D-(-)-Mannitol 98.0-101.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL Ph. Eur., BP, JP, USP, E421, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

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

1.00419.9025EA 0 EUR
1.00419.9025 1.00419.9050
D-(-)-Mannitol 98.0-101.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL Ph. Eur., BP, JP, USP, E421, SAFC®
D(-)-Mannitol

Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (#).
Corresponds to Ph. Eur., BP, JP, USP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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
Identity (IR-spectrum) passes test
Identity (wet chemistry) passes test
Appearance of solution (13 %; water) passes test
Free acid passes test
pH-value (10 %; water) 4.5 - 7.5
Melting point 166 - 169
Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance) 137 - 145 °
Conductivity (25°C) (20 %; water) ≤ 20
Arsenic (As) ≤ 2
Ni (Nickel) (#) ≤ 1
Pb (Lead) ≤ 0.5
Chloride (Cl) ≤ 0.003 %
Sulfate (SO₄) ≤ 0.01 %
Heavy metals (as Pb) ≤ 5 ppm
Oxalate (C₂O₄) ≤ 0.02 %
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 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Related substances (HPLC) (Sum of all impurities) ≤ 2.0 %
Reducing sugars after hydrolysis/total sugar (as glucose) ≤ 1
Reducing sugars (as glucose) ≤ 0.05
Sulfated ash ≤ 0.1
Loss on Drying (105 °C) ≤ 0.30 %
Water ≤ 0.5 %
Particle size (< 53 µm) ≤ 15 %
Particle size (> 500 µm) ≤ 15 %
Microbiological test passes test
Colony count (aerobic bacteria (TAMC)) ≤ 10³
Colony count (Yeasts and moulds (TYMC)) ≤ 10²
Salmonella spp. in 10 g Substance not detectable
E.coli in 1 g Substance not detectable
Staphylococcus aureus in 1g Substance not detectable
Pseudomonas aeruginosa in 1g Substance not detectable
Candida albicans In 1g Substance not detectable
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (#).
Corresponds to Ph. Eur., BP, ChP, JP, USP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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