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ჩڵ䃢Ꮧ


fⅤ͝⮴ᱲ䉘ࣺ㶑䛿ᴷ۶

fᱲ䉘ᄩ჎侼⮴ᒡ৽

f㏟Ⅴభ䭵ᴷ۶

f㏟ࡆឰᱟപᱜ࣏⤶

Ⅴ⮴ᵨᓳ⤶ᔥ⩘ژf჎侼ეႹ

न়ϗৱϻ㏽ڜf


ÉVÉNEMENT-date1


Ⅴ͝⮴ᱲ䉘ࣺ㶑䛿ᴷ۶


ÉVÉNEMENT-date2


1
ࠍ㔃
㫨ਁ

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⎧⌻
ൠл≤
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Ⅴ͝ᱲ䉘⏦㼓⮴ᬐᱪ➙⏦㼓⮴᰹
ᱪ➙
+-COOH

܍㘦⏦㼓⅄
+
+++CO,O
---+---+22
+--++--+
+---+---
++++

ᗜ⊞䷇㇂ࣺᓞ⩏➙


㉐ℂڵ


ÉVÉNEMENT-date4


2
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fᬐᱪ➙
f᰹ᱪ➙
f䷇㇂
f㘦҃
ℂ㉐喊ڵf⩏➙ᕗᱲ䉘喉
f⏦㼓⅄


ÉVÉNEMENT-date5


ᴃ➙⮴ᠷᴷ↑ڣⅤ͝᰹㏟


f⩥ᄬ⢷(us/cm)
f⩥䭫⢷(Mohm-cm)
f䛽䜁ᆎ(ppb)
fTOC(ppb)
f㏶㣼(CFU/ml)
f☝⏀(EU/ml)
ℂ㉐喍ᵨ䚨䚦喊ڵ喉
f䷇㇂


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3
Ⅴభ䭵ᴷ۶㏟


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భ䭵፨⩘ᴷ۶


f*BritishStandardsInstitute(BSI)

f*AmericanSocietyforTestingandMaterials(ASTM)

f*InternationalOrganisationforStandardisation(ISO)

f*NationalCommitteeforClinicalLaboratoryStandards(CLSI)

f*USPharmacopoeia(USP)

f*BritishandEuropeanPharmacopoeia(BP&EP)


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4
Ⅴభ䭵ᴷ۶㏟


AmericanSocietyfortestingandMaterials
(ASTM)D1193-91

ParameterType1*Type2**Type3***Type4

Electricalconductivity0.05610.255
ElectricalResistivity18140.2
pHN/AN/AN/A5.0-8.0
TOCmaxmicrogramsperlitre10050200nolimit
Sodiummaxmicrogramsperlitre151050
Silicamaxmicrogramsperlitre33500nolimit
Chloridemaxmicrogramsperlitre151050

*requirestheuseof0.2micronfiltration
**preparedbydistillation
***requirestheuseofa0.45filter

TypeATypeBTypeC
Totalheterotrophicbacterialcount10/1000ml10/100ml100/10ml
EndotoxinmaxEU/ml0.030.25N/A


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NCCL喉CLSI)ᴷ۶


CAP჎侼ე⩘Ⅴ㺱ⅲ喛

CLRW

Maximummicrobialcontent(CFU/mL)10
Minimumresistivity(megohm-cm)10(in-line)


Particulatematter0.22umfilter

CLSI჎侼ე⩘Ⅴ㺱ⅲ喛
NationalCommitteeforClinicallaboratoryStandards(NCCLS)

ParameterTypeITypeIITypeIII

BacteriaCFU/ml<10<1000N/A
pHN/AN/A5.0-8.0
Resistivity>10*>1>0.1
Silica<0.05<0.1<1
TotalSolids0.115
TotalOxidisableOrganicCarbon<0.05<0.2<1


TypeImustbefreeofparticulate>0.2micron
*ResistivtyofType1mustbemeasuredin-line

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5
Ⅴభ䭵ᴷ۶㏟


USP,EP,BP&JP
PharmacopeiaCompaisons
WaterforInjection

ParameterUSP24EP2000BP1999JPXIII

Electricalconductivity<1.3uS/cm<1.1us/cm~~
Nitrates~<0.2ppm<0.2ppmtest
Nitrites~~~test
pH~~