Long-term stabilized formulations

Details Long-term stabilized formulations Long-term stabilized formulations

2005-06-21

2005-06-21

Kemmerer, Elizabeth C. (Department: 1646)

Drug, bio-affecting and body treating compositions

Lymphokine

C530S351000, C514S002600

Reexamination Certificate

active

06908610

ABSTRACT:
A stable G-CSF formulation having a residual ratio of G-CSF of 90% or more after long-term storage testing at 25° C. for 3 months or a residual ratio of G-CSF of 90% or more after long-term storage testing at 40° C. for 2 months or a residual ratio of G-CSF of 90% or more after accelerated testing at 50° C. for 1 month or a residual ratio of G-CSF of 90% or more after accelerated testing at 60° C. for 2 weeks and a content of Met-oxidized G-CSF of 1% or less after accelerated testing at 50° C. for 1 month or after accelerated testing at 60° C. for 2 weeks.

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