Synthesis Department
Custom Synthesis Services at Topiox Research, Navi Mumbai, India
At Topiox Research, we specialize in custom synthesis services for the pharmaceutical and chemical industries, delivering high-purity compounds, reference standards, and specialty intermediates to support research, process development, and regulatory submissions.
Located in Navi Mumbai, India, our Synthesis Department offers a full spectrum of chemical synthesis services, from impurity synthesis and Excipient development to custom polymer synthesis and process optimization.
As one of India’s leading custom chemical synthesis companies, we combine scientific precision, regulatory compliance, and analytical validation to deliver tailored chemistry solutions aligned with regulatory guidelines.
Located in Navi Mumbai, India, our Synthesis Department offers a full spectrum of chemical synthesis services, from impurity synthesis and API development to custom polymer synthesis and process optimization.
As one of India’s leading custom chemical synthesis companies, we combine scientific precision, regulatory compliance, and analytical validation to deliver tailored chemistry solutions aligned with FDA, ICH, and ISO 9001:2015 guidelines.
Our Core Synthesis Capabilities
Custom Synthesis Services
We provide custom chemical synthesis for Excipients, intermediates, and impurities, including Nitrosamine impurities and degradation products.
Our expert chemists design scalable synthesis pathways focused on purity, reproducibility, and regulatory readiness.
Our capabilities include:
- Multi-step organic synthesis for complex molecules
- Custom polymer synthesis for formulation and research applications
- Synthesis of reference standards and process intermediates
- GLP-compliant small-to-large scale synthesis under strict quality controls
Impurity Synthesis and Characterization
Impurities are critical to understanding drug safety and quality.
We specialize in the synthesis of impurities for reference standards, impurity profiling, and method validation.
Our impurity synthesis services include:
- Synthesis and isolation of organic impurities
- Nitrosamine impurity synthesis per ICH M7 guidelines
- Structural elucidation using LC-MS/MS, NMR, FTIR, and UV-Vis
- Impurity qualification and toxicological evaluation support
These services are vital for regulatory submissions.
Contract Research and Manufacturing Services (CRAMS)
Topiox Research offers flexible CRAMS solutions that integrate custom synthesis, analytical testing, and process development.
Our offerings include:
- Custom synthesis of intermediates and specialty compounds
- Analytical method support and process validation
- Scale-up and technology transfer studies
- Secure, confidential project execution
This integrated model ensures faster development and consistent quality, from lab to pilot scale.
Complex Compound and Polymer Development
Our expertise extends to complex chemical compound synthesis and custom polymer synthesis, supporting pharmaceutical, cosmetic, and research industries.
We leverage advanced reaction design, purification systems, and analytical validation to ensure each synthesized compound meets global specifications.
Process Optimization and Scale-Up
Our process chemistry experts design and refine synthetic routes for optimal yield, efficiency, and environmental safety.
Key services:
- Reaction condition optimization and kinetic studies
- Green chemistry-based process improvement
- Scale-up from milligram to kilogram levels
- Process validation and technology transfer documentation
By bridging synthetic chemistry and analytical testing, we ensure reproducible, scalable, and cost-efficient processes.
Applications of Our Custom Synthesis Services
- Pharmaceutical API and Intermediate Development
- Impurity reference standard synthesis
- Process optimization and scale-up studies
- Regulatory documentation and method validation
- Analytical chemistry support for CMC submissions
- Development of specialty polymers and research chemicals
Quality, Compliance, and Regulatory Alignment
Every synthesis project at Topiox Research follows strict GMP-inspired and ICH Q7-aligned systems.
All materials undergo comprehensive analytical characterization using HPLC, LC-MS/MS, GC, NMR, and FTIR techniques.
We maintain full traceability, batch documentation, and electronic data integrity across all synthesis projects.
Each synthesized impurity or compound undergoes detailed Analytical Testing for purity confirmation, method validation, and regulatory documentation, ensuring data reliability for regulatory submissions.
Why Choose Topiox Research for Custom Synthesis Services?
Expertise in Custom and Chemical Synthesis
Our experienced team of synthetic chemists and analytical scientists specialize in API, intermediate, and impurity synthesis, ensuring precision, purity, and regulatory acceptance.
Recognized Among Leading Chemical Synthesis Companies
With a proven record of successful collaborations, Topiox Research stands among India’s most trusted custom chemical synthesis companies, delivering consistent quality and innovation.
Regulatory Alignment and Documentation
We ensure every synthesized impurity or compound complies with regulatory requirements, complete with audit-ready reports and spectral data.
Flexible CRAMS and R&D Models
We offer custom synthesis contracts, adaptable pricing, and short turnaround times, ideal for research organizations, generic manufacturers, and global pharma innovators.
Comprehensive Analytical Integration
Each synthesis project is backed by in-house analytical testing, method development, and stability studies, ensuring complete impurity and quality profiling.
Strategic Location and Global Reach
Based in Navi Mumbai, India, we provide cost-efficient synthesis and regulatory chemistry services to clients across the US, EU, and APAC regions.
Your Partner in Precision Chemical Synthesis At Topiox Research, we combine chemistry innovation with regulatory excellence to deliver world-class custom synthesis services. Whether for Excipient development, impurity synthesis, or polymer chemistry, our team ensures every project meets the highest standards of quality, accuracy, and compliance.
Frequently Asked Questions ( FAQs )
Custom synthesis involves the tailored preparation of APIs, intermediates, or impurities to meet specific research, analytical, or regulatory objectives.
Yes, we specialize in the synthesis of impurities, including Nitrosamines, to support impurity profiling, qualification, and method validation.
All projects follow GLP-based systems with clear milestones, from route design and synthesis to analytical verification and documentation.
Yes, our facilities support lab-to-pilot-scale synthesis, with process optimization and transfer to manufacturing partners as needed.
Our advantage lies in integrated analytical testing, regulatory alignment, and customizable CRAMS models that ensure precision, speed, and compliance.
Contact Topiox Research today to discuss your custom chemical synthesis requirements
At Topiox Research, we combine chemistry innovation with regulatory excellence to deliver world-class custom synthesis services. Contact us today to discuss your custom chemical synthesis requirements in Navi Mumbai, India.