Stability test. Both before and after heating the final liquid product or reconstituted dried product at 37° C. for 7 days there should be no visible evidence of precipitation or turbidity. Moreover, after heating at 57° C. for 4 hours there should be no visible evidence of gelation. Loss of weight on drying – When dried over phosphorus pentoxide at a pressure not exceeding 0.02 mm. of mercury for 24 hours it must not lose more than 0.5 per cent of its weight. Storage – The dried human gamma globulin must be kept in an atmosphere of nitrogen or in a vacuum in a sterile container sealed so as to exclude micro-organisms and, as far as possible, moisture, protected from light and stored at a temperature below 20° C. Labelling – The label on the container shall state
Appears in 2 contracts
Sources: European Agreement on the Exchange of Therapeutic Substances of Human Origin, European Agreement on the Exchange of Therapeutic Substances of Human Origin