| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| USP - Acid-Soluble Substances |
<= 3.5 % |
| USP - Adsorptive power |
Passes Test |
| USP - Chloride (Cl) |
<= 0.2 % |
| USP - Cyanogen Compounds |
Passes Test |
| USP - Loss on Drying |
<= 15.0 % |
| USP - Microbial Limit |
Passes Test |
| USP - Reaction |
Passes Test |
| USP - Residue on Ignition |
<= 4.0 % |
| USP - Sulfate (SO₄) |
<= 0.2 % |
| USP - Sulfide (S) |
Passes Test |
| USP - Uncarbonized Constituents |
Passes Test |
| Metallic Residues: No metal catalysts or metal reagents, as defined by |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of |
| this material. |
