ASTM E2656-25 药用水总有机碳属性的实时释放测试(中文)

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3.0 51zlzl 2025-11-27 73 2.6MB 8 页 80质量币

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of

International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.

󳬎󶃱󾘛E2656-25

󳤷󶩰󵰩󵌵󴜼󴸊󴸻󵾴󴍟󴜨󴊟󴳷󴰿󶽍󴿁󵑌󵶅󴼈󳣇󴯎󳙝󷃅󶄌

󴸭󴼈󳣇󳗦󳷻󴊛󶘗󳫸 E2656 󳫒󴔄󾘜󶘗󳫸󶐨󷶐󳡷󳬏󵶅󴱱󴉘󶽩󶀻󴸁󳤞󷣈󵰩󵶅󴕵󳗾󾘍󴂃󳔻󳛯󷊣󵥉󾘍󳤚󶽩󶀻󴸁󷛒󳔁󵈢󳛯󷊣󵶅󴕵

󳗾󱜃󴧭󳫸󳢆󵶅󴱱󴉘󶽩󶀻󴸁󷛒󳔁󵈢󷣎󴲱󴥺󳣇󵶅󴕵󳗾󱜃󳔋󴼈󴉘󵋎  󶽩󶀻󶣫󳔋󵈢󳛯󷊣󴤗󷣎󴲱󴥺󳣇󳗦󴹦󳗆󳝛󳖇󶘗󷚒󴜨󳛯󴰺󱜃

1.󶨄󳷵

1.1 󴸭󷃅󶨄󵽯󶇌󳖇󳔁󶃎󳻻󳖏󴜼󴸊󴸻󵾴󾘉TOC󾘊󴍟󴜨󾘍󷣈

󵰩󳸩󶗀󴜼󴸊󴸻󵾴󾘉OLTOC󾘊󳗫󳵩󴋺󳤷󶩰󵰩󵌵󷛜󶽍󴊟󴳷󴰿

󶽍󴿁󵑌󾘉RTRT󾘊󵶅󴲺󵏖󾘍󷋦󴲺󵏖󶈧󳬉󴙔󳥎󵶅󵷒󶊢󴜞󷓰󱜃

1.2 󴸭󴊟󷓶󳔏󶚏󳷾󴹑󴲚󳔏󷋖󸆍󳩐󳘛󳷾󷵆󴃕󳭙󳘛 E55 󳤷

󶩰󳖨󳯂󳤷󷜡󴼈󳣇󱜂ICH 󳔊󴲺󳩐󷌄󴨈󳩘󱜂󶚏󳷾󷿠󳯂󶩰󳯂󵷒

󵹤󶊢󵬇󴍁󾘉FDA󾘊󵶅 PAT 󴨈󳩘󳗦󳫋󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢

󵬇󴍁󶩰󳯂󵪱󶽍󶥰󴁾󵰠󳖨󷃅󶨄󾘉CGMP󾘊󵶅󵬇󴛶󵷹󳩐󷌄󴤗

󳖉󳗦󴰰󴨂󱜃

1.3 󴸭󷃅󶨄󳔎󴫑󳚜󳤷󶩰󶽍󳔛󳔮󶾬󷃇󳔻󴼈󳣇󴯎󳙝󵶅󳤷󶩰󶄌

󴖐󵶅󳔁󶤭󴜨󴨈󴋽󳛢󴝰󱜃󴸭󷃅󶨄󳔻󷹟󴼈󳣇󳨗󶄌󴖐󴫑󳚜󳡸󳙔

󴨈󴋽󱜃

1.4 󴸭󷃅󶨄󳔎󵒊󳫋󵰩󴤸󳢆󷟩󴸊󳡴󷿏󷵪󱜂󳫙󴷵󴤗󷐩󷣐󶊢󵬇

󳙔󶏼󵶅󳬅󶃎󶄌󴖐󱜃󳔏󴸭󷃅󶨄󵷹󳡴󵶅󴱵󳙔󷽺󵷯󴓦󳙝󷣐󴖕󳔏

󳤷󶩰󵰩󵌵󴜼󴸊󴸻󵾴󾘉TOC󾘊󵑔󴖧󷃅󴼽󳔎󳬉󴼽󵶅󴜼󳙔󷿏󷵪

󴤑󵋕󳚌󱜃

1.5 󴸭󴊟󷓶󴕷󳔎󴳩󳸩󷃅󴊛󴂃󳙖󶈧󳬉󶩰󳡹󵶅󷂂󵍃󱜃󴥁󷜊󵶅

RTRT 󴲺󵏖󴛆󷽼󵽯󳛞󶈧󳬉󵰩󴤸󴙔󳥎󷜃󵰩󵶅󶩰󳡹󷂂󵍃󱜃󵠷

󶜍󾘍󶈧󳬉󶩰󳡹󳔮󴜼󴸊󴸻󵾴󾘉TOC󾘊󴲺󵏖󵶅󷂂󵍃󴕷󳔎󳔁󴊛

󷒴󳗦󵗢󷒴󴙔󳥎󴋺 RTRT 󵶅󵷒󶊢󴸠󴸜󱜃

1.6 󴸭󴯎󳙝󷃅󶄌󴳡󴠐󴸀󳗤󴤗󳫗󳗤󶩰󳡹󳔮󴸊󳡴󴚯󵰠󵥪󷐠󷙾

󴿁󵑌󵶅󷂂󵍃󱜃󳡷󳗆󷜃󵰩󳖏󵌵󷐩󵶅󴜼󴸊󴸻󵾴󾘉TOC󾘊󴍟

󴜨󱜃

1.7 󴸭󴼈󳣇󴳡󴠐󵒶󵷗󳡷󳚀󵰩󷛈󶄌󳔮󳫰󶟾󴉙󳸩󵶅󴥁󴸊󴊊

󳡩󷳯󷾙󾘉󴂃󴸊󾘊󱜃󴸭󴼈󳣇󳚀󵰩󶜆󴸊󷐤󳗼󳸩󳚀󵰩󳥎󴗻󶇌󷜃󴙔

󵶅󴊊󳡩󱜂󳝦󴖸󳮍󵪰󳾄󷃅󶨄󾘍󴕷󵽯󴊛󷜃󵰩󵶅󵏖󷃅󷵑󳤷󱜃

1.8 󴸭󳷾󷵆󴼈󳣇󴴰󳚞󴩯󳔗󵱍󷐹󴴔󶗅󶗈󴦁󴸰󴜨󷐹󴴔󳿂󳺓

󴃕󳭙󳘛󳫒󴔄󵶅󱜋󳡴󳖏󳤷󴊛󳷾󷵆󴼈󳣇󱜂󴨈󳩘󳮍󴗻󷊯󵶅󳪠󳤚󵶅

