D(-)-Mannitol 97,0-102,0%, Pulver, GenAR® USP für die Biotechnologie, Macron Fine Chemicals™
Lieferant: Avantor
Synonyms:
D(-)-Mannit
, (2R,3R,4R,5R)-(-)-1,2,3,4,5,6-Hexanhexol
Veränderungsmanagement-Kategorie= R
7781-04EA
0
CHF
7781-04
7781-88
D(-)-Mannitol 97,0-102,0%, Pulver, GenAR® USP für die Biotechnologie, Macron Fine Chemicals™
D(-)-Mannitol
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Formel:
HOH₂C(CH(OH))₄CH₂OH MW: 182,17 g/mol Siedepunkt: 290…295 °C (4 hPa) Melting Pt: 164…169 °C Dichte: 1,49 g/cm³ (20 °C) Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00064287 CAS-Nummer: 69-65-8 EINECS: 200-711-8 Merck Index: 13,05769 |
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Spezifikation Testergebnisse
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (dried basis) | 97.0 - 102.0 % |
| USP - Identification | Passes Test |
| USP - Related Substances: Sorbitol | ≤ 2.0 % |
| USP - Related Substances: Sum of isomalt& maltitol | ≤ 2.0 % |
| USP - Related Substances: Unspecified impurities | ≤ 0.10 % |
| USP - Related Substances: Total impurities | ≤ 2.0 % |
| USP - Loss on Drying at 105°C | ≤ 0.5 % |
| USP - Melting Point | 165 - 170 °C |
| USP - Reducing Sugars | ≤ 0.1 % |
| USP - Nickel (Ni) | ≤ 1 ppm |
| USP - Appearance of Solution | Passes Test |
| USP - Conductivity (uS cm-1) | ≤ 20 µS/cm |
| USP - Total Aerobic Microbial Count | ≤ 100 cfu/g |
| USP - Total Yeast and Mold Count | ≤ 100 cfu/g |
| USP - Escherichia coli | Passes Test |
| EP/BP - Assay (as C₆H₁₄O₆) (calculated on anhydrous basis) | 97.0 - 102.0 % |
| EP/BP - Conductivity, uS cm-1 | ≤ 20 |
| EP/BP - Identification C | Passes Test |
| EP/BP - Melting Point | 165 - 170 °C |
| EP/BP - Loss on Drying | ≤ 0.5 % |
| EP/BP - Reducing Sugars | ≤ 0.1 % |
| EP/BP - Related Substances: Impurity A | ≤ 2.0 % |
| EP/BP - Related Substances: Sum of Impurities B & C | ≤ 2.0 % |
| EP/BP - Related Substances: Unspecified Impurities, each | ≤ 0.10 % |
| EP/BP - Related Substances: Total Impurities | ≤ 2.0 % |
| EP/BP - Appearance of Solution | Passes Test |
| Total Aerobic Microbial Count (cfu/g) | ≤ 1000 |
| Total Mold and Yeast Count (cfu/g) | ≤ 100 |
| EP/BP - Escherichia coli (absent) | Passes Test |
| Salmonella (absent) | Passes Test |
| Endotoxin Concentration (EU/g) | ≤ 10 |
| Appearance (fine, white crystalline powder) | |
| Not Intended for Parenteral Use | |
| Only Class 2 solvents (Ethylene Glycol) are likely to be present. All | |
| are below Option 1 limits. | |
| 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. |
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