Colloidal Silicon Dioxide (SiO2) spheres are hard free flowing spherical masses prepared principally using Colloidal Silicon Dioxide plus some minor common excipients required for making spheres.
The ingredients used have GRAS status and are compliant with monographs of all the recognized pharmacopoeias.
|Appearance||White hard free flowing spherical pellets|
|Loss on Drying||Not more than 10% w/w|
|pH||5 to 7.5 (2% aqueous dispersion)|
|Solubility||Insoluble in water|
|Microbial Enumeration Test||Complies with pharmacopoeial requirements|
Protect from excessive temperature moisture and freezing.
Re-evaluation Date - 36 months from the date of manufacture.
These spheres can be used as an inert base for modified release formulations promoting consistency and uniformity of release profile thus ensuring a uniform therapeutic response.
#30 – #40 and #40 - #60
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