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Nanjing Tianshui Machinery Equipment Co., Ltd
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Nanjing Tianshui Machinery Equipment Co., Ltd

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    13770985289

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    190 Bianzhong East Road, Chengqiao Town, Nanjing City

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Pharmaceutical purified water equipment supplier

NegotiableUpdate on 02/24
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Overview
Pharmaceutical purified water equipment suppliers purify water as pharmaceutical water prepared by distillation, ion exchange, reverse osmosis, or other suitable methods for drinking water. It does not contain any additives and its quality should comply with the regulations under the purified water section of Part II.
Product Details

  Medicinal purified water equipmentRequirements for water testing

Purified water is pharmaceutical water prepared by distillation, ion exchange, reverse osmosis, or other suitable methods for drinking water. It does not contain any additives and its quality should comply with the regulations under the purified water section of Part II. Purified water can be used as a solvent or experimental water for preparing common pharmaceutical preparations; Can be used as an extraction solvent for medicinal herbs used in sterilization preparations such as traditional Chinese medicine injections and eye drops; Solvents or diluents for the preparation of oral and topical preparations; Clean water for non sterile utensils. It is also used as an extraction solvent for medicinal herbs used in non sterile preparations. Purified water shall not be used for the preparation of injections and diluents. There are multiple methods for preparing purified water, and strict monitoring of each production process should be carried out to prevent microbial contamination. Used as a solvent, diluent, or washing water, it should generally be prepared before use.

The testing items required for purified water in the Chinese Pharmacopoeia include: pH, chloride, sulfate, calcium salt, nitrate, nitrite, ammonia, carbon dioxide, easily oxidizable substances, non-volatile substances, and heavy metals, totaling 11 items.

Among them, detection methods were established for nitrate and nitrite respectively. The limit of bacterial endotoxins in injection water has also been reduced to 025EU/ml.

One major change in the testing standards for pharmaceutical water in the United States Pharmacopeia is the removal of numerous testing items and their replacement with Total Organic Carbon (TOC) testing and conductivity.

When the total organic carbon content is low enough, it can ensure that the content of numerous microorganisms or endotoxins is low enough, and online detection methods can be used for real-time continuous monitoring. This advantage is crucial in the production process.