󳢴󴊛󱜌󳔮󵽯󶇌󵶅󳷾󷵆󳡭󷊥󴼈󳣇󳨗󳪠󳤚󳤷󴊛󵶅󱜃

2.󳫃󶜄󴲈󳗷

2.1 󶚏󳷾󴹑󴲚󳔏󷋖󸆍󳩐󳘛󴼈󳣇󾘛

E2281 󷛈󶄌󶟾󳦜󳮍󴜨󶟾󵑌󷣐󴊟󴲾󷃅󶄌

E2363 󶩰󳯂󳮍󵰠󵥪󶩰󳯂󳤷󷜡󳔛󴸰󷋮󾘉󷜃󵰩󳖏󳤷󶩰

󳮍󵰠󵥪󳤷󶩰󶽍󳔛󾘊

E2500 󶩰󳯂󳮍󵰠󵥪󶩰󳯂󵰠󳖨󶏼󶗠󳫋󷊿󴀈󵶅󷃅󴼽󱜂

󷊿󷊢󳮍󸆍󷋂󴨈󳩘

E2537 󶩰󳯂󳮍󵰠󵥪󶩰󳯂󵰠󳖨󳔮󷛟󶗮󴓦󶥻󸆍󷋂󴖕󵰩

󴨈󳩘

D4839 󵌵󳔮󴜼󵾴󳮍󴸊󴸻󵾴󵶅󵑌󴊛󴲺󵏖󾘛󷣈󵰩󶐬󴀗

󶗀󴤗󷛈󵽬󷡹󵷑󵌨󳨗󴤗󳔥󶜆󳡽󵰩󾘍󳗦󳫋󶖣󴀗󴿁󵑌󵏖

D5173 󵌵󳔮󴜼󴸊󴸻󵾴󳸩󶗀󵷒󵑌󵌨󳨗󵰠󴤑󳖍󵌨󳨗󵾴

󴿁󵑌󴨈󳩘

D5904 󵌵󳔮󴜼󵾴󱜂󴳡󴸻󵾴󳮍󴸊󴸻󵾴󵶅󵑌󴊛󴲺󵏖󰜕󰜕

󶐬󴀗󶗀󱜂󷛈󵽬󷡹󵷑󵌨󳨗󳫋󶢝󵰶󴋽󴿁󵑌󵏖D5997 󵌵󳔮󴜼

󵾴󱜂󴳡󴸻󵾴󳸩󶗀󵷒󵑌󴲺󵏖󰜕󰜕󶐬󴀗󶗀󱜂󷛈󵽬󷡹󵷑󵌨󳨗

󳫋󶢝󵰶󴋽󴿁󵑌󵏖

󵌵󳔮󴜼󵾴󱜂󴳡󴸻󵾴󳮍󴸊󴸻󵾴󵶅󳙏󳬬󷣐󵑌󴊛󴲺󵏖󰜕󰜕

󷣈󵰩󶐬󴀗󶗀󱜂󷛈󵽬󷡹󵷑󵌨󳨗󳮍󶢝󵰶󴋽󴿁󵑌󵏖󾘉D6317󾘊

󵥉󴹄󴥁󴸊 OASTM 󳷾󷵆󾘍󳸱󳹁󾘛100 󴓵󴌕󵔰󷓰󾘍󷞯󴱀󳛢󶊲 C700󾘍󷂀󴖸󶤎󷸎󶞰󾘍󴊿󴀖󵏖󴌽󳖛󴓟 19428-2959󱜃󶚏󳷾

󴓦

For referenced ASTM standards,visit the ASTM website,www.astm.org,or contact

ASTM Customer Service at www.astmorg/contact.For Annua Book of ASTM Standards

volume information,refer to the standard's Document Summary page on the ASTM website.

Current edition approved Jan.1,2025.Published January 2025.Originally approved in

2010.Last previous edition approved in 2016 as E2656-16.DOI: 10.1520/E2656-25.

!This practice is under the jurisdiction of ASTM Committee E55 on Manufac-ture of

Pharmaceutical and Biopharmaceutical Products and is the direct responsi-bility of

Subcommittee E55.12 on Process Applications.

