D(-)-Mannitol 98,0-101,0 HPLC-dried, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421 suitable for use as excipient, SAFC®
Leverandør: MERCK PRODUCTION CHEMICALS
Ratings:
Ingen bedømmelse
Samlet vurdering
Gennemsntilig vurdering
Synonymer:
Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol
1.00419.9050
1.00419.9025
1.00419.9050EA
0
DKK
1.00419.9050
1.00419.9025
D(-)-Mannitol 98,0-101,0 HPLC-dried, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421 suitable for use as excipient, SAFC®
D(-)-Mannitol
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (#).
Corresponds to Ph. Eur., BP, JP, USP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
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Formel:
HOH₂C(CH(OH))₄CH₂OH Molekylvægt: 182.17 g/mol Kogepunkt: 290…295 °C (4 hPa) Smeltepunkt: 164…169 °C Massefylde: 1.49 g/cm³ (20 °C) Opbevaringstemperatur: Stue temperatur |
MDL Number:
MFCD00064287 CAS-nummer: 69-65-8 EINECS: 200-711-8 Merck Index: 13,05769 |
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Specifikationer Testresultater
| Assay (HPLC, calc. on dried substance) | 98.0 - 101.0 % |
| Identity (NIR) | passes test |
| Identity (IR-spectrum) | passes test |
| Identity (wet chemistry) | passes test |
| Appearance of solution (13 %; water) | passes test |
| Free acid | passes test |
| pH-value (10 %; water) | 4.5 - 7.5 |
| Melting point | 166 - 169 |
| Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance) | 137 - 145 ° |
| Conductivity (25°C) (20 %; water) | ≤ 20 |
| Arsenic (As) | ≤ 2 |
| Ni (Nickel) (#) | ≤ 1 |
| Pb (Lead) | ≤ 0.5 |
| Chloride (Cl) | ≤ 0.003 % |
| Sulfate (SO₄) | ≤ 0.01 % |
| Heavy metals (as Pb) | ≤ 5 ppm |
| Oxalate (C₂O₄) | ≤ 0.02 % |
| 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 % |
| Residual solvents (ICH Q3C) | excluded by manufacturing process |
| Related substances (HPLC) (Sum of all impurities) | ≤ 2.0 % |
| Reducing sugars after hydrolysis/total sugar (as glucose) | ≤ 1 |
| Reducing sugars (as glucose) | ≤ 0.05 |
| Sulfated ash | ≤ 0.1 |
| Loss on Drying (105 °C) | ≤ 0.30 % |
| Water | ≤ 0.5 % |
| Particle size (< 53 µm) | ≤ 15 % |
| Particle size (> 500 µm) | ≤ 15 % |
| Microbiological test | passes test |
| Colony count (aerobic bacteria (TAMC)) | ≤ 10³ |
| Colony count (Yeasts and moulds (TYMC)) | ≤ 10² |
| Salmonella spp. | in 10 g Substance not detectable |
| E.coli | in 1 g 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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Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (#). |
|
|
Corresponds to Ph. Eur., BP, ChP, JP, USP, E 421 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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