25°C) away from light and incompatible materials. Keep containers tightly closed and protect from moisture. Use specialized pharmaceutical storage protocols for controlled substances and ensure proper material identification and segregation.

Controlled temperature (15-25°C)
Protect from light
Secure storage area
Protect from moisture

Chemical Mechanisms & Reaction Pathways

Amisulpride exhibits selective dopamine receptor antagonism, enabling precise psychiatric applications with predictable pharmacokinetic pathways and quantitative neurotransmitter modulation mechanisms.

D2/D3 Receptor Selectivity

Selective antagonism of dopamine D2 and D3 receptors

Quantitative antipsychotic activity
Limbic Selectivity

Preferential binding in limbic versus striatal regions

Essential for reduced extrapyramidal effects
Dose-Dependent Effects

Low-dose dopamine autoreceptor blockade, high-dose postsynaptic blockade

Enables flexible therapeutic dosing
Minimal Metabolism

Primarily renal elimination without significant metabolism

Predictable pharmacokinetic profile

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and pharmaceutical manufacturing validations.

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonization pharmaceutical compliance

FDA Registration

United States Food and Drug Administration compliance

Method Validation

Supported analytical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Amisulpride performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence validation
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical grade Amisulpride production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical grade Amisulpride quality and performance across all production batches.

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical containers with controlled atmosphere packaging

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Amisulpride effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: Consistent therapeutic levels Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 400+ published research applications Reproducibility: >98% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 25% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional therapeutic performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and regulatory compliance support

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services