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1.05980 SAFC

D-Mannitol

EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421

Synonym: Mannite

  • CAS Number 69-65-8

  • Empirical Formula (Hill Notation) C6H14O6

  • Molecular Weight 182.17

  •  Beilstein/REAXYS Number 1721898

  •  MDL number MFCD00064287

  •  E Number E421

  •  EC Index Number 200-711-8

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Controlled Release, Excipients,
Agency/Method   BP
  JP
  Ph. Eur.
  USP
Quality Level   500
reg. compliance   FCC
product line   Emprove® Essential
autoignition temp.   410 °C
potency   13500 mg/kg LD50, oral (Rat)
particle size   20 μm
pH   5-7 (20 °C, 100 g/L in H2O)
bp   290-295 °C/4 hPa
mp   167-170 °C (lit.)
solubility   213 g/L
bulk density   400‑500 kg/m3
SMILES string   OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO
InChI   1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2/t3-,4-,5-,6-/m1/s1
InChI key   FBPFZTCFMRRESA-KVTDHHQDSA-N
storage conditions   no restrictions.

Description

Application

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Biochem/physiol Actions

A sugar alcohol sweet tastant. Used in sweetness inhibition studies.

Analysis Note

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 after hydrolysis/total sugar (as glucose): ≤ 1
Reducing sugars (as glucose): ≤ 0.05
Sulfated ash: ≤ 0.1
Water: ≤ 0.5 %
Loss on Drying (105 °C): ≤ 0.30 %
Particle size (< 20 µm): ≤ 15 %
Particle size (> 212 µm): ≤ 10 %
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
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, USP, JP, FCC, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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