Hi,
Anvisa does not allow the use of Organic solvents for forced degradation study, however in case of BCS class 2 and Class 4 drug with poor aqueous solubility, we face issue with the recovery of API in Drug substance and drug product, leading to low Assay value, any suggestions on how do we expose the sample for degradation , is there any other option to get the recovery.
We used acetonitrile / water for forced degradation studies. ANVISA will adhere to the ICH/EMA guidelines and ease those restrictions. ANVISA RDC 53 (2015) Article 4 states that:
"Before using organic solvents, it is recommended to discuss the possibility of a certain solvent reacting with the product, generating products that are not compatible with real conditions.
Regarding the use of organic solvents after exposure, in sample preparation for analysis, it is recommended to check its miscibility in the solution resulting from the exposure / neutralization process. It should be noted that some water-miscible solvents, such as acetonitrile, may not be in concentrated alkaline or saline solutions."
Use 0.1 M KOH for alkaline conditions; the regulations are vague about concentrated alkaline solutions.
- Badges
- Science topic
- Similar topics
- Force