GALENIC
FORMULATIONS OF (±)
IQB-9302 HYDROCLHORIDE
A) FORMULATIONS FOR USE IN ANIMAL
STUDIES
The following dose solutions were
prepared using purified water, and the osmolality was measured using a
calibrated osmometer.
IQB-9302.HCl Solution |
Osmolality |
1 mg/ml (0.0101 g/10 ml)
2 mg/ml (0.0201 g/10 ml)
3 mg/ml (0.0301 g/10 ml) |
3 mOsm
11 mOsm
16 mOsm |
Purified Water =
0 mOsm
Physiological Saline (0.9% NaCl)
= 279 mOsm
The following dose solutions were
prepared using physiological saline (0.9% Sodium Chloride) and osmolality
was again measured using a calibrated osmometer.
iQB-9302.HCl Solution |
Osmolality |
1 mg/ml (0.0101 g/10 ml)
2 mg/ml (0.0201 g/10 ml)
3 mg/ml (0.0301 g/10 ml) |
285 mOsm
290 mOsm
297 mOsm |
Normal serum osmolality is between
285 and 310 mOsm. Reference: Clinical Diagnosis and
Management, 17th edition, Page #122.
Test article was weighed on a calibrated,
electronic, top-loading balance accurate to within ± 0.1 mg.
An additional 0.1 mg was added to each solution to be assured that the
solution contained at least the amount indicated.
On the basis of these data, doses
for acute and subacute studies in animals were prepared in normal physiological
saline
|