D-(-)-Mannitol 97.0-102.0% Ph. Eur., USP
Supplier: VWR Chemicals
Synonyms:
Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol
25311.297EA
5217
INR
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.
Caution: Not for use as Active Pharmaceutical Ingredient (API)
Formula:
HOH₂C(CH(OH))₄CH₂OH MW: 182,17 g/mol Boiling Pt: 290…295 °C (4 hPa) Melting Pt: 164…169 °C Density: 1,49 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00064287 CAS Number: 69-65-8 EINECS: 200-711-8 Merck Index: 13,05769 |
Specification Test Results
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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