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Writer's picturePharmaceutical Guideline

STERILE PURIFIED WATER


Sterile Purified Water is Purified Water,

packaged and rendered sterile. It can be used in the preparation of nonparenteral compendial dosage forms or in analytical applications requiring Purified Water where...

[1] access to a validated Purified Water system is not practical,

[2] only a relatively small quantity is needed,

[3] Sterile Purified Water is required by specific monograph or pharmacy practice, or

[4] bulk packaged Purified Water is not suitably controlled for the microbiological quality for its intended use.









 



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