| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets J.P. Chemical Specifications |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| USP- Identification A |
Passes Test |
| USP- Identification B |
Passes Test |
| USP- Acidity or Alkalinity |
Passes Test |
| USP- Appearance of Solution |
Passes Test |
| USP- Aluminum (Al) |
<= 0.2 ppm |
| USP- Arsenic (As) |
<= 1 ppm |
| USP- Barium (Ba) |
Passes Test |
| USP- Bromide (Br) |
<= 100 ppm |
| USP- Ferrocyanide |
Passes Test |
| USP- Iodides (I) |
Passes Test |
| USP- Iron (Fe) |
<= 2 ppm |
| USP- Loss on Drying at 105°C |
<= 0.5% |
| USP- Magnesium and Alkaline Earth Metals (as Ca) |
<= 100 ppm |
| USP- Nitrite (NO2) (Absorbance Value) |
<= 0.01 |
| USP- Phosphate (PO4) |
<= 25 ppm |
| USP- Potassium (K) |
<= 500 ppm |
| USP- Sulfate (SO4) |
<= 200 ppm |
| USP- Assay (NaCl) (dried basis) |
99.0 - 100.5% |
| EP/BP- Identification A |
Passes Test |
| EP/BP- Identification B |
Passes Test |
| EP/BP- Aluminum (Al) |
<= 0.2 ppm |
| EP/BP- Appearance of Solution |
Passes Test |
| EP/BP- Acidity or Alkalinity |
Passes Test |
| EP/BP- Bromide (Br) |
<= 100 ppm |
| EP/BP- Ferrocyanide |
Passes Test |
| EP/BP- Iodide (I) |
Passes Test |
| EP/BP- Nitrite (NO2) |
<= 0.01 |
| EP/BP- Phosphate (PO4) |
<= 25 ppm |
| EP/BP- Sulfate (SO4) |
<= 200 ppm |
| EP/BP- Arsenic (As) |
<= 1 ppm |
| EP/BP- Barium (Ba) |
Passes Test |
| EP/BP- Iron (Fe) |
<= 2 ppm |
| EP/BP- Magnesium and Alkaline Earth Metals |
<= 100 ppm |
| EP/BP- Loss on Drying at 105°C |
<= 0.5% |
| EP/BP- Potassium (K) |
<= 500 ppm |
| EP/BP- Assay (NaCl) (dried basis) |
99.0 - 100.5% |
| EP/BP- Endotoxin Concentration, IU/g |
<= 2.5 |
| JP- Assay (NaCl) (dried basis) |
99.0 - 100.5% |
| JP- Identification A |
Passes Test |
| JP- Identification B |
Passes Test |
| JP- Acidity or Alkalinity |
Passes Test |
| JP- Clarity and Color of Solution |
Passes Test |
| JP- Bromide (Br) |
Passes Test |
| JP- Ferrocyanide |
Passes Test |
| JP- Iodide (I) |
Passes Test |
| JP- Iron (Fe) |
Passes Test |
| JP- Magnesium and Alkaline Earth Metals |
Passes Test |
| JP- Phosphate (PO4) |
Passes Test |
| JP- Sulfates (SO4) |
Passes Test |
| JP- Heavy Metals (as Pb) |
<= 3 ppm |
| JP- Barium (Ba) |
Passes Test |
| JP- Arsenic (As) |
<= 2 ppm |
| JP- Loss on Drying |
<= 0.5% |
| Total Aerobic Microbial Count, For Information Only |
| Total Yeasts and Molds Count, For Information Only |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Must be subjected to further processing during the preparation of injectable dosage forms |
| |
| 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. |