D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®
Supplier: Avantor
6322-05EA
1064.31
EUR
6322-05
6322-06
6322-07
D-(+)-Galactose ≥99% (by HPLC), Multi-Compendial low in endotoxins, J.T.Baker®
D(+)-Galactose
Formula:
C₆H₁₂O₆ Density: 1.72 g/cm³ |
MDL Number:
MFCD00151230 CAS Number: 59-23-4 |
Specification Test Results
Meets B.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets E.P. Chemical Specifications | |
Preserve in well-closed containers. | |
CAUTION: For Manufacturing, processing or repackaging | Passes Test |
Bulk Pharmaceutical Chemical | Passes Test |
NF - Assay (C6H12O6 ) (anhydrous basis) | 98.0 - 102.0 % |
NF - Appearance of Solution | Passes Test |
NF - Acidity | Passes Test |
NF - Identification A (IR) | Passes Test |
NF - Identification B (HPLC) | Passes Test |
NF - Identification C | Passes Test |
NF - Optical Rotation [Å]²ºD (+) | 78.0 - 81.5 Degree |
NF - Related Substances: Lactose and 1,6-galactosylgalactose | ≤ 0.6 % |
NF - Related Substances: Galacturonic acid | ≤ 0.6 % |
NF - Related Substances: Dextrose | ≤ 0.6 % |
NF - Related Substances: Tagatose | ≤ 0.6 % |
NF - Related Substances: Dulcitol | ≤ 0.6 % |
NF - Related Substances: Arabinose | ≤ 0.6 % |
NF - Related Substances: Any unspecified impurity, each | ≤ 0.2 % |
NF - Related Substances: Total impurities | ≤ 1.0 % |
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 Solution | Passes Test |
EP/BP - Acidity or Alkalinity | Passes 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]²ºD (+) | 78.0 - 81.5 Degree |
EP/BP - Water (H₂O) | ≤ 1.0 % |
EP/BP - Sulfated Ash | ≤ 0.1 % |
EP/BP - TAMC (cfu/g) | ≤ 100 cfu/g |
Appearance | Passes 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 | For Information Only |
Trace Impurities - Aluminum (Al), For Information Only | For Information Only |
Trace Impurities - Arsenic (As), For Information Only | For Information Only |
Trace Impurities - Cadmium (Cd), For Information Only | For Information Only |
Trace Impurities - Chromium (Cr), For Information Only | For Information Only |
Trace Impurities - Copper (Cu), For Information Only | For Information Only |
Trace Impurities - Iridium (Ir), For Information Only | For Information Only |
Trace Impurities - Iron (Fe), For Information Only | For Information Only |
Trace Impurities - Lead (Pb), For Information Only | For Information Only |
Trace Impurities - Manganese (Mn), For Information Only | For Information Only |
Trace Impurities - Mercury (Hg), For Information Only |
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Trace Impurities - Molybdenum (Mo), For Information Only |
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Trace Impurities - Nickel (Ni), For Information Only |
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Trace Impurities - Osmium (Os), For Information Only | |
Trace Impurities - Palladium (Pd), For Information Only | |
Trace Impurities - Platinum (Pt), For Information Only | |
Trace Impurities - Rhodium (Rh), For Information Only | |
Trace Impurities - Ruthenium (Ru), For Information Only | |
Trace Impurities - Vanadium (V), For Information Only | |
Trace Impurities - Zinc (Zn), For Information Only | |
Residual Methanol | ≤ 3000 ppm |
Residual Ethanol | ≤ 5000 ppm |
Residual Isopropanol | ≤ 5000 ppm |
Residual Solvents: Only the Class 2 solvent Methanol and the Class 3 | |
Solvent Ethanol are likely to be present. Each is tested and the | |
concentration reported for each batch. | |
Metallic Residues: No metal catalysts or metal reagents, as defined by | |
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
this material. | |
Plant Derived |
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