Can anyone share me the updated guidelines of the specification of different pharmaceutical wateras per BP. USP, EP, JP and IP
The acceptable grade of water will depend heavily on the
stage at which it is to be used during manufacture.
For Synthesis of all intermediates of APIs prior
to final isolation and purification steps No requirement for sterility or apyrogenicity in API or
the pharmaceutical product in which it will be used, potable water is minimum acceptable quality of water.
For Final isolation and purification : API is not sterile, but is intended for use in a sterile,
non-parenteral product, Purified water is minimum acceptable quality of water.
1 Like