2.2 󳡷󳗗󳫃󶜄󴲈󳗷󾘛

ICH Q2󾘉R2󾘊 󳤇󴺑󴲺󵏖󵶅󸆍󷋂󾘛󴲈󴸭󳔏󴲺󵏖󴉧 

ICH Q7󱜋󳪠󴲚󶩰󶥰󴁾󵰠󳖨󷃅󶨄󴨈󳩘󱜌

ICH Q8󾘉R2󾘊󱜋󶩰󳯂󴘁󳫒󱜌 ICH Q9

󾘉R1󾘊󱜋󷐩󷣐󷿏󷵪󶊢󵬇󱜌

ICH Q10 󶩰󳯂󷐩󷣐󳙔󶏼

ISO 15839 󵌵󷐩󰜕󰜕󵌵󳸩󶗀󳘡󴠠󳵩/󳤇󴺑󷊿󴀈󾘛󷃅󶨄󳮍󴜨󶟾

󵑌󷋖󰝵

JP 󶈭 2.59 󶇡 󴜼󴸊󴸻󵾴󵑌󴊛󰝶 󵈨󵐳󶩰󳡹 󶈭 2.2.44 󶇡 󶩰󵰩

󶖰󳨗󵌵󳔮󵶅󴜼󴸊󴸻󵾴󰝷

󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󾘉FDA󾘊󶈭 11 󷟩󳤇󴨈󳩘 󶽍󳔛

󴨈󳩘󾘛󶈭 11 󷟩󳤇 󵰶󴉑󷊱󴙖󾘜󵰶󴉑󶉿󳬎󰜕󰜕󶨄󳷵󳔏󴖕

󵰩 󰝸

󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󾘉FDA󾘊PAT 󴨈󳩘 󱜋󶽍󳔛󴨈󳩘󾘛

PAT󰜕󰜕󳤜󴲱󶩰󵥪󴘁󳫒󴽇󴺷󱜌

󵰠󳖨󳔏󷐩󷣐󳛞󷋂󰝸 󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󶩰󳯂󵰠󳖨󷐩

󷣐󶊢󵬇󷃅󶨄 󶩰󳯂󵰠󳖨󷐩󷣐󶊢󵬇󷃅󶨄

󷹣󳬒 21 󳔗󶖫󰜕󰜕󳻻󳖏󷿏󷵪󵶅󴲺󵏖󰝸 󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢

󵬇󴍁󶽍󳔛󴨈󳩘󾘛󳤇󴺑󶄌󴖐󳮍󴲺󵏖󸆍󷋂

󳨗󴉧󱜂󵰠󳖨󳮍󴪨󳤷󴲈󳗷󰝸 󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󴓦󶥻

󸆍󷋂󴨈󳩘 󶽍󳔛󴨈󳩘

󷋖󾘛󴓦󶥻󸆍󷋂󾘛󳔁󶤭󳪠󳤚󳮍󴊟󷓶󰝸 󱜋󶚏󳷾󶩰󳡹󱜌󶈭 643

󶇡 󴜼󴸊󴸻󵾴󾘉TOC󾘊󰝹 󱜋󶚏󳷾󶩰󳡹󱜌󶈭 1225 󶇡 󶩰󳡹󴲺

󵏖󸆍󷋂󰝹 󱜋󶚏󳷾󶩰󳡹󱜌󶈭 1226 󶇡 󶩰󳡹󴲺󵏖󵶅󵽯󷊥󰝹

󱜋󶚏󳷾󶩰󳡹󱜌󶈭 1231 󶇡 󶩰󵰩󶖰󳨗󵌵󰝹 󱜋󶚏󳷾󶩰󳡹󱜌󴨈

󳩘󶈭 1058 󶇡 󳤇󴺑󳗫󳵩󵽯󷊥󰝹

3.󴸰󷋮

3.1 󴸊󳡴󴸭󴼈󳣇󵥺󴊛󴸰󷋮󵶅󴊛󳕊󾘍󷋸󳫃󷴆󴊟󷓶󴼈󳣇 E2281󱜂

󴸰󷋮󴼈󳣇 E2363 󳮍󴨈󳩘 E2500 󳔮󵶅󴸰󷋮󷟩󳤇󱜃󴸊󳡴󴲺󵏖󸆍

󷋂󴸰󷋮󾘍󷋸󳫃󷴆 ICHQ2󾘉R2󾘊󱜃

4.󴊟󷓶󴜼󶗔

4.1 󴸭󴊟󷓶󳔻󵰩󴤸󴫑󳚜󳖇󳡆󳤇󵶅󴨈󴋽󾘍󳗦󴘁󳫒󳣻󳻻󳖏󶃒󴉧󳮍

󷿏󷵪󵶅󴛆󷂂󳛢󴝰󱜃

3Available from International Conference on Harmonisation of Technical Requirements for Registration

of Pharmaceuticals for Human Use(ICH),ICH Secretariat,c/o IFPMA,15 ch.Louis-Dunant,P.O.Box 195,1211

Geneva 20, Switzerland,http://www.ich.org.

4Available from International Organization for Standardization(ISO),1,ch.de la Voie-Creuse,Case postale

56,CH-1211,Geneva 20,Switzerland,http:// www.iso.ch.

5Available from Japanese Pharmacopoeia(JP),Standards Division,Office of Compliance and Standards,

Pharmaceuticals and Medical Devices Agency(PMDA), Shin-kasumigaseki Building,3-3-2,Kasumigaseki,

Chiyoda-ku,Tokyo 100-0013, Japan,http://www.std.pmda.go.jp.

󰝷Available from European Pharmacopoeia(Ph.Eur.),7 allee Kastner,CS 30026, F67081 Strasbourg,

France,http://www.pheur.org.

7Available from Food and Drug Administration (FDA),5600 Fishers Ln., Rockville,MD 20857,http://

www.fda.gov.

