if we make injectable ampule solution accedently machain timing is out ampuling filling difficulte then who much the mention solution keep with nitrogen in sterile area
The bulk solution can be stored for a period based on “Hold time studies” of bulk injection solution under specified storage conditions. You must have conducted “Hold time studies” of this injection.
Is there any topic or chapter in USP or other pharmacopia about bulk injection solution ???
thank you sir
if hold time expired, can we do any test for ensuring that solution is ok after hold time?
yes why not, it should be test. what the bulk solution was contaminated? or any phychical or chemical change occured during the hold time