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1.04228 SAFC

Gum arabic

spray-dried, EMPROVE® ESSENTIAL Ph Eur,BP

Synonym: Acacia, Arabic gum, Gum arabic

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Semisolid Dosage Forms,
Agency/Method   BP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
potency   >16000 mg/kg LD50, oral (Rat)
pH   5 (20 °C, 100 g/L in H2O)
solubility   500 g/L
density   1.4 g/cm3
bulk density   400 kg/m3
storage conditions   Store at +15°C to +25°C.

Description

Application

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Identity: conforms
Glucose and fructose (TLC): conforms
Starch, dextrin and agar: conforms
Sterculia gum: conforms
Tannin: conforms
Tragacantha: conforms
Al (Aluminium): ≤ 5 ppm
Ba (Barium)*: ≤ 70 ppm
Mn (Manganese): ≤ 25 ppm
Residual solvents (ICH Q3C): excluded by production process
Ash: ≤ 4.0 %
Loss on Drying (105 °C): ≤ 10.0 %
Microbiological purity(Total aerobic microbial count (TAMC)): ≤ 1E+03 CFU/g
Microbiological purity(Total yeast and mould count (TYMC)): ≤ 1E+02 CFU/g
Bile tolerant Gram negative Bacteria(absent in 1 g): conforms
Escherichia coli (absent in 1 g): conforms
Pseudomonas aeruginosa (absent in 1 g): conforms
Staphylococcus aureus (absent in 1 g): conforms
Candida albicans (absent in 1 g): conforms
Salmonella ssp (absent in 10 g): conforms
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

Legal Information

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

Safety & Documentation

Safety Information

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