The Chinese Pharmacopoeia 2025 has introduced significant revisions to the 9101 Guidelines for Validation of Analytical Methods further promoting the application of statistics in analytical method validation.
Sodium bicarbonate has been used clinically for over 200 years. Sodium carbonate was originally used as an antacid to neutralize excessive gastric acid.
A recently published paper suggests the test panel of micro-organisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.