필트로스코리아

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정제수 품질 기준

몇몇 조직에서는 사용하는 용도에 따라 정제수의 품질 표준을 설정했습니다.

그중에는 다음이 포함됩니다.

ASTM (American Society for Testing and Materials)
NCCLS (National Committee for Clinical Laboratory Standards)
ISO International Organization for Standarization
EP y USP (Pharmacopea Europea y Pharmacopea Americana)

(ASTM) D1193-91American Society for Testing and Materials
Standard Specification for Reagent Water

Parameter
Type Ⅰ Type Ⅱ Type Ⅲ Type Ⅳ
Electrical Conductivity Max. (µS/cm @ 25ºC)
0.056 1.0 4.0 5.0
Electrical Resistivity (MΩ-cm @ 25ºC)
18.2 1.0 0.25 0.2
pH at 25ºC
- - - 0.5 - 8.0
TOC máx. (µg/L)
10 50 200 N/A
Sodium máx. (µg/L)
1 5 10 50
Total Silica max. (µg/L)
3 3 500 N/A
Chlorides max. (µg/L)
1
5 10 50
Endotoxins IU/ml
< 0.03
< 0.25 - -

National Committee for Clinical Laboratory Standards (NCCLS)

Parameter
Type Ⅰ Type Ⅱ Type Ⅲ
Bacteria (CFU/ml)
< 10 < 1,000 NA
pH
NA NA 5.0 - 8.0
Resistivity (MΩ.cm @ 25ºC)
> 10* > 1 > 0.1
SIlica (mg/L)
< 0.05 < 0.1 < 1
Total Solids (mg/L)
0.1 1 5
Total Oxidisable Organic Carbon (mg/L)
< 0.05 < 0.2 < 1
Particulate matter
< 0.2㎛

* Type I resistivity is measured in line

ISO International Organization for Standardization. ISO 3696.
Water for analytical laboratory use - Specification and test methods

Parameter
Degree 1 Degree 2 Degree 3
pH at 25ºC
N/A N/A 5.0 a 7.5
Electrical conductivity (µS/cm 25ºC, máx).
0.1 1.0 5.0
Oxidizable matter. Oxigen (O) (content mg/L. máx)
N/A 0.08 0.4
Absorbance at 254 nm and 1 cm optical path lenght. Absorbance units, máx.
0.001 0.01 Not Specified
Residue after evaporation at 110ºC mg/kg, máx
N/A 1 2
Silica content (SiO2) (mg/L., máx )
0.01 0.02 Not Specified

Pharmacopoeia
Some Pharmacopoeias have set requirements for water. Among the best known are the USP (United States Pharmacopoeia.) and EP (European Pharmacopoeia). Pharmacopoeias also establish purity criteria (microbiological and pyrogen content) for sterile water and water for injection.

Parameter
Type Ⅰ Type Ⅱ
Nitrates
< 0.2 ppm
-
Heavy Metals
< 0.1 ppm
-
TOC
< 500 µg/L C
< 500 µg/L C
Conductivity
< 1.1 µS/cm a 20ºC
< 1.3 µS/cm a 25ºC
Bacteria
< 100 CFU/ml
< 100 CFU/ml

Parameter	Type Ⅰ	Type Ⅱ	Type Ⅲ	Type Ⅳ
Electrical Conductivity Max. (µS/cm @ 25ºC)	0.056	1.0	4.0	5.0
Electrical Resistivity (MΩ-cm @ 25ºC)	18.2	1.0	0.25	0.2
pH at 25ºC	-	-	-	0.5 - 8.0
TOC máx. (µg/L)	10	50	200	N/A
Sodium máx. (µg/L)	1	5	10	50
Total Silica max. (µg/L)	3	3	500	N/A
Chlorides max. (µg/L)	1	5	10	50
Endotoxins IU/ml	< 0.03	< 0.25	-	-

Parameter	Degree 1	Degree 2	Degree 3
pH at 25ºC	N/A	N/A	5.0 a 7.5
Electrical conductivity (µS/cm 25ºC, máx).	0.1	1.0	5.0
Oxidizable matter. Oxigen (O) (content mg/L. máx)	N/A	0.08	0.4
Absorbance at 254 nm and 1 cm optical path lenght. Absorbance units, máx.	0.001	0.01	Not Specified
Residue after evaporation at 110ºC mg/kg, máx	N/A	1	2
Silica content (SiO2) (mg/L., máx )	0.01	0.02	Not Specified

(ASTM) D1193-91American Society for Testing and MaterialsStandard Specification for Reagent Water

National Committee for Clinical Laboratory Standards (NCCLS)

ParameterType ⅠType ⅡType ⅢBacteria (CFU/ml)< 10< 1,000NApHNANA5.0 - 8.0Resistivity (MΩ.cm @ 25ºC) > 10* > 1 > 0.1SIlica (mg/L)< 0.05< 0.1< 1Total Solids (mg/L)0.115Total Oxidisable Organic Carbon (mg/L)< 0.05< 0.2< 1Particulate matter< 0.2㎛* Type I resistivity is measured in line

ISO International Organization for Standardization. ISO 3696.Water for analytical laboratory use - Specification and test methods

Pharmacopoeia Some Pharmacopoeias have set requirements for water. Among the best known are the USP (United States Pharmacopoeia.) and EP (European Pharmacopoeia). Pharmacopoeias also establish purity criteria (microbiological and pyrogen content) for sterile water and water for injection.

ParameterType ⅠType ⅡNitrates< 0.2 ppm-Heavy Metals< 0.1 ppm-TOC< 500 µg/L C< 500 µg/L CConductivity< 1.1 µS/cm a 20ºC< 1.3 µS/cm a 25ºCBacteria< 100 CFU/ml< 100 CFU/ml

(ASTM) D1193-91American Society for Testing and Materials
Standard Specification for Reagent Water

ISO International Organization for Standardization. ISO 3696.
Water for analytical laboratory use - Specification and test methods

Pharmacopoeia
Some Pharmacopoeias have set requirements for water. Among the best known are the USP (United States Pharmacopoeia.) and EP (European Pharmacopoeia). Pharmacopoeias also establish purity criteria (microbiological and pyrogen content) for sterile water and water for injection.

Parameter
Type Ⅰ Type Ⅱ
Nitrates
< 0.2 ppm
-
Heavy Metals
< 0.1 ppm
-
TOC
< 500 µg/L C
< 500 µg/L C
Conductivity
< 1.1 µS/cm a 20ºC
< 1.3 µS/cm a 25ºC
Bacteria
< 100 CFU/ml
< 100 CFU/ml