Page 176 - Pharmaceutics IV (02-06-01305)
P. 176
-Blood older than21 days is not normally considered
suitable suitable for transfusion. The plasma proteins are
more stable .Because of instability in solution some protein-
containing products are issued as a freeze-dried powder
,sealed in presence of dry nitrogen . Such preparations are
hygroscopic and may become unstable or insoluble if
moisture gains access.e.g. through a loose or faulty seal.
bottles.Double or triple packs are convenient for preparing
BP requirement : sterility ,identiy ,freedom from pyrogen,
total protein content,electrolyte content,the presence of
preservatives and stabilizers& in the case of freeze-dried
preparations, solubility and residual moisture content. and
define required protein composition ,as determined by
electrophoretic analysis
The label must include .: 1-correct name of the product.
2-An identifying batch number.
3-Information concerning potency or conc.
4-Name & address of the manufacturer or authorized
distributer.
5-Date of manufacturer
-5-