Back to the Top
The following message was posted to: PharmPK
Hi Chetan,
The acceptable limit for osmolality of the formulation is 250+/-50 mOsm.
Regards.
Pratima
[Plasma osmolality about 290 mOsm/Kg - ref Ansel & Stoklosa 12th
Also http://en.wikipedia.org/wiki/Plasma_osmolality - db]
Back to the Top
The following message was posted to: PharmPK
Dear Chetan,
You might not find any limit for osmolality for SC injection and like
parenteral it has to be as close as ~280-320 mosmoles, and can go
towards hyperosmolality (but not the other way round). Preferably should
be kept as close to "nice to have' limits and not beyond 1000 mosmoles
or similar. It will be prudent to have a vehicle tolerabiltiy before
starting the study in these cases as rodent species differ in their
sensitivities to the pH of the vehicle at times.
Hope it helps.
regards
Vaibhav Sihorkar
Head, Pharmaceutical Development
Aurigene Discovery Technologies Ltd.,
Bollaram Road, Miyapur,
Hyderabad - 500049. A.P., India
|
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@lists.ucdenver.edu with "Osmolality limits for sc injection in mice" as the subject |
Copyright 1995-2014 David W. A. Bourne (david@boomer.org)