󳔻󴋺󳤷󶩰󵰩󵌵󵶅󴊟󴳷󳸩󶗀󴜼󴸊󴸻󵾴󾘉RTRT-OLTOC󾘊󴿁󵑌

󶏼󶗠󴊟󴲾󱜂󴨂󶗮󸆍󷋂󳮍󴨂󶗮󴰺󷛜󳝛󳣻󴴏󴵻󳢴󶉗󾘍󵽯󳛞󳡷󶈧

󳬉󳤷󶩰󵰩󵌵󴜼󴸊󴸻󵾴󾘉TOC󾘊󷃅󴼽󾘍󵥺󳤷󴊛󴸭󴨈󳩘󱜃󴸭󴨈

󳩘󳚞󴩯󴼈󳣇 E2281󱜂󴸰󷋮 E2363󱜂󴨈󳩘 E2500 󳗦󳫋 ICH Q2

󾘉R2󾘊󱜂ICH Q7󱜂ICH Q8󾘉R2󾘊󱜂ICH Q9󾘉R1󾘊 󳮍 ICH

Q10 󴨈󳩘󳤷󴊛󱜃󷂂󴊟󵪱󴸭󴊟󷓶󵶅󵷯󴼈󾘍󷸁󷝶󴚫󳗦󳔌󵉦󸆥󱜃

4.1.1 󴦁󴸰󷋅󳘱󰜕󰜕󷋅󳘱󴕷󳖇󷃤󵌵󶏼󶗠󱜂󴜼󴸊󴸻󵾴󾘉TOC󾘊

󵑌󷣐󴦁󴸰󳗦󳫋󵷹󳡴󵏖󷃅󷂂󵍃󱜃

4.1.2 󷿏󷵪󷋅󳘱󰜕󰜕󴋺󷾅󴸠󵶅󳢎󴀅󵬇󳷟󴰷󶏼󶗠󷊿󷊢󷛜󶽍󷐩

󷣐󷿏󷵪󳤇󴺑󾘍󳗦󵽯󴊛󶟾󳗤󶽩󳚀󵰩󵞺󵶅󳫗󴼸󳙎󶙯󱜃

4.1.3 󴱱󴩯󷐩󷣐󰜕󰜕󵽯󳛞󴹦󶣫󴜼󴸊󴸻󵾴󾘉TOC󾘊󵑌󷣐󶏼󶗠󵶅

󴱱󴩯󷐩󷣐󷜃󳬉󳸩󵌵󳷟󵰩󳷟󴰷󵑌󷋖󶏼󶗠󳔮󵶅󷾅󴸠󵰩󷜕󱜃󴂃󴺝

󴉙󳸩󵰩󳖏󳬒󴜼󴸊󴸻󵾴󴍟󴜨󴰿󵌵󵶅󵪱󴸊 TOC 󵑌󷣐󶏼󶗠󾘍󳤚󵽯

󳛞󳡷󴱱󴩯󵶅󶉊󴱉󴜨/󳔁󶣵󴜨󱜃

4.1.4 󴊟󴲾󶉗󵱦󰜕󰜕󳤷󴊛󵑂󶄌󳗦󵽯󳛞 RTRT 󴤑󳦠󴊟󴲾

4.1.5 󴨂󶗮󸆍󷋂󶄌󴖐󰜕󰜕󳤷󴊛󷐩󷣐󴪨󳤷󶉗󵱦󳗦󵽯󳛞󶏼󶗠󴜨󶟾

󵶅󳔁󶣵󴜨󱜃

4.1.6 󴨂󶗮󷛈󶄌󴰺󷛜󰜕󰜕󷋅󳘱󴕷󴊟󴲾󷛈󶄌󴰺󷛜󴪫󴲾󱜃

5.󷣎󷂂󴜨󳔏󵰩󷜕

5.1 󶩰󵰩󶖰󳨗󵌵󴴰󳤷󶩰󳮍󵰠󵥪󳤷󶩰󵰠󳖨󳔮󴸁󴔹󵰩󵶅󴤑󳤇󴤗

󳪠󴲚󱜃󵌵󵶅󶖰󴖧󴋺󳖏󴸁󶗉󶩰󳯂󵶅󷐩󷣐󶣴󳡴󷣎󷂂󱜃󴜼󴸊󴸻󵾴

󾘉TOC󾘊󵑔󴖧󴴰󶽢󷣐󷛚󶃎󵌵󶖰󴖧󵶅󳡴󷰯󴨈󴼈󳮍󴍟󴜨󾘍󳕠󴴰

