Tartaric Acid (TA) spheres are hard, brittle, free flowing spherical masses prepared principally using Tartaric Acid 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 1% w/w|
|pH||Below 2 (2% aqueous dispersion)|
|Solubility||Soluble in water|
|Tartaric Acid (Assay)||Not less than 95%|
|Microbial Enumeration Test||Complies with pharmacopoeial requirements|
Protect from excessive temperature moisture and freezing.
Re-evaluation Date - 24 months from the date of manufacture.
These spheres can be used with modified release formulations of specific drug substances having low solubility but showing improved dissolution in acidic micro-environments, promoting consistency and uniformity of release profile thus ensuring a uniform therapeutic response.
#20 – #30 and #30 – #40
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