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Is there any approved parental product (s.c. or i.m.) containing
Sucrose and/or PEG 3350 as additives? We have a lyophilized peptide
with these compounds added as bulking agents. We would like to know
the FDA's status on parental use of this two compounds. It will be
also helpful to know the European regulation about them.
Thanks for your help,
Delwar
Atrix Laboratories
Tel: (970) 482 5868
Fax: (970) 482 9735
2579 Midpoint Drive
Ft Collins, CO 80525
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Please check USP/NF
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Dalwar:
Handbook of injectable products should give you some idea. If you need any
assistance please call me, may be I can fax you needed information.
Prasad Tata
Mallinckrodt, Inc.
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