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Pharmaceutical Guideline
Pharmacopoeia

STERILE PURIFIED WATER

Sterile Purified Water is Purified Water, packaged and rendered sterile.

Pharmaceutical Guideline1 min read
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500 mL bottle labelled Sterile Purified Water, reverse osmosis purified and UV-treated, with the Pharmaceutical Guideline logo

Sterile Purified Water is Purified Water,

500 mL bottle labelled Sterile Purified Water, reverse osmosis purified and UV-treated, store at 2 to 30 °C, not for human or animal consumption, with the Pharmaceutical Guideline logo

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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Pharmacopoeia

SOURCE WATER CONSIDERATIONS

Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.

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Nonmonographed Waters

These waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.

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Sterile Monographed Waters

Sterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized