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1.05911 SAFC

Maltose monohydrate

EMPROVE® ESSENTIAL

Synonym: Maltose monohydrate

  • CAS Number 6363-53-7

  • Empirical Formula (Hill Notation) C12H22O11 · xH2O

  • Molecular Weight 342.30 (anhydrous basis)

  •  MDL number MFCD00149343

  •  EC Index Number 200-716-5

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Solid Dosage Forms,
Quality Level   500
product line   Emprove® Essential
assay   ≥95.0% (HPLC)
pH   4.5-6.0 (20 °C, 50 g/L in H2O)
mp   125 °C (anhydrous)
bulk density   320 kg/m3
storage conditions   Store at +15°C to +25°C.

Description

Application

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

Analysis Note

Purity (HPLC): ≥ 95.0 %
Identity (IR): passes test
Appearance of solution (clearness): passes test
Appearance of solution (color): passes test
pH-value (5 %; water; 20 °C): 4.5 - 6.0
Spec. rotation [α²0/D (10 %; water; calc. on anhydrous substance): 135.0 - 139.0 °
Heavy metals (as Pb): ≤ 0.002 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Sulfated ash: ≤ 0.1 %
Water: 4.0 - 7.0 %
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 (*).

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.

Emprove® Dossiers

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