Botanical Analytics
Process development for isolating small and large molecules from plants
Development of HPLC methods tailored for botanical APIs and products
Application of high-resolution mass spectrometry to infer the structure of botanical ingredients/APIs
Confirmation of ingredient structures using botanical reference standards
Utilization of infrared spectroscopy, ultraviolet spectroscopy, mass spectrometry, and nuclear magnetic resonance, for determining structures of unknown ingredients
Analytic testing to ensure botanical API and product quality and compliance.
Certificates of analysis for botanical drug substances and products
Stability studies in accordance with ICH guidelines
Botanical Reference Standards
Over the past decade, through collaboration with world-class research institutes, we have built a comprehensive reference library of botanical ingredients through a process of: 1) dividing each herb into 4 to 8 parts, 2) performing High-Performance Liquid Chromatography (HPLC) on these segments to detect and isolate individual ingredients.
As a result, we have established over 10,000 botanical ingredient standards. Each standard is dosed at 20 mg per vial, ensuring a purity level of over 98%, as verified by High-Performance Liquid Chromatography (HPLC).
Leveraging this extensive library of these Botanical Ingredient Standards, ABDC can identify many unknown ingredients in your botanical products. Identifying these unknown ingredients is crucial for your product research and development and may also be required for FDA botanical IND filings.
An example is below:
