JT Baker® 6322-07 D-(+)-Galactose High Purity Low Endotoxin, NF Grade, Multi-Compendial Grade, 12Kg Poly Drum

  • 12Kg Poly Drum
  • Manufacturer Part No: JT-6322-07
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Item Number: JTB-6322-07
$18,794.83

Sold in: Drums

UnitMSRPYour PriceStock StatusQty
Drum20,332.5718,794.83Lead Time

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Details

Product Specifications

TESTSPECIFICATION
GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Preserve in well-closed containers.
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
NF - Appearance of SolutionPasses Test
NF - AcidityPasses Test
NF - Identification A (IR)Passes Test
NF - Identification B (TLC)Passes Test
NF - Optical Rotation [Å]²º^D (+)78.0 - 81.5 Degree
NF - Barium (Ba)Passes Test
NF - Lead (Pb)<= 0.5 ppm
NF - Water (H₂O)<= 1.0 %
NF - Residue on Ignition<= 0.1 %
EP/BP - Assay (C₆H₁₂O₆)(anhydrous basis)97.0 - 102.0 %
EP/BP - Appearance of SolutionPasses Test
EP/BP - Acidity or AlkalinityPasses Test
EP/BP - Identification A (IR)Passes Test
EP/BP - Proteins<= 0.1 %
EP/BP - Related Substances: Sum of Impurities A and B<= 1.0 %
EP/BP - Related Substances:Unspecified impurities, each<= 0.3 %
EP/BP - Related Substances:Total impurities<= 2.0 %
EP/BP - Specific Optical Rotation [Å]²º^D (+)78.0 - 81.5 Degree
EP/BP - Barium (Ba)Passes Test
EP/BP - Lead (Pb)<= 0.5 ppm
EP/BP - Water (H₂O)<= 1.0 %
EP/BP - Sulfated Ash<= 0.1 %
EP/BP - TAMC (cfu/g)<= 100 cfu/g
AppearancePasses Test
Endotoxin Concentration (EU/g)<= 2.5
Glucose<= 0.1 %
Purity (HPLC)>= 99 %
Residue on Ignition<= 0.05 %
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 Mold (USP)<= 100 cfu/g
Microbial Testing - Total Aerobic Microbial Count (USP)<= 100 cfu/g
Solution Clarity (300 mg/mL)Passes Test
Solution Color, APHA - For Information Only
Trace Impurities - Aluminum (Al), For Information Only
Trace Impurities - Arsenic (As), For Information Only

Product Specifications

TESTSPECIFICATION
GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Preserve in well-closed containers.
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
NF - Appearance of SolutionPasses Test
NF - AcidityPasses Test
NF - Identification A (IR)Passes Test
NF - Identification B (TLC)Passes Test
NF - Optical Rotation [Å]²º^D (+)78.0 - 81.5 Degree
NF - Barium (Ba)Passes Test
NF - Lead (Pb)<= 0.5 ppm
NF - Water (H₂O)<= 1.0 %
NF - Residue on Ignition<= 0.1 %
EP/BP - Assay (C₆H₁₂O₆)(anhydrous basis)97.0 - 102.0 %
EP/BP - Appearance of SolutionPasses Test
EP/BP - Acidity or AlkalinityPasses Test
EP/BP - Identification A (IR)Passes Test
EP/BP - Proteins<= 0.1 %
EP/BP - Related Substances: Sum of Impurities A and B<= 1.0 %
EP/BP - Related Substances:Unspecified impurities, each<= 0.3 %
EP/BP - Related Substances:Total impurities<= 2.0 %
EP/BP - Specific Optical Rotation [Å]²º^D (+)78.0 - 81.5 Degree
EP/BP - Barium (Ba)Passes Test
EP/BP - Lead (Pb)<= 0.5 ppm
EP/BP - Water (H₂O)<= 1.0 %
EP/BP - Sulfated Ash<= 0.1 %
EP/BP - TAMC (cfu/g)<= 100 cfu/g
AppearancePasses Test
Endotoxin Concentration (EU/g)<= 2.5
Glucose<= 0.1 %
Purity (HPLC)>= 99 %
Residue on Ignition<= 0.05 %
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 Mold (USP)<= 100 cfu/g
Microbial Testing - Total Aerobic Microbial Count (USP)<= 100 cfu/g
Solution Clarity (300 mg/mL)Passes Test
Solution Color, APHA - For Information Only
Trace Impurities - Aluminum (Al), For Information Only
Trace Impurities - Arsenic (As), For Information Only

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