D(+)-Galactose ≥99% (durch HPLC), Multikompendial endotoxinarm, J.T.Baker®
Lieferant: Avantor
Synonyme:
(2R,3S,4S,5R)-Pentahydroxyhexanal
6322-07EA
9254.61
EUR
6322-B1
6322-SA
6322-QM
6322-07
6322-06
6322-05
D(+)-Galactose ≥99% (durch HPLC), Multikompendial endotoxinarm, J.T.Baker®
D(+)-Galactose
|
Formel:
C₆H₁₂O₆ Molecular Weight: 180,16 g/mol Dichte: 1,72 g/cm³ |
MDL:
MFCD00151230 CAS-Nummer: 59-23-4 |
|
Spezifikation Testergebnisse
| Meets B.P. Chemical Specifications | |
| GMP Manufactured Product | |
| Meets E.P. Chemical Specifications | |
| Preserve in well-closed containers. | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| 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 | |
| Trace Impurities - Aluminum (Al), For Information Only | |
| Trace Impurities - Arsenic (As), For Information Only | |
| Trace Impurities - Cadmium (Cd), For Information Only | |
| Trace Impurities - Chromium (Cr), For Information Only | |
| Trace Impurities - Copper (Cu), For Information Only | |
| Trace Impurities - Iridium (Ir), For Information Only | |
| Trace Impurities - Iron (Fe), For Information Only | |
| Trace Impurities - Lead (Pb), For Information Only | |
| Trace Impurities - Manganese (Mn), For Information Only | |
| Trace Impurities - Mercury (Hg), For Information Only | |
| Trace Impurities - Molybdenum (Mo), For Information Only | |
| Trace Impurities - Nickel (Ni), For Information Only | |
| 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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