At Chalcogen Pharma, we specialize in custom synthesis of reference standards, pharmaceutical intermediates, active pharmaceutical ingredients (APIs), and impurities to support drug development, research, and regulatory compliance. With our expertise in synthetic organic chemistry and state-of-the-art laboratories, we provide high-quality, scalable, and cost-effective solutions tailored to meet the unique requirements of pharmaceutical, biotech, and research organizations.
We offer a comprehensive range of custom synthesis services to support various stages of drug development and analytical research. Our focus is on precision, reliability, and regulatory compliance, ensuring that every synthesized compound meets the highest quality and purity standards.
We provide custom synthesis of reference standards required for analytical method development, validation, and quality control in pharmaceutical research. Our synthesized standards meet USP, EP, BP, and JP pharmacopeial specifications and are supplied with detailed characterization data such as NMR, HPLC, MS, and COA (Certificate of Analysis).
Our expertise in synthetic route development and optimization enables us to manufacture high-purity pharmaceutical intermediates required for drug synthesis. We support projects from milligram to multi-kilogram scale, ensuring cost-effective production while adhering to GMP guidelines for regulatory compliance.
We provide custom API synthesis services, offering small to large-scale manufacturing solutions for both novel and generic APIs. Our API development process includes route scouting, process optimization, impurity profiling, and regulatory documentation support, ensuring a seamless transition from R&D to commercial production.
Identifying and characterizing impurities is crucial in pharmaceutical research. We offer custom synthesis of known and unknown impurities, degradation products, metabolites, and stable isotope-labeled compounds. Our impurity profiling services help pharmaceutical companies comply with ICH guidelines (ICH Q3A & Q3B) and meet regulatory submission requirements.
Our custom synthesis solutions cater to a broad range of industries, including:
Pharmaceutical & Biotech Companies – Supporting drug discovery, development, and commercialization.
Contract Research Organizations (CROs) – Delivering high-quality standards, intermediates, and impurities for clinical trials.
Analytical & Quality Control Laboratories – Providing reference materials for method validation and regulatory compliance.
Academic & Research Institutions – Assisting in drug discovery and chemical research projects.
Partner with Chalcogen Pharma for high-quality, cost-effective, and reliable custom synthesis of reference standards, intermediates, APIs, and impurities. Our commitment to precision, compliance, and client satisfaction ensures that you receive the best-in-class solutions for your pharmaceutical and analytical research needs.
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