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BothTotal Organic Carbon ?643? and ?645? specifically state that these tests can be performed off-line or on-line. There are benefits and challenges for each approach (see 6.1 Purposes and Procedures and 7.1 Chemical Tests for Bulk Waters). In general, on-line testing avoids the risk of contamination of off-line samples by humans, containers, or the environment, and it provides immediate analysis and direct opportunities for real-time control, decision and intervention. For example, with on-line testing you can continuously test and accept the water as passing (for these chemical attributes). With this real-time analysis, you can prevent the utilization of the water in the event of a failed test result. Whether using on-line testing or laboratory analyses of grab samples, the tested water must be representative of the water used in production.▲(USP 1-Oct-2026)

TOC 〈643〉 和 〈645〉 都明確指出這些測(cè)試可以離線或在線進(jìn)行。每種方法都有優(yōu)點(diǎn)和挑戰(zhàn)（參見 6.1 目的和程序和7.1 散裝水的化學(xué)測(cè)試）。一般來(lái)說(shuō)，在線檢測(cè)避免了離線樣品被人員、容器或環(huán)境污染的風(fēng)險(xiǎn)，并為實(shí)時(shí)控制、決策和干預(yù)提供了即時(shí)分析和直接機(jī)會(huì)。例如，通過(guò)在線測(cè)試，可以（對(duì)這些化學(xué)屬性）進(jìn)行持續(xù)測(cè)試并放行水質(zhì)。通過(guò)這種實(shí)時(shí)分析，可以在測(cè)試結(jié)果失敗的情況下防止水的使用。無(wú)論是使用在線檢測(cè)還是對(duì)取樣進(jìn)行實(shí)驗(yàn)室分析，檢測(cè)水必須代表生產(chǎn)中使用的水?！?（USP 2026 年 10 月 1 日）

If microbial testing is needed for PC purposes, the sampling valve should have a properly installed, sanitary design that uses vigorous presampling flushing. This flushing shears off fragile biofilm structures growing on surfaces within the valve and water path before the sample is collected. This avoids biasing the microbial count of perhaps pristine water in the system behind that valve. A fully open valve flush [at greater than▲2.43 m/s▲(USP 1-Oct-2026)(8 ft/s)] velocity within the valve and connector for at least 30 s typically provides sufficient shear forces to adequately remove any fragile biofilm structures. Additional control measures for preventing sample contamination could also include stringent pre- and post-sampling outlet sanitation, the use of sterile hoses and gaskets or other connectors to direct the water flow, and other measures.

如果工藝控制需要進(jìn)行微生物檢測(cè)，則取樣閥應(yīng)采用正確安裝的衛(wèi)生設(shè)計(jì)，并使用強(qiáng)力的取樣前沖洗。在取樣之前，這種沖洗會(huì)剪掉生長(zhǎng)在閥門和出水管道內(nèi)表面的脆弱生物膜結(jié)構(gòu)。這避免了該閥門后面系統(tǒng)中可能原始水的微生物計(jì)數(shù)出現(xiàn)偏差。閥門和連接器內(nèi)完全打開的閥門沖洗流速[大于 ▲2.43 m/s▲ （USP 1-Oct-2026）（8 ft/s）]至少 30 秒，通常提供足夠的剪切力來(lái)充分去除任何脆弱的生物膜結(jié)構(gòu)。防止樣品污染的其他控制措施還可能包括嚴(yán)格的采樣前和采樣后出口清潔、使用無(wú)菌軟管和墊圈或其他連接器來(lái)引導(dǎo)水流以及其他措施。

▲If off-line measurement of conductivity is performed, there is no need to perform Stage 1 and Stage 2 in order. One can go directly to Stage 2 if off-line testing is preferred without first failing Stage 1.▲(USP 1-Oct-2026)

如進(jìn)行電導(dǎo)率的離線測(cè)量，則無(wú)需按順序進(jìn)行步驟 1 和步驟 2。如果首選離線測(cè)試，可以直接進(jìn)入步驟2，而不需要等步驟一失敗。▲（USP 1-Oct-2026）

7.5 Nitrosamines

亞硝胺

The presence of nitrosamines or their precursors in Purified Water and Water for Injection is directly related to their concentration in the starting water and the effectiveness of the water purification processes. A well-designed water purification system—utilizing softener, reverse osmosis, UV lamps, ion-exchange, distillation, etc.—will generally remove nitrosamine and contributing precursor impurities (e.g., ammonium, amines, nitrates, nitrites). Although no water system can guarantee the complete removal of nitrosamines and their precursors, a well-designed system should significantly reduce the risk of their presence or formation. Users can employ a control strategy by applying a risk-based approach to assess the potential presence of nitrosamine impurities in drinking water and the system's ability to remove them.

純化水和注射用水中亞硝胺或其前體的存在與它們?cè)谄鹗妓械臐舛群退畠艋に嚨挠行灾苯酉嚓P(guān)。設(shè)計(jì)良好的凈水系統(tǒng)——利用軟化器、反滲透、紫外線燈、離子交換、蒸餾等——通常會(huì)去除亞硝胺和產(chǎn)生前體的雜質(zhì)（例如銨、胺、硝酸鹽、亞硝酸鹽）。雖然沒有水系統(tǒng)可以保證完全去除亞硝胺及其前體，但設(shè)計(jì)良好的系統(tǒng)應(yīng)可以明顯降低它們存在或形成的風(fēng)險(xiǎn)。用戶可以通過(guò)應(yīng)用基于風(fēng)險(xiǎn)的方法來(lái)采用控制策略來(lái)評(píng)估飲用水中可能存在的亞硝胺雜質(zhì)以及系統(tǒng)去除這些雜質(zhì)的能力。