D-(-)-Mannitol, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, JP, E421, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

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

1.00494.9025EA 0 EUR
1.00494.9025
D-(-)-Mannitol, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, JP, E421, SAFC®
D(-)-Mannitol
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
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Specification Test Results

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

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