สารบัญ

Contents
MENU

PURIFIED WATER, STERILE

Category Pharmaceutic aid (solvent).

Sterile Purified Water is Purified Water sterilized and suitably packaged. It contains no antimicrobial agents.

(Note It is used in the preparation of nonparenteral compendial dosage forms or in analytical applications requiring Purified Water where access to a validated Purified Water system is not practical. Do not use Sterile Purified Water in preparations intended for parenteral administration. For such purposes use Water for Injection, Bacteriostatic Water for Injection, or Sterile Water for Injection.)

Description Clear, colourless liquid; odourless.

Packaging and storage Sterile Purified Water shall be kept in suitable tightly closed containers.

Labelling The label on the container states (1) the method of preparation; (2) that it is not for parenteral administration.

Oxidizable substances To 100 ml, add 10 ml of 1 M sulfuric acid, and heat to boiling. For Sterile Purified Water in containers having a fill volume of less than 50 ml, add 0.40 ml of 0.020 M potassium permanganate, and boil for 5 minutes; where the fill volume is 50 ml or more, add 0.20 ml of 0.020 M potassium permanganate, and boil for 5 minutes. If a precipitate forms, cool in an ice-bath to room temperature, and pass through a sintered-glass filter: the pink colour does not completely disappear.

Water conductivity Complies with the “Water Conductivity” (For Sterile Water, Appendix 4.37).

Sterility Complies with the “Sterility Test” (Appendix 10.1).

 

MONOGRAPHS • PURIFIED WATER, STERILE
view 1,321 ผู้เข้าชม / View
หมายเหตุ / Note : TP II 2011 PAGE 143-144