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1.04731 SAFC

myo-Inositol

EMPROVE® ESSENTIAL Ph Eur,FCC,NF

Synonym: Hexahydroxycyclohexane, Cyclohexanehexol, meso-Inositol, Myo-Inosit, myo-Inositol

  • CAS Number 87-89-8

  • Empirical Formula (Hill Notation) C6H12O6

  • Molecular Weight 180.16

  •  MDL number MFCD00077932

  •  EC Index Number 201-781-2

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Cell Culture Ingredients and Supplements for Biopharmaceutical Manufacturing, Excipients,
Agency/Method   NF
  Ph. Eur.
Quality Level   500
reg. compliance   FCC
product line   EMPROVE® Essential
pH   5-7 (20 °C, 100 g/L in H2O)
mp   225-227 °C
InChI   1S/C6H12O6/c7-1-2(8)4(10)6(12)5(11)3(1)9/h1-12H
InChI key   CDAISMWEOUEBRE-UHFFFAOYSA-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".

Analysis Note

Assay (HPLC, calc.on anhydrous substance): 97.0 - 102.0 %
Identity: conforms
Appearance of solution (10 %; water): passes test
Electrical conductivity: ≤ 20 µS/cm
Melting range (lower value): ≥ 224 °C
Melting range (upper value): ≤ 227 °C
Chloride (Cl): ≤ 0.0050 %
Sulfate (SO₄): ≤ 0.0050 %
Ba (Barium): conforms
Ca (Calcium): conforms
Pb (Lead): ≤ 0.00005 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Related substances/HPLC (EP) (Impurity A): ≤ 0.3 %
Related substances/HPLC (EP) (Impurity B): ≤ 0.3 %
Related substances/HPLC (NF) (Major unspecified impurity): ≤ 0.3 %
Related substances/HPLC (EP) (Major unspecified impurity): ≤ 0.10 %
Related substances/HPLC (EP) (Sum of all impurities): ≤ 1.0 %
Related substances/HPLC (NF) (Sum of all impurities): ≤ 1.0 %
Sulfated ash: ≤ 0.1 %
Loss on Drying (105 °C): ≤ 0.5 %
Water (according to Karl Fischer): ≤ 0.5 %
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, NF, FCC

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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