-
- Posts: 1
- Joined: Thu Jul 26, 2018 2:09 pm
One of my drug product is having lambda max 205 nm, for related substances method, I have selected 210 nm wavelength. But there are multiple peaks in the sample due to Placebo.
My queries are as follows on related substances method,
1. Is it acceptable to have multiple peaks in drug product due to placebo?
2. Once the product transfer to plant, are they (QC) need to inject placebo every time?
3. If yes to point no.2, does the Placebo also need to be kept for stability along with drug product batches?
4. Does the change in batch of excipients, will also trigger for new placebo with respective material?
5. Does the one time injection of placebo at the time of method transfer will suffice throughout the stability studies?
Note: All the placebo peaks are well separated from known or unknown peaks.
Thanks and Regards
Ravin