To comply with FDA requirements, drug substances and drug products must comply with strict potency, purity, content uniformity, and rate of release specifications. Additionally, certain inactive ingredients in the drug product such as preservatives, anti-oxidants, and stabilizers must also be tested against specifications.
Vici develops and validates drug product test methods. Typical tests include:
- Potency assay to ensure compliance per label claim.
- In-process and finished product content uniformity assay to ensure control of quality during manufacturing.
- Impurity and API degradation product detection, identification, and qualification to ensure purity per ICH, industry standards, and FDA expectations.
- Dissolution methods to characterize drug release rate from the dosage form.
- Cleaning methods to ensure proper cleaning has been performed prior to manufacturing GMP clinical supplies.
- Preservative assay testing to ensure microbial purity.
- Nitrosamine impurities testing.
As per ICH guidelines and common industry practice, forced degradation is performed under stress conditions including acid, alkali, peroxide, heat, and UV exposure to ensure that methods are specific and stability-indicating.
Once methods are developed, phase-appropriate qualification or validation is performed per ICH standards to ensure compliance with FDA regulations. When feasible, compendial methods are utilized and methods are verified. Method validation protocols and reports are created and provided to the client or FDA as needed.
Method validation is performed to ensure the developed methods are suitable for QC testing and release of manufactured drug product for clinical and commercial use. Critical studies during validation include establishing:
- Limit of detection
- Limit of quantitation
Dissolution methods are developed to determine the rate of drug release over time under pre-selected, controlled conditions. Such methods are developed either for QC testing and release or specifically to aid formulation development. Vici typically performs the following:
- QC release testing using a USP Type I or Type II dissolution apparatus.
- Discriminating dissolution method development for formulation optimization and selection.
- Multi-media dissolution at various media to understand drug release at different pH.
- Alcohol dissolution testing to understand effect of alcohol on release rate of extended-release products.
Additional Testing Capability at Vici or Audited Third-Party Labs
- Optical, SEM, AFM and other microscopy to study particle size, shape and morphology
- XRD for drug substance polymorph characterization
- FTIR, IR, NMR, SEC, DSC, TGA and other analytical techniques through Vici’s collaboration with local universities
- Particle size analysis with laser diffraction
- Blend physical testing such as bulk and tap density, FLODEX® measurements
- Tablet physical properties such as hardness and friability
- Residual solvent testing using GC
- Extractable and leachable studies
- Microbial limit testing and AET
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Please contact us with any analytical testing needs you may have. We can act as consultants or perform tests in house.