myo-Inositol 97.0-102.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL Ph. Eur., FCC, NF, SAFC®

Supplier: EMD MILLIPORE – PCS CA EXCEP

Synonyms: Inositolrel-(1R,2r,3S,4R,5s,6S)-Cyclohexane-1,2,3,4,5,6-hexaoli-InositolD-Myo-Inositol

1.04731.9029 1.04731.1000 1.04731.1000
CA1.04731.1000EA 1658.05 CAD
EM1.04731.9029 CA1.04731.1000 EM1.04731.1000
myo-Inositol 97.0-102.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL Ph. Eur., FCC, NF, SAFC®
myo-Inositol

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

Formula: C₆H₁₂O₆
MW: 180.16 g/mol
Boiling Pt: 291 °C (1013 hPa)
Melting Pt: 210 °C
Density: 1.752 g/cm³ (20 °C)
MDL Number: MFCD00077932
CAS Number: 87-89-8
Merck Index: 13,05001

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Specification Test Results

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 %

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