Sterile Water for Injection GMP high quality
1.Standard: BP
2.GMP & OEMAppearanceClear and colourless liquid.
Water for the preparation of medicines for parenteral administration when water is used as vehicle
(water for injections in bulk) and for dissolving or diluting substances or preparations for parenteral
administration (sterilised water for injections).
WATER FOR INJECTIONS IN BULK
PRODUCTIONWater for injections in bulk is obtained from water that complies with the regulations on water intended for
human consumption laid down by the competent authority or from purified water by distillation in an apparatus
of which the parts in contact with the water are of neutral glass, quartz or a suitable metal and which is fitted
with an effective device to prevent the entrainment of droplets. The correct maintenance of the apparatus is
essential. The first portion of the distillate obtained when the apparatus begins to function is discarded and the
distillate is collected.
In order to ensure the appropriate quality of the water, validated procedures and in-process-monitoring of the electrical conductivity and regular microbial monitoring are applied.
Water for injections in bulk is stored and distributed in conditions designed to prevent growth
of micro-organisms and to avoid any other contamination.
STERILISED WATER FOR INJECTIONSWater for injections in bulk that has been distributed into suitable containers, closed and sterilised by heat in
conditions which ensure that the product still complies with the test for bacterial endotoxins. Sterilised water
for injections is free from any added substances.
Examined in suitable conditions of visibility, it is clear and colourless.
Each container contains a sufficient quantity of water for injections to permit the nominal volume
to be withdrawn.
Storage:Keep the product in a cool and well-ventilated place
Keep out of the reach and sight of children.
Avoid direct sunlight
Packing & ShippingRegular packing:10ml/ampoule, 50ampoules/box, 20boxes/carton