D(-)-Mannitol 97,0-102,0% Ph. Eur., USP

: VWR Chemicals

D(-)-Mannitol 97,0-102,0% Ph. Eur., USP

: VWR Chemicals

:69-65-8

:HOH₂C(CH(OH))₄CH₂OH

:MFCD00064287

:182.17 g/mol

:13,05769

:290…295 °C (4 hPa)

:164…169 °C

:1.49 g/cm³ (20 °C)

:Raumtemperatur

:200-711-8

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 Ph.Eur.
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
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

25311_MANNITOL PH.EUR_BSE_Rev1.pdf

25311_MANNITOL PH.EUR_GMO.Rev1.pdf

D-(-)-Mannitol 97 - 102% Ph. Eur., USP

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