󵷒󵑌󴱵󳔫󵌵󳣁󳨗󶏼󶗠󴜨󶟾󵶅󷣎󷂂󴥌󵊶󱜃TOC 󳤇󴺑󴴰󴋺󵌵󳔮

󴥁󴸊󳡲󳗸󶗔󳬉󵾴󵶅󵑌󷣐󾘍󳔎󳨆󴧭󳖍󵌨󳨗󵾴󾘉CO󰞃󾘊󱜂󵾴󷡹

󵌣󴼺󶂼󴉑󾘉HCO󰞄󰝼󾘊󴤗󵾴󷡹󴼺󶂼󴉑󾘉CO󰞄󰝼󾘊󴙣󴘐󵶅

󵾴󾘍󴕷󳗦󵋐󳩖󳙎󳙔󶃰󵶅󴸊󴸻󵾴󷐩󷣐󴹦󴦦󳭋󱜃

5.2 󷣈󵰩󴸭󷃅󶄌󳫰󴫑󳚜󵷹󳡴󳛢󴝰󾘍󳗦󳛀󴌲󶈧󳬉󳤷󶩰󶽍󳔛󴜼

󴸊󴸻󵾴󾘉TOC󾘊󵑔󴖧󷃅󴼽󵶅󵌵󵶅󴰿󶽍󳝛󳣻󴴏󴵻󳢴󶉗󱜃

6.󶄌󴖐

6.1 󴦁󴸰󷋅󳘱󾘛

6.1.1 󴱵󳙔󷽺󵷯󶨄󳷵󴖕󳔏󷒆󳣻󳤷󶩰󵰩󵌵󴜼󴸊󴸻󵾴󾘉TOC󾘊

󵑔󴖧󷃅󴼽󵶅󵷹󳡴󷿏󷵪󴤑󵋕󳚌󱜃󴖕󶪸󳫗󴋺󵌵󶏼󶗠󳔮 TOC 󵑔󴖧󱜂

󳸩󶗀 TOC 󵑌󷣐󶏼󶗠󴦁󴸰󴜨󶟾󳗦󳫋󳤷󶩰󵰩󵌵󶏼󶗠󷊿󷊢󵶅󵻦󷋇

󳮍󵬇󷃤󾘍󳗦󷵎󳙏󷿏󷵪󱜂󵽯󳛞󵉤󵽯󵶅󷐩󷣐󳢴󶉗󴕷󴊟󵪱󴦖󷑅󳷟

󴦦󴸁󴀨󳨗󾘉󱜋󶚏󳷾󶩰󳡹󱜌󶈭 1231 󶇡󳮍󾘉1-7󾘊󰝺󾘊󱜃TOC

󵑌󷣐󴦁󴸰󳸩󵑌󷋖󴲺󵏖 D4839󱜂D5904󱜂D5997 󳮍 D6317 󳗦

󳫋󴨈󳩘 D5173 󳔮󳹈󴸊󴫑󳫋󱜃

9The boldface numbers in parentheses refer to a list of references at the end of this standard.

8Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville, MD 20852-1790,http://

www.usp.org.

