| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets J.P. Chemical Specifications |
| Meets N.F. Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| NF - Assay (as as Mg) (dried basis) |
4.0 - 5.0% |
| NF - Stearic Acid |
>= 40.0% |
| NF - Stearic and Palmitic Acids |
>= 90.0% |
| NF - Identification A |
Passes Test |
| NF - Identification B |
Passes Test |
| NF - Acidity or Alkalinity |
Passes Test |
| NF - Microbiological |
Passes Test |
| NF - Total Aerobic Microbial Count (cfu/g) |
<= 1000 |
| NF - Total Mold and Yeast Count |
<= 100 cfu/g |
| NF - Salmonella Species (negative) |
Passes Test |
| NF - Escherichia Coli (negative) |
Passes Test |
| NF - Loss on Drying at 105°C |
<= 4.0% |
| Specific Surface Area, m²/g |
6.0 - 12.0 |
| NF - Limit of Chloride |
<= 0.025% |
| NF - Limit of Sulfate |
<= 0.5% |
| NF - Cadmium (Cd) |
<= 3 ppm |
| NF - Lead (Pb) |
<= 10 ppm |
| NF - Nickel (Ni) |
<= 5 ppm |
| EP/BP - Identification C (Major Peak) |
Passes Test |
| EP/BP - Identification B (Acid Value) |
195 - 210 |
| EP/BP - Identification D (Magnesium) |
Passes Test |
| EP/BP - Acidity or Alkalinity |
Passes Test |
| Chloride (Cl) |
<= 0.025% |
| EP/BP - Sulfate (SO4) |
<= 0.5% |
| EP/BP - Cadmium (Cd) |
<= 3 ppm |
| EP/BP - Lead (Pb) |
<= 10 ppm |
| EP/BP - Nickel (Ni) |
<= 5 ppm |
| EP/BP - Loss on Drying at 105°C |
<= 4.0% |
| Escherichia Coli (negative) |
Passes Test |
| EP/BP - Assay (as as Mg) (dried basis) |
4.0 - 5.0% |
| Salmonella (absent) |
Passes Test |
| EP/BP - Stearic Acid |
>= 40.0% |
| EP/BP - Stearic and Palmitic Acids |
>= 90.0% |
| Total Aerobic Microbial Count (cfu/g) |
<= 1000 |
| Total Mold and Yeast Count (cfu/g) |
<= 100 |
| JP - Identification |
Passes Test |
| JP - Acidity or Alkalinity |
Passes Test |
| JP - Chloride (Cl) |
<= 0.025% |
| JP - Sulfate (SO4) |
<= 0.5% |
| JP - Heavy Metals (as Pb) |
<= 20 ppm |
| JP - Stearic Acid |
>= 40.0% |
| JP - Stearic and Palmitic Acids |
>= 90.0% |
| JP - Loss on Drying at 105°C |
<= 4.0% |
| JP - Microbiological |
Passes Test |
| JP - Total Aerobic Microbial Count (cfu/g) |
<= 1000 |
| JP - Total Mold and Yeast Count |
<= 100 cfu/g |
| JP - Salmonella Species (negative) |
Passes Test |
| JP - Escherichia Coli (negative) |
Passes Test |
| JP - Assay (as as Mg) (dried basis) |
4.0 - 5.0% |
| Appearance (Fine white powder) |
Passes Test |
| Particle Size 90th Percentile |
<= 35µm |
| Particle Size 50th Percentile |
6.0 - 14.0µm |
| Sieve Test US Standard No. 325 - % Thru |
>= 99.5% |
| Apparent Density |
0.07 - 0.17 g/cm3 |
| Tapped Density |
0.18 - 0.33 g/cm3 |
| |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Fatty acids are derived from edible sources. |