D(-)-Mannitol, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, E421 suitable for use as excipient, SAFC®

1.00494.9025

1.00494.9025

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

: Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol

:182.17 g/mol

:290…295 °C (4 hPa)

:164…169 °C

:1.49 g/cm³ (20 °C)

:Température ambiante

:200-711-8

:69-65-8

:HOH₂C(CH(OH))₄CH₂OH

:MFCD00064287

:13,05769