Additives to biological substances. V--The stability of lactose as a carrier for Biological Standards.
The stability of freeze-dried lactose has been studied, by accelerated degradation, after being ampouled under the conditions employed for the preparation of International Standards and Reference Preparations and also under less stringent conditions which might facilitate degradation. The possible formation of the reactive product, 5-hydroxymethyl-furfural, has been monitored over a period of 10 years at temperatures up to 56 degrees C. No evidence has been obtained to suggest that the formation of this compound would present a hazard to the stability of standards prepared by the procedures customarily employed.
Calam
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DH
Division of Chemistry, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, UK.
Tarelli
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E
D004355:Drug Stability; D005079:Excipients / Q000592:standards*; D005612:Freeze Drying; D005662:Furaldehyde / Q000031:analogs & derivatives / Q000032:analysis; D007785:Lactose / Q000592:standards*; D012015:Reference Standards
D005079:Excipients; C008046:5-hydroxymethylfurfural; D005662:Furaldehyde; D007785:Lactose