General Reference: Analytical Methods in Cleaning Validation (10)
Method | Specificity | Able to Detect | Cost | |||
---|---|---|---|---|---|---|
API | Excipients | Cleaning agents | Waste/Biopharmaceuticals API | *: LOW*****: HIGH | ||
HPLC | yes | yes | yes | yes | **** | |
TLC | yes | yes | yes | ** | ||
TOC | yes | yes | yes | yes | yes | *** |
Spectrophotometry | yes | yes | yes | yes | ** | |
pH | No | yes | * | |||
Conductivity | No | yes | * | |||
Gravimetric | No | yes | yes | * | ||
ELISA | yes (BIO) | yes | ***** | |||
Electrophoresis | yes (BIO) | yes |