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1.05999 SAFC

Manganese(II) sulfate monohydrate

spray dried EMPROVE® ESSENTIAL Ph Eur,USP,FCC

Synonym: Manganese(II) sulfate monohydrate

  • CAS Number 10034-96-5

  • Empirical Formula (Hill Notation) MnO4S · xH2O

  • Molecular Weight 151.00 (anhydrous basis)

  •  MDL number MFCD00149159

  •  EC Index Number 232-089-9

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Mineral Salts, Solid Dosage Forms More...
Agency/Method   Ph. Eur.
  USP
Quality Level   500
reg. compliance   FCC
product line   Emprove® Essential
potency   2150 mg/kg LD50, oral (Rat)
pH   3.0-3.5 (20 °C, 50 g/L in H2O)
mp   >449 °C (anhydrous substance)
density   2.95 g/cm3 at 20 °C
bulk density   1000‑1200 kg/m3
InChI   1S/Mn.H2O4S.H2O/c;1-5(2,3)4;/h;(H2,1,2,3,4);1H2/q+2;;/p-2
InChI key   ISPYRSDWRDQNSW-UHFFFAOYSA-L
storage conditions   Store at +15°C to +25°C.

Description

Analysis Note

Assay (complexometric, MnSO₄·H₂O): 98.0 - 102.0 %
Assay (complexometric, calc. on the ignited basis): 99.0 - 101.0 %
Identity: passes test
Appearance of solution: passes test
Chloride (Cl): ≤ 0.005 %
Heavy metals (as Pb): ≤ 0.002 %
As (Arsenic): ≤ 0.0003 %
Ca (Calcium): ≤ 0.01 %
Co (Cobalt)*: ≤ 0.0002 %
Fe (Iron): ≤ 0.001 %
Ni (Nickel)*: ≤ 0.0005 %
Pb (Lead): ≤ 0.0004 %
Se (Selenium): ≤ 0.003 %
Zn (Zinc): ≤ 0.005 %
Substances not precipitated by ammonium sulfide (as SO₄): ≤ 0.5 %
Residual solvents(Ph Eur/USP/ICH): excluded by manufacturing process
Loss on ignition (500 °C): 10.5 - 12.0 %
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 (*).
conforms to Ph Eur, USP, FCC

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