Macron™ 5712-26 Magnesium Stearate Hyqual® (Vegetable), GenAR® BioReagent Grade, NF Grade, 40Kg Poly Drum

Item Number:MAL-5712-26
Manufacturer Part No:MK-5712-26
Manufacturer:Avantor
Units:40Kg Poly Drum

Details

  • 40Kg Poly Drum

Product Specifications

TESTSPECIFICATION
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 APasses Test
NF - Identification BPasses Test
NF - Acidity or AlkalinityPasses Test
NF - MicrobiologicalPasses 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/g6.0 - 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 AlkalinityPasses 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 - IdentificationPasses Test
JP - Acidity or Alkalinity

Product Specifications

TESTSPECIFICATION
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 APasses Test
NF - Identification BPasses Test
NF - Acidity or AlkalinityPasses Test
NF - MicrobiologicalPasses 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/g6.0 - 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 AlkalinityPasses 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 - IdentificationPasses Test
JP - Acidity or Alkalinity