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1.02304 SAFC

Calcium hydrogen phosphate

anhydrous extra fine powder suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP,FCC,E 341 (ii)

Synonym: Calcium hydrogen phosphate, Calcium orthophosphate, Calcium phosphate dibasic

  • CAS Number 7757-93-9

  • Molecular Weight 136.06

  •  MDL number MFCD00010909

  •  E Number E341 (ii)

  •  EC Index Number 231-826-1

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Mineral Salts,
Agency/Method   BP
  JP
  Ph. Eur.
  USP
Quality Level   500
reg. compliance   FCC
product line   Emprove® Exp
potency   10000 mg/kg LD50, oral (Rat)
  >7940 mg/kg LD50, skin (Rabbit)
pH   7 (20 °C, 10 g/L in H2O, suspension)
mp   370 °C (decomposition)
solubility   0.1 g/L
density   2.89 g/cm3 at 20 °C
bulk density   900 kg/m3
InChI   1S/Ca.H3O4P/c;1-5(2,3)4/h;(H3,1,2,3,4)/q+2;/p-2
InChI key   FUFJGUQYACFECW-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

General description

anhydrous extra fine powder suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP,FCC,E 341 (ii)

Analysis Note

Assay (complexometric)98.0 - 102.5 %Assay (complexometric; calculated on dried substance)98.0 - 102.0 %Identitypasses testSubstances insoluble in hydrochloric acid≤ 0.2 %Carbonate (as CO₂)passes testChloride (Cl)≤ 0.03 %Fluoride (F)≤ 0.0050 %Sulfate (SO₄)≤ 0.48 %Heavy metals (as Pb)≤ 0.001 %Al (Aluminium)≤ 0.0100 %As (Arsenic)≤ 0.0001 %Ba (Barium)passes testCd (Cadmium)*≤ 0.0001Cr (Chromium)≤ 0.0005 %Fe (Iron)≤ 0.0400 %Hg (Mercury)≤ 0.0001 %Mg (Magnesium)≤ 0.5 %Mn (Manganese)≤ 0.03 %Na (Sodium)≤ 0.05 %Ni (Nickel)*≤ 0.0010Pb (Lead)≤ 0.0001 %Sr (Strontium)≤ 0.03 %V (Vanadium)*≤ 0.0020Residual solvents (ICH Q3C)excluded by manufacturing processLoss on ignition (800 °C)7.0 - 8.5 %Loss on drying≤ 2.0 %Particle Size (d90)≤ 130 µmParticle Size (d50)≤ 70 µmTotal aerobic microbial count≤ 2000 CFU/gTotal yeast and mould count≤ 200 CFU/gElemental 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, JP, USP, FCC, E 341(ii)
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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