JT Baker® 6321-05 Sucrose (Beet) High Purity Low Endotoxin Parenternal Grade, NF Grade & Multi-Compendial Grade, 1Kg Poly Pail

Item Number:JTB-6321-05
Manufacturer Part No:JT-6321-05
Manufacturer:Avantor
Units:1Kg Poly Pail

Details

  • 1Kg Poly Pail

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 - IdentificationPasses Test
NF - Appearance of SolutionPasses Test
NF - Color Value<= 45
NF - Conductivity<= 35 µS/cm
NF - Optical Rotation (+)66.3 - 67.0 Degree
NF - Reducing SugarsPasses Test
NF - Sulfite (SO2)<= 10 ppm
NF - Loss on Drying at 105 ºC<= 0.1 %
EP/BP - Identification APasses Test
EP/BP - Identification BPasses Test
EP/BP - Identification CPasses Test
EP/BP - Appearance of SolutionPasses Test
EP/BP - Conductivity, uS cm-1<= 35
EP/BP - Optical Rotation (+)66.3 - 67.0 Degree
EP/BP - Colour Value<= 45
EP/BP - Reducing SugarsPasses Test
EP/BP - Sulfite (SO₂)<= 10 ppm
EP/BP - Loss on Drying at 105°C<= 0.1 %
JP - IdentificationPasses Test
JP - Optical Rotation (+)66.3 - 67.0 Degree
JP - Color Value<= 45
JP - Clarity of SolutionPasses Test
JP - DextrinsPasses Test
JP - Sulfite (SO₂)<= 10 ppm
JP - Conductivity, uS cm-1<= 35
JP - Loss on Drying at 105°C<= 0.1 %
JP - Reducing SugarsPasses Test
Assay (HPLC)>= 99 %
Endotoxin Concentration (EU/g)<= 0.6
Microbial Testing - Salmonella (USP)None Detected
Microbial Testing - E. coli (USP)None Detected
Microbial Testing - Staphylococcus aureus (USP)None Detected
Microbial Testing - Pseudomonas aeruginosa (USP)None Detected
Microbial Testing - Total Yeast and Molds (USP)<= 100 cfu/g
Microbial Testing - Total Aerobic Microbial Count (USP)<= 100 cfu/g
Microbial Testing -Bile tolerant gram-negative bacteriaNone Detected
Microbial Testing - Clostridia

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 - IdentificationPasses Test
NF - Appearance of SolutionPasses Test
NF - Color Value<= 45
NF - Conductivity<= 35 µS/cm
NF - Optical Rotation (+)66.3 - 67.0 Degree
NF - Reducing SugarsPasses Test
NF - Sulfite (SO2)<= 10 ppm
NF - Loss on Drying at 105 ºC<= 0.1 %
EP/BP - Identification APasses Test
EP/BP - Identification BPasses Test
EP/BP - Identification CPasses Test
EP/BP - Appearance of SolutionPasses Test
EP/BP - Conductivity, uS cm-1<= 35
EP/BP - Optical Rotation (+)66.3 - 67.0 Degree
EP/BP - Colour Value<= 45
EP/BP - Reducing SugarsPasses Test
EP/BP - Sulfite (SO₂)<= 10 ppm
EP/BP - Loss on Drying at 105°C<= 0.1 %
JP - IdentificationPasses Test
JP - Optical Rotation (+)66.3 - 67.0 Degree
JP - Color Value<= 45
JP - Clarity of SolutionPasses Test
JP - DextrinsPasses Test
JP - Sulfite (SO₂)<= 10 ppm
JP - Conductivity, uS cm-1<= 35
JP - Loss on Drying at 105°C<= 0.1 %
JP - Reducing SugarsPasses Test
Assay (HPLC)>= 99 %
Endotoxin Concentration (EU/g)<= 0.6
Microbial Testing - Salmonella (USP)None Detected
Microbial Testing - E. coli (USP)None Detected
Microbial Testing - Staphylococcus aureus (USP)None Detected
Microbial Testing - Pseudomonas aeruginosa (USP)None Detected
Microbial Testing - Total Yeast and Molds (USP)<= 100 cfu/g
Microbial Testing - Total Aerobic Microbial Count (USP)<= 100 cfu/g
Microbial Testing -Bile tolerant gram-negative bacteriaNone Detected
Microbial Testing - Clostridia