Purified Water

Highly Purified Water

Water For Injection

USP Process Distillation, reverse osmosis and any other suitable process

EP Distillation, ion exchange, reverse osmosis and any other suitable process

USP N/A

EP Double-pass reverse osmosis coupled with other suitable techniques such as ultrafiltration and deionisation, for example 1,1 S/cm @ 20C <10 cfu/ 100 ml < 0,25 IU/ml

USP Distillation or reverse osmosis

EP Distillation

Conductivity Bacteria Endotoxin

1,3 S/cm @25C 100 cfu/ml (suggested) N/A

< 4,3 S/cm @ 20C < 100 cfu/ml < 0,25 IU/ml (only for bulk water for dialysis) 0,5 mg/l 5-7 0,2 ppm 0,1 ppm 10 ppb ( if intended for use in the manufacture of dialysis solutions )

N/A N/A N/A

1,3 S/cm @ 25C < 10 cfu/ 100 ml (suggested) < 0,25 IU/ml

1,1 S/cm @ 20C < 10 cfu/ 100 ml < 0,25 IU/ml

TOC pH Nitrates Heavy metals Aluminium

500 ppb 5-7 N/A N/A N/A

N/A N/A N/A N/A N/A

0,5 mg/l 5-7 0,2 ppm 0,1 ppm 10 ppb ( if intended for use in the manufacture of dialysis solutions )

500 ppb 5-7 N/A N/A N/A

0,5 mg/l 5-7 0,2 ppm 0,1 ppm 10 ppb (if intended for use in the manufacture of dialysis solutions)