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:
Inositol
, rel-(1R,2r,3S,4R,5s,6S)-Cyclohexane-1,2,3,4,5,6-hexaol
, i-Inositol
, D-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 |
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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