As one of the leading chemical impurities suppliers, Puresynth Research Chemicals GmbH provides a wide range of pharmaceutical impurities, degradation products, and reference standards that meet the highest analytical and regulatory standards. Our impurity standards are synthesized and characterized with proven accuracy to support method validation, stability studies, and impurity profiling. With a strong focus on high-purity chemical synthesis and traceability to international references, Puresynth ensures every product enhances precision and reliability in analytical testing. Trusted by laboratories worldwide, including in India and Germany, we help researchers maintain quality, compliance, and scientific confidence in every analysis.
Our Comprehensive Range of Impurities & Intermediates
We offer a complete portfolio of impurities and intermediates designed to support pharmaceutical R&D, bioanalytical testing, and process development.
Process-Related Impurities:
Identifying & Supplying Critical By-Products
Our impurities supplier network provides authenticated process-related impurities essential for impurity profiling and stability testing. These materials help researchers identify potential degradation pathways and comply with regulatory guidelines.
Drug Metabolites:
High-Purity Standards for ADME & Bioanalysis
We supply metabolites that mirror in-vivo drug transformation products, assisting in ADME and bioequivalence studies. Each metabolite undergoes multi-level quality checks to ensure structural confirmation and consistent purity, enabling accurate pharmacokinetic and toxicological assessments.
Chemical Intermediates:
Key Building Blocks for API Synthesis
Our intermediates play a vital role in the synthesis of active pharmaceutical ingredients (APIs). As reliable chemical impurities suppliers, we maintain a ready inventory of critical intermediates that meet global pharma manufacturing standards—supporting projects from laboratory to pilot scale.
Custom Impurity Syntheses:
Tailor-Made Solutions to Your Specification
Need a specific impurity or intermediate not available in the catalog? Our R&D team specializes in custom synthesis of impurities and metabolites tailored to your compound’s structure and analytical requirements. From milligrams to multi-gram quantities, we deliver precision-made solutions on time.
Why Choose Us as Your Impurities Supplier
Partnering with the right impurities’ supplier ensures your research and regulatory compliance stay on track. Here’s why our clients trust us globally:
•➤ Regulatory Compliance & Analytical Support
- Every product is designed to align with impurity guidelines. We offer full analytical data packages—including NMR, MS, and chromatographic purity reports—to support your regulatory submissions.
•➤ Quality Assurance: Certificates of Analysis, Batch Traceability
- Our chemical impurities supplier operations follow strict GMP and ISO 9001 standards. Each batch is traceable and accompanied by a Certificate of Analysis (CoA), ensuring you receive verified and reproducible quality.
•➤ Global Supply Chain: On-Time Delivery & Worldwide Shipping
- With a well-structured supply network, we deliver metabolites and intermediates globally—reaching research facilities, CROs, and pharmaceutical companies with reliability and speed.
•➤ Technical Expertise: R&D Collaboration and Custom Solutions
- Our scientists collaborate directly with your R&D teams, providing synthesis design, analytical method development, and impurity reference material solutions to fit your specific project needs.
Applications
How Our Metabolites & Intermediates Support Your Projects
Pharmaceutical R&D & Drug Discovery Workflows
Our intermediates and metabolites are integral to early-stage R&D, supporting compound optimization, impurity identification, and target validation.
Stability Studies, Degradation Pathway Analysis & Impurity Profiling
As one of the most experienced chemical impurities suppliers, we assist clients in performing detailed impurity profiling and degradation studies—ensuring compliance with regulatory guidelines.
Scale-Up & Manufacturing Support: From mg to kg Supply
From research scale to pilot production, our scalable supply solutions make it easy to move your project from discovery to commercialization without compromising on quality or lead times.
Bioanalytical & ADME Studies: High-Purity Metabolite Standards
Our metabolites are designed to provide high analytical reproducibility for ADME and bioanalysis workflows, helping researchers generate accurate data for pharmacokinetic modeling.
Our Process : From Request to Delivery
•➤ Initial Inquiry & Requirement Definition:
We start by understanding your specific impurity or intermediate requirements—structure, purity, and quantity.
•➤ Specification Review, Structure & Purity Confirmation:
WOur R&D team reviews all data to confirm the molecular structure and analytical feasibility of the requested impurity or metabolite.
•➤ Production, Quality Testing & Certificate of Analysis (CoA):
WOnce synthesis is complete, each batch undergoes rigorous testing and characterization to guarantee the highest purity standards expected from a professional impurities’ supplier.
•➤ Packaging, Logistics & Global Export Considerations:
Secure packaging and temperature-controlled shipping ensure the safe delivery of sensitive chemical impurities, metabolites, and intermediates to your location—worldwide.
Supplier Partnerships & Custom Solutions
•➤ Contract Synthesis & Custom Impurity Projects
We provide custom impurity synthesis and intermediate manufacturing to meet your unique compound specifications, ensuring accuracy and confidentiality throughout.
•➤ Dedicated Account Management & Technical Support
Our clients benefit from a single point of contact for technical and commercial coordination, simplifying communication from start to finish.
•➤ Confidentiality, IP Protection & Project Flexibility
We strictly protect intellectual property and maintain complete confidentiality on every project, making us a reliable chemical impurities supplier for sensitive R&D collaborations.
•➤ Cost-Effective Sourcing & Competitive Pricing Models
We balance quality with affordability, offering flexible pricing options without compromising product integrity or turnaround time.