6.1.2 󴖕󷛜󶽍󴦁󴸰󷋅󳘱󾘍󳗦󷋅󳘱󴕷󴘁󳫒󳻻󳖏󷿏󷵪󳮍󶃒󴉧󵶅

RTRT-OLTOC 󶏼󶗠󷊿󷊢󱜃󴖕󳤪󵰩󵪱󴸊󴹦󵖑󵶅󵷹󳡴󳛢󴝰󴹦󵬇

󷃤󱜂󷃤󷣋󳮍󴊟󴲾󴦁󴸰󷋅󳘱󵶅󶗔󴺝󱜃󴸊󳡴 RTRT-OLTOC 󶏼

󶗠󷊿󷊢󵶅󳔁󶤭󳮍󳡸󳙔󶜄󶵒󳷡󶐡󱜂󴜨󶟾󵥺󴚂󳗦󳫋󸆍󷋂󵶅󳛢󴝰

󳫰󳸩󴓳󳫒󶽩󵶅󴲈󳗷󳮍󴲈󵨯󳔮󴥿󳤱󾘉8-15󾘊󱜃

6.1.3 󴋺󳖏󵪱󴸊󵶅󵌵󳣁󳨗󶏼󶗠󾘍󵰩󴤸󴖕󷋅󳘱󳪇󳫳󱜂󴙔󳥎󳮍󵙝

󳸩󵶅󴸊󴸻󵍢󴻔󵥪󴟆󳢶󱜃󴋺󵙝󳸩󴸊󴸻󵍢󴻔󵥪󵶅󷋅󳘱󴖕󳻻󳖏󴋺

󵌵󶏼󶗠󷊿󷊢󳮍󶗅󳗷󵶅󵪱󴊟󷋅󳘱󾘍󳗦󵽯󴊛󵥺󴊛󴤗󴖀󵏜󶨄󳷵󵶅

󴸊󴸻󵍢󴻔󵥪󷛜󳡦󵌵󳤇󷡎󶏼󶗠󵶅󳫰󶟾󴜨󱜃󵰩󴤸󴖕󳔏󴜼󴸊󴸻󵾴

󾘉TOC󾘊󳗫󳵩󳚜󴖕󳱇󳩐󳱇󾘍󳗦󵽯󴊛 TOC 󵑌󷣐󶏼󶗠󴴰󳬧󶟾󵗢

󷒴󷾅󴸠󴖕󵰩󵶅󷂂󵍃󾘍󳬍󴳷󶜄󶵒󳤱󳗼󳙖󴸊󴸻󵍢󴻔󵥪󷋅󳘱󵶅󶗔

󴺝󱜃

6.1.4 󴋺󳖏󴲱󵶅󵌵󳣁󳨗󶏼󶗠󾘍󳸩󷊿󷊢󱜂󵽯󷊥󳮍󸆍󷋂󵐼󳦩󴸠󷳵

󴖕󷃤󳢴󳤷󶩰󵰩󵌵󶏼󶗠󳔮󵙝󳸩󴸊󴊴󳨗󳬉󵥪󵶅󴉙󳸩󷳯󷾙󾘍󴕷󵷹

󴖕󷣈󳫗󶖡󵉤/󶘔󷃤/󷾅󷴳󴪫󴲾󱜃

6.1.5 TOC measurement system technology assessments shall

be achieved by meeting regulatory guidance requirements on

analytical procedure verifications and validations (ICH Q2(R2),

USP Chapter<1225>,and U.S.FDA Proce-dures and Methods

Validation).The requirements shall depend on the use of the

data and the intended use of the instrumen-tation.

