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1.02144 SAFC

Calcium hydrogen phosphate

anhydrous extra fine powder EMPROVE® ESSENTIAL Ph Eur,BP,USP,FCC,E 341 (ii)

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

  • CAS Number 7757-93-9

  • Empirical Formula (Hill Notation) HCaO4P

  • 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
  Ph. Eur.
  USP
Quality Level   500
reg. compliance   FCC
product line   Emprove® Essential
form   extra fine powder
potency   10000 mg/kg LD50, oral (Rat)
  >7940 mg/kg LD50, skin (Rabbit)
particle size   63 μm
pH   7 (20 °C, 10 g/L in H2O, suspension)
mp   370 °C (decomposition)
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 +15°C to +25°C.

Description

General description

To address challenges of solid formulation manufacturing, we have developed a comprehensive product portfolio to meet with your solid dosage needs in mind. Although solid dose formulations are one of the the most established dosage forms in the pharmaceutical market, the complexity of manufacturing final drug products is becoming more and more challenging. API stability, release kinetics and bioavailability limitations, such as low API solubility, are just a few of many critical obstacles on the way to the market.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Calcium hydrogen phosphate is a commonly used ingredient in both food and pharmaceutical applications. In pharmaceutical applications, calcium hydrogen phosphate is primarily used as a filler/binder.
The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Identity: passes test
Assay (complexometric): 98.0 - 102.5 %
Assay (complexometric; calculated on dried substance): 98.0 - 102.0 %
Substances insoluble in hydrochloric acid: ≤ 0.2 %
Carbonate (as CO₂): passes test
Chloride (Cl): ≤ 0.03 %
Fluoride (F): ≤ 0.0050 %
Sulfate (SO₄): ≤ 0.5 %
Heavy metals (as Pb): ≤ 0.001 %
Al (Aluminium): ≤ 0.0200 %
As (Arsenic): ≤ 0.0001 %
Ba (Barium): passes test
Cd (Cadmium)*: ≤ 0.0001 %
Fe (Iron): ≤ 0.0400 %
Hg (Mercury): ≤ 0.0001 %
Mg (Magnesium): ≤ 0.5 %
Mn (Manganese): ≤ 0.03 %
Na (Sodium): ≤ 0.05 %
Ni (Nickel)*: ≤ 0.0010
Pb (Lead)*: ≤ 0.0001 %
Sr (Strontium): ≤ 0.03 %
V (Vanadium)*: ≤ 0.0010
Residual solvents (ICH Q3C): excluded by production process
Loss on ignition (800 °C): 7.0 - 8.5 %
Loss on drying: ≤ 2.0 %
Particle size (< 63 µm): about 99 %
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,FCC,E341 (ii)
Conforms to the purity criteria on food additives, except for use as additive in infant and young child nutrition, according to the current European Commission Regulation.

Legal Information

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

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

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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