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  • 1.02102 - Calcium lactate pentahydrate

1.02102 SAFC

Calcium lactate pentahydrate


Synonym: Calcium lactate pentahydrate

  • CAS Number 5743-47-5

  • Empirical Formula (Hill Notation) C6H10CaO6 · 5H2O

  • Molecular Weight 308.29

  •  MDL number MFCD00287281

  •  E Number E327

  •  EC Index Number 248-953-3



Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Acidulents & pH Adjusters, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Agency/Method   BP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
form   powder or granules
autoignition temp.   610 °C
potency   3730 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rabbit)
pH   7 (20 °C, 50 g/L in H2O)
mp   240 °C
bulk density   300‑500 kg/m3
InChI   1S/2C3H6O3.Ca.5H2O/c2*1-2(4)3(5)6;;;;;;/h2*2,4H,1H3,(H,5,6);;5*1H2/q;;+2;;;;;/p-2
storage conditions   Store at +15°C to +25°C.


Analysis Note

Assay (complexometric; calculated on dried substance): 98.0 - 101.0 %
Identity (IR-spectrum): passes test
Identity (Calcium): passes test
Identity (Lactat): passes test
Appearance: white to almost white crystalline or granular powder
Appearance of solution (71 g/l; water): almost clear(≤ 6 NTU) and not more intense in colour than reference solution BY₆
Acidity or alkalinity: passes test
pH (71 g/l; water): 6.0 - 8.0
Chloride (Cl): ≤ 200 ppm
Fluoride (F): ≤ 30 ppm
Sulfate (SO₄): ≤ 400 ppm
Heavy metals (as Pb): ≤ 10 ppm
Al (Aluminium): ≤ 50 ppm
As (Arsenic): ≤ 3 ppm
Ba (Barium): passes test
Ba (Barium)*: ≤ 70 ppm
Fe (Iron): ≤ 50 ppm
Hg (Mercury): ≤ 1 ppm
Pb (Lead): ≤ 2 ppm
Magnesium and alcali salts: ≤ 1.0 %
Volatile fatty acids: passes test
Reducing substances: passes test
Residual solvents (ICH Q3C): excluded by production process
Loss on drying (125 °C): 22.0 - 27.0 %
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 Ph Eur, BP, USP, E 327
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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Safety Information

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