| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets ACS Reagent Chemical Requirements |
| Meets N.F. Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| NF - Assay (H2SO4) (by acidimetry) |
95.0 - 98.0% |
| NF - Arsenic (As) |
<= 1 ppm |
| NF - Chloride (Cl) |
<= 0.005% |
| NF - Identification |
Passes Test |
| NF - Reducing Substances |
Passes Test |
| NF - Residue on Ignition |
<= 0.005% |
| Ammonium (NH4) |
<= 1 ppm |
| Appearance |
Passes Test |
| Assay (H2SO4) |
95.0 - 98.0% |
| Chloride (Cl) |
<= 0.1 ppm |
| Color (APHA) |
<= 10 |
| Heavy Metals (as Pb) |
<= 500.0 ppb |
| Nitrate (NO3) |
<= 0.5 ppm |
| Residue after Ignition |
<= 4 ppm |
| Specific Gravity at 60°/60°F |
>= 1.84 |
| Substances Reducing Permanganate (as SO2) |
<= 2 ppm |
| Trace Impurities - Aluminum (Al) |
<= 200.0 ppb |
| Trace Impurities - Arsenic (As) |
<= 0.004 ppm |
| Trace Impurities - Calcium (Ca) |
<= 200.0 ppb |
| Trace Impurities - Chromium (Cr) |
<= 100.0 ppb |
| Trace Impurities - Copper (Cu) |
<= 100.0 ppb |
| Trace Impurities - Gold (Au) |
<= 100.0 ppb |
| Trace Impurities - Iron (Fe) |
<= 200.0 ppb |
| Trace Impurities - Lead (Pb) |
<= 200.0 ppb |
| Trace Impurities - Magnesium (Mg) |
<= 200.0 ppb |
| Trace Impurities - Manganese (Mn) |
<= 100.0 ppb |
| Trace Impurities - Mercury (Hg) |
<= 5.0 ppb |
| Trace Impurities - Nickel (Ni) |
<= 200.0 ppb |
| Trace Impurities - Potassium (K) |
<= 300.0 ppb |
| Trace Impurities - Sodium (Na) |
<= 300 ppb |
| Trace Impurities - Tin (Sn) |
<= 200.0 ppb |
| Trace Impurities - Titanium (Ti) |
<= 200.0 ppb |
| Trace Impurities - Zinc (Zn) |
<= 200.0 ppb |
| |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Elemental Impurities (USP 232, EP 5.20) - Information on elemental impurities for this product is available on the associated Product Regulatory Data Sheet and elemental impurity profile report. |