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1.05006 SAFC

Bole white

powder low bacterial content, for internal use EMPROVE® ESSENTIAL Ph Eur,BP

Synonym: Bole white

  • CAS Number 1332-58-7

  •  EC Index Number 310-194-1

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Coatings & Supporting Materials, Excipients,
Agency/Method   BP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
pH   6-7 (20 °C, 50 g/L in H2O, slurry)
density   2.6 g/cm3 at 20 °C
bulk density   470 kg/m3
storage conditions   no restrictions.

Description

General description

powder low bacterial content, for internal use EMPROVE® ESSENTIAL Ph Eur,BP

Application

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

Analysis Note

Identitypasses testSubstances soluble in hydrochloric acid≤ 1 %Acidic or alkaline impuritiespasses testChloride (Cl)≤ 250 ppmSulfate (SO₄)≤ 1000 ppmHeavy metals (as lead)≤ 25 ppmCa (Calcium)≤ 250 ppmOrganic impuritiespasses testAdsorption powerpasses testResidual solvents (ICH Q3C)excluded by production processLoss on ignition (600 °C)≤ 15 %Lumpspasses testMicrobiological purity(Total aerobic microbial count (TAMC))≤ 1000 CFU/gMicrobiological purity(Total yeast and mould count (TYMC))≤ 100 CFU/gBile tolerant Gram negative Bacteria(absent in 1 g)conformsEscherichia coli (absent in 1 g)conformsPseudomonas aeruginosa (absent in 1 g)conformsStaphylococcus aureus (absent in 1 g)conformsCandida albicans (absent in 1 g)conformsSalmonella ssp (absent in 10 g)conformsSwelling powerpasses testResidues of metal catalysts or metal reagents acc. to EMEA/C HMP/SWP/4446/2000 are not likely to be present.conforms to Ph Eur, BP

Legal Information

Emprove 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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