| GMP Manufactured Product |
| Meets N.F. Requirements |
Assay （as as Mg）
（dried basis） | 4.0 - 5.0 % |
| Stearic Acid | min. 40.0 % |
| Stearic and Palmitic Acids | min. 90.0 % |
| Identification A | Passes Test |
| Identification B | Passes Test |
| Acidity or Alkalinity | Passes Test |
| Microbiological | Passes Test |
| Total Aerobic Microbial Count （cfu/g） | max. 1000 |
| Total Mold and Yeast Count （cfu/g） | max. 500 |
| Salmonella Species （negative） | Passes Test |
| Escherichia Coli （negative） | Passes Test |
| Loss on Drying at 105°C | max. 6.0 % |
| Specific Surface Area, m2/g | 6.0 - 12.0 |
| Limit of Chloride | max. 0.025 % |
| Limit of Sulfate | max. 0.5 % |
| Lead （Pb） | max. 10 ppm |
| |
| Meets BP/Ph.Eur. Chemical Specifications |
| Identification C | Passes Test |
| Identification D | Passes Test |
| Acidity or Alkalinity | Passes Test |
| Chloride （Cl） | max. 0.025 % |
| Sulfate （SO4） | max. 0.5 % |
| Cadmium （Cd） | max. 3.0 ppm |
| Lead （Pb） | max. 10.0 ppm |
| Nickel （Ni） | max. 5.0 ppm |
| Loss on Drying at 105°C | max. 6.0 % |
| Escherichia Coli （negative） | Passes Test |
Assay （as as Mg）
（dried basis） | 4.0 - 5.0 % |
| Salmonella （absent） | Passes Test |
| Stearic Acid | min. 40.0 % |
| Stearic and Palmitic Acids | min. 90.0 % |
| Total Aerobic Microbial Count （cfu/g） | max. 1000 |
| Total Mold and Yeast Count （cfu/g） | max. 100 |
| |
| Meets JP Chemical Specifications |
| Identification A | Passes Test |
| Identification B | Passes Test |
| Acidity or Alkalinity | Passes Test |
| Chloride （Cl） | max. 0.025 % |
| Sulfate （SO4） | max. 0.5 % |
| Heavy Metals （as Pb） | max. 20 ppm |
| Stearic Acid | min. 40.0 % |
| Stearic and Palmitic Acids | min. 90.0 % |
| Loss on Drying at 105°C | max. 6.0 % |
| Microbiological | Passes Test |
| Total Aerobic Microbial Count （cfu/g） | max. 1000 |
| Total Mold and Yeast Count （cfu/g） | max. 500 |
| Salmonella Species （negative） | Passes Test |
| Escherichia Coli （negative） | Passes Test |
Assay （as as Mg）
（dried basis） | 4.0 - 5.0 % |
| |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Bulk Pharmaceutical Chemical |
| CAUTION: For manufacturing, processing or repacking. |
| For a certificate of lot analysis, visit www.mallchem.com or call1-. |