6.1.5.1 󶚏󳷾󵏖󴚌󷂂󵍃󳫋󱜋󶚏󳷾󶩰󳡹󱜌󶈭<643>󶇡󵶅󸆍󷋂󰜕󰜕

󳚀󵰩󱜋󶚏󳷾󶩰󳡹󱜌󶈭<643>󶇡󴜼󴸊󴸻󵾴󾘉TOC󾘊󴿁󵑌󴲺󵏖󶈧

󳬉󶚏󳷾󵏖󴚌󴋺󳤷󶩰󵰩󵌵󳔮󴜼󴸊󴸻󵾴󴍟󴜨󴿁󵑌󵶅󷂂󵍃󱜃󱜋󶚏

󳷾󶩰󳡹󱜌󶈭<643>󶇡TOC󵶅󳚀󵰩󶜆󴳡󷸁󴋺󷋦󴲺󵏖󷛜󶽍󸆍󷋂󾘍

󳙇󴖕󵽯󷊥󳡷󳸩󴊟󷵆󳚀󵰩󴹢󳗷󳔌󷜃󵰩󱜃󳚀󵰩󶜆󴖕󳖇󷃤󾘍

󱜋󶚏󳷾󷿠󳯂󱜂󶩰󳯂󳮍󳨗󴂇󳯂󵏖󱜌󶈭501(b)󴹢󳗏󵏖󴚌󳔋󷊥󳫰

󱜋󶚏󳷾󶩰󳡹/󳷾󴊷󴀅󴲺󷷇󱜌󾘉USP/NF󾘊󳔮󵶅󳤇󴺑󶄌󴖐󾘍󳗦󵽯

󴊛󴴰󳬧󶈧󳬉󷋦󵏖󾘉󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󶄌󴖐󳮍󴲺󵏖󸆍

󷋂󾘊󱜃󶚏󳷾󶝕󷞧󵏖󷃅CFR 211.194(a)(2)󷃅󴊛󾘛󴛆󷽼󳸩󴊟󷵆󳚀

󵰩󴹢󳗷󳔌󸆍󷋂󶩰󳡹󳤇󴺑󴲺󵏖󵶅󷜃󵰩󴜨󱜃󳚀󵰩󶜆󴖕󷣈󵰩󱜋󶚏

󳷾󶩰󳡹󱜌󶈭<1226>󶇡󱜂ICH Q2󾘉R2󾘊󴤗󶉊󴱉󴲺󵏖󴹦󸆍󷋂󶩰

󳡹󶄌󴖐󱜃

6.1.5.2 󴜼󴸊󴸻󵾴󾘉TOC󾘊󳤇󴺑󴲺󵏖󵶅󸆍󷋂󳮍󵽯󷊥󶄌󴖐󴖕

󳚞󴩯 ICH Q2󾘉R2󾘊󱜂󱜋󶚏󳷾󶩰󳡹󱜌󶈭<1225>󶇡󴤗󶚏󳷾󷿠󳯂

󶩰󳯂󵷒󵹤󶊢󵬇󴍁󾘉FDA󾘊󵶅󶄌󴖐󳮍󴲺󵏖󸆍󷋂󷂂󵍃󱜃󵌵󳔮󵶅

TOC 󴍟󴜨󵑌󷣐󴖕󴙓󶍼󳔻󴹃󷐩󴿁󵑌󱜃󳸩󴹃󷐩󴿁󵑌󳔌󾘍󳫉󴸊󴊛

󷣐󴿁󵑌󳮍󷵑󴖧󴿁󵑌󳔥󶃎󳤇󶍼󱜃󴋺󳖏󵋐󶃎󳤇󶍼󾘍󷟾󴸊󴪩󶩑󵶅

