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1.08197 SAFC

Tabletting aid K (cellulose powder)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,E 460ii

Synonym: Tabletting aid K (cellulose powder)

  • CAS Number 9004-34-6

  • Linear Formula (C6H10O5)n

  •  MDL number MFCD00081512

  •  E Number E460ii

  •  EC Index Number 232-674-9

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Solid Dosage Forms More...
Agency/Method   BP
  JP
  NF
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
autoignition temp.   232 °C
potency   >5000 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rabbit)
particle size   32 μm
pH   5-7.5 (20 °C, 100 g/L in H2O, slurry)
transition temp   flash point 260 °C
density   1.5 g/cm3 at 20 °C
bulk density   70‑400 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

Assay: ≥ 92%
Identity: passes test
Identity (degree of polymerization): 440 - 2250
Ether-soluble substances: ≤ 0.15%
Water-soluble substances: ≤ 1.0%
Solubility: passes test
Suspension test: passes test
pH-value: 5.0 - 7.5
Heavy metals (as Pb): ≤ 0.0010%
Al (Aluminium): ≤ 10 ppm
As (Arsenic): ≤ 3 ppm
Cd (Cadmium): ≤ 1 ppm
Hg (Mercury): ≤ 1 ppm
Pb (Lead): ≤ 1 ppm
Organic impurities: passes test
Residual solvents (ICH Q3C): excluded by production process
Starch, dextrin: passes test
Bulk density: 0.070 - 0.100 g/cm³
Sulfated ash: ≤ 0.3%
Loss on Drying (105 °C): ≤ 6.0%
Particle size (> 32 µm): ≤ 90%
Particle size (> 90 µm): ≤ 35%
Particle size (> 400 µm): ≤ 1%
Particle size (<5µm): ≤ 10%
crystallinity: Nanocrystalline
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): passes test
Escherichia coli (absent in 1 g): passes test
Pseudomonas aeruginosa (absent in 1 g): passes test
Staphylococcus aureus (absent in 1 g): passes test
Candida albicans (absent in 1 g): passes test
Salmonella ssp (absent in 10 g): passes test
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 (*).
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Corresponds to Ph Eur, BP, JP, NF, E 460ii

Legal Information

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

Safety & Documentation

Safety Information

Precautionary statements 

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