D(-)-Mannitol, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421 suitable for use as excipient, SAFC®
Lieferant: Merck
Synonyme:
(2R,3R,4R,5R)-(-)-1,2,3,4,5,6-Hexanhexol, D(-)-Mannit
1.00494.9025
1.00494.9025EA
0
EUR
1.00494.9025
D(-)-Mannitol, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421 suitable for use as excipient, SAFC®
D(-)-Mannitol
Formel:
HOH₂C(CH(OH))₄CH₂OH Molecular Weight: 182.17 g/mol Siedepunkt: 290…295 °C (4 hPa) Schmelzpunkt: 164…169 °C Dichte: 1.49 g/cm³ (20 °C) Lagertemperatur: Raumtemperatur |
MDL:
MFCD00064287 CAS-Nummer: 69-65-8 EINECS: 200-711-8 Merck Index: 13,05769 |
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Spezifikation Testergebnisse
Assay (HPLC, calc. on dried substance) | 98.0 - 101.0 % |
Identity (NIR) | passes test |
Appearance of solution (10 %; water) | passes test |
pH-value (10 %; water) | 4.5 - 7.5 |
Melting point | 165 - 169 |
Conductivity (25°C) (20 %; water) | ≤ 20 |
Heavy metals (as Pb) | ≤ 5 ppm |
Ni (Nickel) (#) | ≤ 1 ppm |
Pb (Lead) | ≤ 0.5 ppm |
Related substances (HPLC) (Sorbitol (Impurity A)) | ≤ 2.0 % |
Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C)) | ≤ 2.0 |
Related substances (HPLC) (Major unspecified impurity) | ≤ 0.10 % |
Related substances (HPLC) (Sum of all impurities) | ≤ 2.0 % |
Reducing sugars (as glucose) | ≤ 0.05 |
Reducing sugars after hydrolysis/total sugar (as glucose) | ≤ 1 |
Sulfated ash | ≤ 0.1 |
Water | ≤ 0.5 % |
Loss on Drying (105 °C) | ≤ 0.30 % |
Particle size (> 212 µm) | ≤ 20 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Microbiological test | passes test |
Colony count (aerobic bacteria (TAMC)) | ≤ 10³ |
Colony count (Yeasts and moulds (TYMC)) | ≤ 10² |
Salmonella spp. | in 10g Substance not detectable |
E.coli | in 1g Substance not detectable |
Staphylococcus aureus | in 1g Substance not detectable |
Pseudomonas aeruginosa | in 1g Substance not detectable |
Candida albicans | In 1g Substance not detectable |
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