Parteck® Delta M (Mannitol), EMPROVE® ESSENTIAL Ph. Eur., BP, USP, JP, E421, SAFC®
Synonyms:
Mannitol
, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol
1.12635.1000EA
1200
EUR
1.12635.1000
1.12635.9025
Parteck® Delta M (Mannitol), EMPROVE® ESSENTIAL Ph. Eur., BP, USP, JP, 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 (#).
Certifications: Corresponds to Ph. Eur., BP, USP, JP, 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 |
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 |
Ru (Ruthenium) (#) | ≤ 1 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 % |
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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