Antiviral API Analysis Service
The production of antiviral APIs often involves complex chemical and biological changes. Since the production process is developed based on chemical unit reactions and chemical unit operations, which can generate by-products. Therefore, API purification and refinement are necessary. Impurity (e.g. API-related substances, residual organic solvents and inorganic impurities) control, physical and chemical property characterization and analysis of APIs, API stability studies, contamination and cross-contamination analysis are key considerations regarding the quality, safety and efficacy of antiviral APIs.
BOC Sciences offers a full suite of analytical services for antiviral APIs including impurity identification and isolation, as well as quality studies and stability testing.
API Analytical Services
- We have established a systematic method screening system that enables rapid establishment of consistently indicated assays and impurity methods using UPLC-MS and solvent screening
- Our teams have established well-defined impurity control strategies and specifications, including:
- Chiral impurity/purity methods establishment by employing UPC2 or HPLC
- Method development for counter-ion analysis by using titration or IC
- Impurity structure identification by NMR, UV, IR, TGA, DSC, HRMS, etc
- Sample preparation by SFC or prep-LC with full characterization
- Establishment of analytical methods for (potentially) genotoxic impurities by LC-MS or GC/MS including GC-MS/MS
- Establishment of analytical methods for elemental impurities in compliance with ICH Q3D (ICP-MS) standards
- We can develop analytical methods for no-UV response compounds using CAD or RID
- Rapid method development and determination of compound-specific residual solvent and water content by gas chromatography system and KF analyzer
Figure 1. Analytical method lifecycle. (Weijun, L. 2019)
- Antiviral API impurity research
Our API impurity profiling team employs a variety of techniques to determine metal impurities in antiviral APIs. Our methodologies include inductively coupled plasma mass spectrometry (ICP-MS), inductively coupled plasma optical emission spectrometry (ICP-OES), and graphite furnace atomic absorption spectrometry (GFAAS).
- Preparation and standardization of API impurities/standard samples
- Impurity studies and impurity profiling
- Antiviral API quality studies
- Physical and chemical properties:
- Chromatographic purity of APIs
- Spectral characterization (IR, UV-vis, fluorescence, MS)
- Dissociation constants (pKa)
- Particle size and morphology (laser diffraction, microscopic imaging)
- Density (bulk and fractionated)
- Crystallinity (x-ray diffraction)
- Thermal analysis (melting point and glass transition)
- Solubility studies in organic and pharmaceutical solvents
- Excipient compatibility studies
- Material compatibility studies (contact parts, packaging materials)
- Forced degradation studies (heat, acid, base, light, peroxide, metal ions)
- Impurities control (related substances, residual solvents, genotoxic impurities, elemental impurities and chirality)
- Content analysis
- Structure elucidation & confirmation
- API inspection and release
- Central control analysis
- Validation of analytical methods (HPLC, chiral HPLC, GC-HS)
- Antiviral API stability management & testing
- Stability indicating method validation & transfer
- Preparation of stability protocol
- Sample management & testing
- Data & trend analysis & preparation
- Analytical training, documentation & internal audit
- Influencing factors (1 month)
- Accelerated stability (6 months)
- Long-term stability (tentative 24 months)
Why Partner with BOC Sciences?
- We apply our years of proven expertise and experience in antiviral drug development to improve the success of your program
- Our continuously updated facilities support a range of antiviral drug analysis and manufacturing services
- BOC Sciences' experienced team of scientists and regulatory staffs are focused on working with our clients to deliver timely and high-quality small molecule antiviral drugs
- Our partnerships with leading experts in emerging technologies allow us to apply innovative solutions to your antiviral drug research programs
Reference
- Manin, A. N.; et al. Crystal Structures, Thermal Analysis, and Dissolution Behavior of New Solid Forms of the Antiviral Drug Arbidol with Dicarboxylic Acids. Crystals. 2015. 5. 650-669.
- Weijun, L. Points to Consider in Quality Control Method Validation and Transfer. BioProcess International. 2019.
※ Please kindly note that our services are for research use only.