󸆍󷋂󵑌󷋖󵔆󳩖󱜃󴥁󴸊󶩰󳡹󳔮󵶅 TOC 󴿁󵑌󴲺󵏖󳹈󳔻󷵑󴖧󴿁󵑌󱜃

󷵑󴖧󴿁󵑌󳗆󳖨󵰠󷜛󷛈󴤗󳔎󷜛󷛈󵶅󶗔󴺝󾘍󴂃󳷿 1 󴥁󶀻󱜃󳔻󳖇

󴪨󳤷󱜂󷒌󳧀󳤇󴺑󳮍󵷒󵑌󳸩󶗀󶏼󶗠󾘍󴕷󳚀󵰩󴊛󷣐󴱱󴩯󴊟󴳷󴰿

󶽍󵌵󾘍󳤇󴺑󴲺󵏖󷸁󷂂󳚀󵰩󴊛󷣐󴱱󴩯󾘍󳷡󵉥󳤇󴺑󴲺󵏖󴖕󴨊󵡨

󴊛󷣐󴿁󵑌󵶅󷂂󵍃󷛜󶽍󸆍󷋂󾘉󶚏󳷾 FDA PAT 󴨈󳩘󾘊󱜃󴊛󷣐󴱱

󴩯󵶅󳚀󵰩󴂃󳷿 2 󴥁󶀻󱜃󳤇󶍼󳮍󴪩󶩑󵑌󷋖󷃂󶽩 1󱜃󴷵󴀛󴸊󵰩󳛢

󴝰󳫰󳫃󶜄 ISO 15839󱜃

6.1.5.3 󶚏󳷾󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󾘉FDA󾘊󷊥󳔻󰜝󴊟󴳷󴰿

󶽍󴿁󵑌󳔏󴸀󳗤󳤇󴺑󶄌󴖐󵷹󴙔󰜞󾘍󴕷󳔕󶚏󳷾󵏖󷃅 CFR 211.165

󷃅󴊛󾘍󵰩󳖏󷛈󶄌󴪨󳤷󵷯󵶅󵶅󴸀󳗤󳤇󴺑󵑌󷋖󴲺󵏖󴤗󶄌󴖐󵶅󳣇

󵽯󴜨󱜂󵝶󴱐󴖧󱜂󵥺󴘃󴜨󳮍󷣎󵪱󴜨󴛆󷽼󶗐󷛈󸆍󷋂󴕷󷊱󴙖󳸩󴽉󱜃

6.2 󷿏󷵪󷋅󳘱󾘛

6.2.1 󶧦󴜼󴸊󴸻󵾴󾘉TOC󾘊󵑔󴖧󴱱󴩯󷂂󳗦󴊛󷣐󴲺󴘐󵰩󳖏󷒌󳧀

󳤇󴺑󱜂󷛈󶄌󴪨󳤷󴤗󴓦󶥻󵑂󶄌󳔮󾘍

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ASTM E2656-25 药用水总有机碳属性的实时释放测试(中文)

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