D (-)-Mannitol 97.0-102.0% Ph. Eur., USP
Leverantör: VWR Chemicals
Synonyms:
Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol
25311.297EA
1225
SEK
25311.297
25311.366
25311.468
D (-)-Mannitol 97.0-102.0% Ph. Eur., USP
D (-)-Mannitol
Appearance: White or almost white crystals or powder.
Observera: Not for use as Active Pharmaceutical Ingredient (API)
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Formel:
HOH₂C(CH(OH))₄CH₂OH MW: 182,17 g/mol Kokpunkt: 290…295 °C (4 hPa) Smältpunkt: 164…169 °C Densitet: 1,49 g/cm³ (20 °C) Storage Temperature: Omgivande |
MDL Number:
MFCD00064287 CAS nummer: 69-65-8 EINECS: 200-711-8 Merck Index: 13,05769 |
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Specifikation testresultat
| Appearance | Conforms (see CoA/CoS) |
| Heavy metals (as Pb) | Max. 5 ppm |
| Residual solvents | Unlikely by manuf.process |
| Metal catalysts | Unlikely by manuf.process |
| As (Arsenic) | Max. 2 ppm |
| Cd (Cadmium) | Max. 1 ppm |
| Co (Cobalt) | Max. 1 ppm |
| Hg (Mercury) | Max. 2 ppm |
| Pb (Lead) | Max. 3 ppm |
| V (Vanadium) | Max. 1 ppm |
| Conforms to Ph.Eur./USP | Passes test |
| Ph.Eur. specifications: | Max. 2.0 % |
| Assay (dried substance) [Ph.Eur.] | 97.0 --> 102.0 % |
| Identification C | Passes test Ph.Eur. |
| Appearance of solution | Passes test USP |
| Conductivity (20°C; 20 %) [Ph.Eur.] | Max. 20 μS/cm |
| Melting point [Ph.Eur.] | 165 --> 170 °C |
| Reducing sugars (as C6H12O6) [Ph.Eur.] | Max. 0.1 % |
| D-Sorbitol [Ph.Eur.] | Max. 2.0 % |
| D-Maltitol and isomalt [Ph.Eur.] | Max. 2.0 % |
| Unspecified impur. (for each) [Ph.Eur.] | Max. 0.10 % |
| Total impurities [Ph.Eur.] | Max. 2.0 % |
| Disregard limit [Ph.Eur.] | Max. 0.05 % |
| Loss on drying (105°C; 4 h) [Ph.Eur.] | Max. 0.5 % |
| TAMC [Ph.Eur.] | Max. 1000 CFU/g |
| TYMC [Ph.Eur.] | Max. 100 CFU/g |
| Escherichia coli [Ph.Eur.] | Absent |
| Salmonella [Ph.Eur.] | Absent |
| USP specifications: | |
| Assay (calculated on dried basis) [USP] | 97.0 --> 102.0 % |
| Identification A | Passes test USP |
| Disregard limit [USP] | Max. 0.05 % |
| Sorbitol [USP] | Max. 2.0 % |
| Sum of isomalt and maltitol [USP] | Max. 2.0 % |
| Unspecified impurities [USP] | Max. 0.10 % |
| Total impurities [USP] | Max. 2.0 % |
| Reducing sugars (as C6H12O6) [USP] | Max. 0.1 % |
| Ni (Nickel) [USP] | Max. 1 μg/g |
| Melting point [USP] | 165 --> 170 °C |
| Loss on drying (105°C; 4 h) [USP] | Max. 0.5 % |
| Conductivity (25°C; 20 %) [USP] | Max. 20 μS/cm |
| TAMC [USP] | Max. 1000 CFU/g |
| TYMC [USP] | Max. 100 CFU/g |
| Escherichia coli [USP] | Absent |
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