Karl Fisher/lyophilization

Gvran Karlsson (101634.415@compuserve.com)
Tue, 14 Jul 1998 01:46:36 -0400

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Hi,
I have learned this week from this forum that lyophilized proteins may
contain about 20 % (weight) of bound water. Does a Karl Fisher analysis
detect
all this bound water (using eg 50 % methanol/ 50% formamide)?
The USP/Ph.Eur. often states that lyophilized pharmaceutical proteins
should not exceed 3 % in water content.

Best regards,
Goran Karlsson
Pharmacia & Upjohn
Plasma Products R&D
Analytical Chemistry
Stockholm

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