Analytical Development
We understand your analytical objectives throughout the drug development process and work with you to ensure that appropriate methodologies are available at all stages. We offer support and trouble-shooting capabilities. We perform rapid development of analytical methods to support your formulation including assay, related substances and dissolution. Biotime develops, verifies and validates drug product test methods. We will support with finalization of analytical methods to support your registration and commercial drug product manufacturing.
Analytical Testing
We have extensive experience in the testing of drug products from development through to commercial drug products. We support excipient compatibility, finished product testing including related substances, dissolution, physical characterization and ICH stability testing of your drug products
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.
Cleaning methods to ensure proper cleaning has been performed prior to manufacturing GMP manufacturing
Dissolution methods to characterize drug release rate from the dosage form.
Preservative assay testing to ensure microbial purity.
Nitrosamine impurities testing.
Potency assay to ensure compliance per label claim.
ICH stability
Biotime offers full stability storage and testing service that satisfies ICH guidelines for the stability assessment of your drug products. Our fully validated, controlled and monitored
Stability storage includes-
- 25°C/60%RH
- 30°C/65%RH
- 30°C/75%RH
- 40°C/75%RH
