Analytical Development

Microbac provides comprehensive analytical support for NDA and ANDA submissions.  Examples include:

• Raw material and drug substance characterization.
• Analytical method development, validation and method technical transfer
• Solubility studies
• Bioanalytical Method development
• PK analytical support
• Development of analytical methods for API and finished product
• Dissolution Method development
• Residuals and Impurities testing (organic and inorganic)
• Cleaning Validation
• Extractables and Leachables
• Stability testing
• AET and Microbial Limit Validation
• Bacterial Endotoxin Validation