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The Gravimetric Method for the Determination of Residual Moisture in Freeze-Dried Biological Products

The Gravimetric Method for the Determination of Residual Moisture in Freeze-Dried Biological Products

J C May, R M Wheeler, E Grim

Cryobiology. 1989 Jun;26(3):277-84.

PMID: 2743789

Abstract:

The gravimetric test for the determination of residual moisture in freeze-dried biological products performed in a humidity- and temperature-controlled room with the use of scrupulous gravimetric analytical technique can be used to accurately determine residual moisture in freeze-dried biological products such as antihemophilic factor (human) or honey bee venom allergenic extract. This method determines the first water of hydration of sodium tartrate dihydrate (7.93%) to within 1.3% of the calculated value with a relative standard deviation of 0.3% for 10 replicates. For this gravimetric procedure, freeze-dried samples containing from 1.12 to 4.4% residual moisture had relative standard deviations ranging from 3.6 to 9.1%. Samples containing less than 1.0% residual moisture by the gravimetric method such as intravenous immune globulin and antihemophilic factor (human) had relative standard deviations ranging from 16.7 to 47.0%. Relative standard deviations for residual moisture tests performed on comparable samples by the Karl Fischer and thermogravimetric methods showed similar variability.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP6106247-A	Sodium tartrate dihydrate		6106-24-7	Price

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