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Xarabass

Weet iemand welke testen er volgens USP gedaan moeten worden voordat water for injection parenteraal toegediend mag worden? en wat de eisen zijn voor wfi?

bvd

joepiedepoepie

wablief?

Raspoetin

Hierop zitten dezelfde eisen als sterile purified water. Even voor de goede orde: omdat je voor de USP moet betalen (en flink ook) zal deze info ook niet zomaar beschikbaar zijn voor iedereen. Ik wil je best op weg helpen, maar ik heb geen zin om chemieforum.nl in problemen te brengen door hier dingen te posten die niet mogen. Vandaar dat ik overal de volumes, concentraties, tijdsaanduidingen enz vervangen heb door een x, behalve de eisen. Aan de moderators de beslissing om dit te laten staan of niet.

Water for Injection packaged in bulk for commercial use elsewhere meets the requirement of the test for Bacterial endotoxins as indicated below and the requirements of all the tests under Sterile Purified Water, except Labeling.

Sterile Purified Water

Packaging and storageÃ¢"Preserve in suitable, tight containers.

LabelingÃ¢"Label it to indicate the method of preparation and that it is not for parenteral administration.

Steriliy: meet the requirements

pH : between 5.0 and 7.0 in a solution containing x mL of saturated potassium chloride solution per x mL of test specimen.

AmmoniaÃ¢"limit of 0.6 mg per L for containers having a fill volume of less than 50 mL and 0.3 mg per L where the fill volume is 50 mL or more.

CalciumÃ¢"To x mL add x mL of ammonium oxalate: no turbidity is produced.

Carbon dioxideÃ¢"To x mL add x mL of calcium hydroxide: the mixture remains clear.

ChlorideÃ¢"To x mL in a color-comparison tube add x drops of nitric acid and x mL of silver nitrate, and gently mix: any turbidity formed within x minutes is not greater than that produced in a similarly treated control consisting of x mL of a solution of sodium chloride in High-Purity Water, containing x µg of sodium chloride per L (x µg of Cl in x mL), viewed downward over a dark surface with light entering the tubes from the sides.

SulfateÃ¢"To x mL add x mL of barium chloride: no turbidity is produced.

Oxidizable substancesÃ¢"To x mL, add x mL of x N sulfuric acid, and heat to boiling. For Sterile Purified Water in containers having a fill volume of less than 50 mL, add x mL of x N potassium permanganate, and boil for x minutes; where the fill volume is 50 mL or more, add x mL of x N potassium permanganate, and boil for x minutes. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter: the pink color does not completely disappear.

Verder nog geleidbaarheid:

Code: Selecteer alles


Temp °C    Geleidbaarheid µS/cm

20                   1.1 

25                   1.3 

30                   1.4

En total organic carbon: <= 0.5 mg/l

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