Analytical Services
Understanding Analytical Services in Pharmaceuticals
At Aquigen Bio Sciences, Quality Control and Analytical Services are an integral part of our Pharmaceutical Development and Manufacturing Processes. Structural Identification, Purity Analysis and Stability Testing are indispensable for evaluating a molecule’s properties such as Molecular Structure, Weight, Stereochemistry, and Degradation Patterns over time. Our Analytical Chemistry Department is equipped to provide these critical Analytical Services.
As a client-focused organization, we are committed to maintaining strict confidentiality for all of our analytical projects. In addition, we welcome on-site audits so clients can independently verify the quality of our Analytical Laboratory and capabilities. With strengths in both Organic Synthesis and Analytical Techniques, Aquigen Bio is a trusted partner for pharmaceutical analytical needs at any stage of development.
“Regulatory bodies like FDA mandate Quantitative and Qualitative analytical data submission from early stages of research through commercial production.”
Range of Analytical Services By Aquigen Bio
Range of Analytical Services By Aquigen Bio
Spectrometric Techniques
At Aquigen Bio, we recognize the importance of Spectrometric techniques in compound characterization and structure elucidation. Our LC-MS and GC-MS systems enable the separation of compounds based on Polarities and Volatilities, respectively.
Each unique component is then identified by its retention time on the chromatogram. More definitive structural information is obtained through mass fragmentation patterns generated by the mass spectrometers. This allows deduction of molecular weight as well as structural features like functional groups.
With our LC-MS and GC-MS instruments operated by highly skilled Analytical Chemists, we can rapidly characterize Impurities, Metabolites and other unknown species to further Pharmaceutical Research and Development.
Chromatography
Liquid and Gas Chromatography instruments with detectors like UV, RI, FID/TCD facilitate Quantitative and Qualitative Analysis of compounds through retention behavior enabling impurity profiling, method development and quality testing. At Aquigen Bio, we provide Chromatography HPLC (3 no.’s UV, RI, CAD), GC (1 No.), UPLC (1 No.)
Preparative Chromatography
Preparation Liquid Chromatography system with fraction collection helps isolate milligram quantities of pure compounds from mixtures for further structural analysis through NMR, Crystallography etc. At Aquigen Bio, we provide Preparative Chromatography- Dual mode (auto or manual collection, 1 No.)
Wet Analysis
Autotitrator determines acid/base and redox properties. Conductivity meter analyzes ion concentrations and purity of electrolytic solutions. KF titrator quantifies water content in liquids and solids. At Aquigen Bio, we provide Wet Analysis- Autotitrator (1 No.), Conductivity (1 No.), KF Tritrator (1 No.).
Thermal Studies
Thermal analysis techniques such as DSC, TGA and melting/boiling point measurements provide important information about compound's Thermal Stability, Purity and Phase transitions essential for developing synthesis and solid-state shelf life. At Aquigen Bio, we provide Thermal Studies- DSC (1 No.), TGA (1 No.), Melting Point and Boiling Point (1 No.).
FAQs About Analytical Services
What is the need for Analytical Services in Drug Development?
Analytical Services play an integral role throughout the drug development process. From the initial research phases, chemical characterization of novel compounds is necessary to elucidate structure-activity relationships and inform synthesis approaches. As development progresses, Analytical testing is critical to support scale-up validation and ensure batch quality. It is also vital for comprehensive safety evaluation through impurity, degradation and metabolite profiling. Robust analytical methods and capabilities are essential for comparative formulation analysis and demonstrating manufacturing consistency for regulatory approvals.
Benefits of Analytical Services for Drug Development
Why Aquigen Bio is a top choice for Analytical Services?
Aquigen Bio has distinguished itself as a leading provider of Analytical Services due to its best-in-class capabilities and strong track record. We have extensive experience in method development and validations for a wide range of organic molecules. Aquigen’s Analytical department is equipped with advanced instrumentation, operated by highly skilled scientists. Being integrated with the company’s synthesis and process development operations allows for superior turnaround times. Aquigen also offers value-added services such as impurity isolation and structure elucidation. Our Analytical excellence and client-centric approach have created an excellent reputation in the industry. Get in touch with us!