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1.02052 SAFC

Calcium acetate hydrate

extra pure DAC,FCC

Synonym: Calcium acetate hydrate

  • CAS Number 114460-21-8

  • Linear Formula (CH3COO)2Ca · x H2O

  • Molecular Weight 158.17 (anhydrous basis)

  •  MDL number MFCD00150019

  •  EC Index Number 200-540-9

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Acidulents & pH Adjusters, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Agency/Method   DAC
Quality Level   400
reg. compliance   FCC
form   fine powder
autoignition temp.   680-730 °C
potency   4280 mg/kg LD50, oral (Rat)
pH   7.2-7.8 (20 °C, 50 g/L in H2O)
solubility   400 g/L
density   1.5 g/cm3 at 20 °C
bulk density   400 kg/m3
storage conditions   no restrictions.

Description

Analysis Note

Assay (complexometric, calc. on anhydrous substance): 99.0 - 100.5 %
Identity (Ca): passes test
Identity (Acetate): passes test
Appearance: white to almost white, fine powder
Appearance of solution (100 g/l, CO₂-free water): clear and colorless
pH (50 g/l CO₂-free water): 7.2 - 8.2
Chloride (Cl): ≤ 100 ppm
Fluoride (F): ≤ 50 ppm
Sulfate (SO₄): ≤ 500 ppm
Heavy metals (as Pb): ≤ 10 ppm
As (Arsenic): ≤ 3 ppm
As (Arsenic) (ICP): ≤ 3 ppm
Ba (Barium)*: ≤ 70 ppm
Fe (Iron): ≤ 20 ppm
Fe (Iron) (ICP): ≤ 20 ppm
Pb (Lead): ≤ 2 ppm
Pb (Lead) (ICP): ≤ 2 ppm
Residual solvents (ICH (Q3C)): excluded by manufacturing process
Water (according to Karl Fischer): ≤ 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 (*).
Corresponds to DAC, FCC

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