(Montanglycolwax pharmaceutical)
Article: 1008
Parameter | Limit | Unit | Method |
Density (20°C) | 1,01 - 1,03 | g/cm³ | DAB 2.2.N1 |
Drop point | 79 - 85 | °C | Ph. Eur. 2.2.17 |
Acid value | 15 - 20 | KOH mg/g | DAB |
Peroxide value | max. 5,0 | meq O2/kg | DAB |
Saponification value | 130 - 160 | KOH mg/g | DAB |
Free ethylene glycol | max. 0,3 | % | GC, DAB |
Chrome (lll) | max. 10 | ppm | Ph. Eur. 2.2.23 II |
Ash | max. 0,3 | g/100g | Ph. Eur. 2.4.16 |
Appearance of solution | max. 20 *) | Jodfarbzahl (Lange) | |
Characters | DAB | ||
Microbiological testing: | |||
Total Bacterial count | < 10³ | KBE/g | Ph. Eur. 2.6.12 |
Yeasts/Moulds | < 10² | KBE/g | Ph. Eur. 2.6.12 |
Pseudomonas aeroginosa | negative | Ph. Eur. 2.6.13 | |
Staphylococcus aureus | negative | Ph. Eur. 2.6.13 | |
Particle size distribution **) | AA 3.2.1.530 intern | ||
max. 125 µm | min. 85,00 | % | |
max. 250 µm | min. 95,00 | % | |
max. 500 µm | 95,00 - 100,00 | % | |
Bile-tolerant gram-negative bacteria | negative | Ph. Eur. 2.6.13 |
INCI | Glycol Montanate |
CAS | 73138-45-1 |
EINECS | 277-291-8 |
CoS /TSE | |
Customs tarif no. | 3404 90 00 |
WARADUR XE is widely used for the polishing of dragées. The raw material is plant derived and extracted from brown-coal. *) The limit of the parameter "colour" is lighter than the colour reference sample "G4", mentioned in DAB parameter "Aussehen der Loesung". **) Particle size distribution is just for information and not part of the delivery specification.
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