Updating international standards for pharmaceutical waters

Other wet chemistry tests for screening classes of impurities included oxidizable substances, heavy metals, and p H.

These tests complemented other existing tests for particulates, micro-organisms, and endotoxins.

These measurements were primarily used to verify that the water purification equipment specification was met.

The technical group leaders at Ph RMA and USP realized the potential to take advantage of these process analytical measurements and use them for greater and more productive means.

Historically, quality tests for bulk purified water (PW) and water for injection (WFI) were confined to the laboratory.

Water samples were checked for single chemical impurities using traditional wet chemistry methods.

As far back as 1989, the United States Pharmacopoeia (USP) and the Pharmaceutical Research and Manufacturers of America (Ph RMA) began investigating alternatives to the wet chemistry tests.

updating international standards for pharmaceutical waters-12

At that time, the principal focus was not on the water, but on the reliability of the water testing.IP contains a collection of authoritative procedures of analysis and specifications of drugs for their identity, purity and strength.The standards of the IP are authoritative in nature and are enforced by the regulatory authorities for ensuring the quality of drugs in India.The potency of these preparations is expressed in International Units.Analytical Research and Development (AR&D) Division firmly reinforces the mission and vision of IPC by bringing highest standards of drugs through its dynamic research activities.

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