Magnesium Stearate NF 12Kg BP FCC
2257/88-12Kg
Non Hazardous
Product code 2257
| Food GMP Manufactured Product | |
| Meets N.F. Requirements | |
| Meets E.P. Chemical Specifications | |
| Meets J.P. Chemical Specifications | |
| GMP Manufactured Product | |
| Meets ChP Chemical Specifications | |
| Meets B.P. Chemical Specifications | |
| Meets F.C.C. Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Bulk Food Chemical | |
| NF - Assay (as as Mg) (dried basis) | 4.0 - 5.0 % |
| NF - Stearic Acid | ≥ 40 % |
| NF - Stearic and Palmitic Acids | ≥ 90 % |
| 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 (cfu/g) | ≤ 500 |
| NF - Salmonella Species (negative) | Passes Test |
| NF - Escherichia Coli (negative) | Passes Test |
| NF - Loss on Drying at 105°C | ≤ 6.0 % |
| Specific Surface Area, m²/g | 5.0 - 10.0 |
| NF - Limit of Cl | ≤ 0.1 % |
| NF - Limit of SO4 | ≤ 1.0 % |
| NF - Cd | ≤ 3 ppm |
| NF - Pb | ≤ 10 ppm |
| NF - Ni | ≤ 5 ppm |
| EP/BP - Identification C | Passes Test |
| EP/BP - Identification D | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/ BP - Cl | ≤ 0.1 % |
| EP/BP - SO₄ | ≤ 1.0 % |
| EP/BP - Cd | ≤ 3 ppm |
| EP/BP - Pb | ≤ 10 ppm |
| EP/BP - Ni | ≤ 5 ppm |
| EP/BP - Loss on Drying at 105°C | ≤ 6.0 % |
| Total Aerobic Microbial Count (cfu/g) | ≤ 1000 |
| 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 Mold and Yeast Count (cfu/g) | ≤ 100 |
| JP - Identification | Passes Test |
| JP - Acidity or Alkalinity | Passes Test |
| JP - Cl | ≤ 0.1 % |
| JP - SO₄ | ≤ 1.0 % |
| JP - Heavy Metals as Pb | ≤ 20 ppm |
| JP - Stearic Acid | ≥ 40 % |
| JP - Stearic and Palmitic Acids | ≥ 90 % |
| JP - Loss on Drying at 105°C | ≤ 6.0 % |
| JP - Microbiological | Passes Test |
| JP - Total Aerobic Microbial Count (cfu/g) | ≤ 1000 |
| JP - Total Mold and Yeast Count (cfu/g) | ≤ 500 |
| JP - Salmonella Species (negative) | Passes Test |
| JP - Escherichia Coli (negative) | Passes Test |
| JP - Assay (as as Mg) (dried basis) | 4.0 - 5.0 % |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Assay (as MgO) | 6.8 - 8.3 % |
| FCC - Pb | ≤ 5 mg/kg |
| FCC - Loss on Drying at 105°C | ≤ 4.0 % |
| Thru U.S. No. 325 Sieve, For Information Only | |
| Tapped Density (g/cc) | 0.21 - 0.33 |
| Apparent (Bulk) Density | 0.07 - 0.17 g/cm3 |
| Particle Size (50th percentile) (µm) | 10.5 - 16.5 |
| Particle Size (90th percentile) (µm) | ≤ 35 |
| ChP - Identification 1 | Passes Test |
| ChP - Identification 2 | Passes Test |
| ChP - Acidity or Alkalinity | Passes Test |
| ChP - Chlorides (Cl) | ≤ 0.10 % |
| ChP - Sulfates (SO₄) | ≤ 0.6 % |
| ChP - Loss on Drying @ 80° C | ≤ 5.0 % |
| ChP - Iron (Fe) | ≤ 0.01 % |
| ChP - Cadmium (Cd) | ≤ 0.0003 % |
| ChP - Nickel (Ni) | ≤ 0.0005 % |
| ChP - Heavy metals | ≤ 0.001 % |
| ChP - Stearic Acid | ≥ 40.0 % |
| ChP - Stearic and Palmitic Acids | ≥ 90.0 % |
| ChP - Total Aerobic Microbial Count | ≤ 1000 cfu/g |
| ChP - Total Yeast and Mold | ≤ 100 cfu/g |
| ChP - Salmonella | None Detected |
| ChP - Escherichia Coli | None Detected |
| ChP - Assay (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. |
Unit Qty: ea
Availability: 1.001 in stock