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Pharmaceutical Guideline
Pharmacopoeia

Nonmonographed Waters

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

Pharmaceutical Guideline1 min read
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Two girls drinking glasses of water at a wooden kitchen table

Two girls drinking glasses of water at a wooden kitchen table

Nonmonographed Waters: In addition to the bulk monographed waters described in the article https://www.pharmaceuticalguideline.com/post/waters-used-for-pharmaceutical-manufacturing-and-testing-purposes, non-monographed waters can also be used in pharmaceutical processing steps such as cleaning and synthetic steps, and also as a starting material for further purification or testing purposes. Unless otherwise specified in the compendium, the minimum quality of water is Purified Water.

[NOTE—The information in this the chapter is not an all-inclusive discussion of all non-monographed waters identified in the USP–NF.]

Two girls drinking glasses of water at a wooden kitchen table

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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.

Pharmacopoeia

STERILE PURIFIED WATER

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

Pharmacopoeia

DEIONIZED WATER

Deionized Water is produced by an ion-exchange process in which the cations & anions are replaced with H+ & OH− ions by use of ion-exchange