D (+)-Glukos monohydrat 97.5-102.0% USP, Multi-Compendial, J.T.Baker®
Leverantör: Avantor|
Varning
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Synonyms:
(2S,3R,4S,5S,6R)-6-(Hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetraol hydrate, Dextrose monohydrate
1913-07EA
28525
SEK
1913-07
1913-06
1913-01
D (+)-Glukos monohydrat 97.5-102.0% USP, Multi-Compendial, J.T.Baker®
D (+)-Glukos monohydrat
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Formel:
C₆H₁₂O₆·H₂O MW: 198,17 g/mol Smältpunkt: 83 °C Storage Temperature: Omgivande |
MDL Number:
MFCD00149450 CAS nummer: 5996-10-1 EINECS: 200-075-1 |
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Specifikation testresultat
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| Meets J.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets B.P. Chemical Specifications | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | Passes Test |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C: Water (H₂O) | 7.5 - 9.5 % |
| USP - Assay (Anhydrous basis) | 97.5 - 102.0 % |
| USP - Related substances: Maltose and isomaltose | ≤0.4 % |
| USP - Related substances: Maltotriose | ≤0.2 % |
| USP - Related substances: Fructose | ≤0.15 % |
| USP - Related substances: Unspecified impurities, each | ≤0.10 % |
| USP - Related substances: Total Impurities | ≤0.5 % |
| USP - Color and Clarity of Solution | Passes Test |
| USP - Soluble Starch, Sulfites | ≤15 ppm |
| USP - Conductivity (uS cm-1) | ≤20 µS/cm |
| USP - Dextrin | Passes Test |
| USP - Endotoxin Concentration (EU/g) | ≤2.5 |
| EP/BP - Identification A (Specific Rotation (+)) | 52.5 - 53.3 Degree |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification E | Passes Test |
| EP/BP - Assay (C₆H₁₂O₆) (anhydrous substance) | 97.5 - 102.0 % |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Conductivity, uS cm-1 | ≤20 |
| EP/BP - Related Substances: sum of impurities A and B | ≤0.4 % |
| EP/BP - Related Substances: impurity C | ≤0.2 % |
| EP/BP - Related Substances: impurity D | ≤0.15 % |
| EP/BP - Related Substances: unspecified impurities, each | ≤0.10 % |
| EP/BP - Related Substances: total impurities | ≤0.5 % |
| EP/BP - Dextrins | Passes Test |
| EP/BP - Soluble starch, sulfite | ≤15 ppm |
| EP/BP - Water (H₂O) | 7.0 - 9.5 % |
| JP - Identification 1 | Passes Test |
| JP - Identification 2 | Passes Test |
| JP - Water (H2O) | 7.5 - 9.5 % |
| JP - Assay (Anhydrous basis) | 97.5 - 102.0 % |
| JP - Maltose and isomaltose | ≤0.4 % |
| JP - Maltotriose | ≤0.2 % |
| JP - Fructose | ≤0.15 % |
| JP - Unspecified Impurities, each | ≤0.10 % |
| JP - Total Impurities | ≤0.5 % |
| JP - Color and Clarity of Solution | Passes Test |
| JP - Soluble Starch, Sulfites | ≤15 ppm |
| JP - Conductivity (uS cm-1) | ≤20 µS/cm |
| JP - Dextrin | Passes Test |
| JP - Heavy Metals (as Pb) | ≤4 ppm |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
| impurities for this product is available on the associated Product | |
| Regulatory Data Sheet and elemental impurity profile report. |
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