Hi,
What are the ASTM or ISO standards to be followed for the above ... ASTM F 1980 or ISO 11607 OR both ?
Has the stability studies to be done at higher temperature AND Humidity OR only higher temperature.
what should the ambient temperature be taken as ... it can vary from say 15 to 40 degree ( centigrade ) ... or do we need to do study at 15 and 40 deg. temperature
Any help would be appreciated.
Thanks
michelle
What are the ASTM or ISO standards to be followed for the above ... ASTM F 1980 or ISO 11607 OR both ?
Has the stability studies to be done at higher temperature AND Humidity OR only higher temperature.
what should the ambient temperature be taken as ... it can vary from say 15 to 40 degree ( centigrade ) ... or do we need to do study at 15 and 40 deg. temperature
Any help would be appreciated.
Thanks
michelle