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LC4790 Polyvinyl alcohol 8-88 suitable for use as excipient EMPROVE exp Ph Eur,USP,JPE |
Order number | Packaging | Quantity | Price € |
AC31790 | Plastic bottle | 1 kg | Inquire |
AC31790 | Double PE Sack | 25 kg | Inquire |
Product information | |
Grade | Ph Eur,USP,JPE |
Hill Formula | (C4H6O2 * C2H4O)n |
HS Code | 3905 30 00 |
Storage | Store at +15°C to +25°C. |
CAS number | 25213-24-5 |
Chemical and physical data | |
Ignition temperature | >230 °C |
Solubility | (20 °C) insoluble |
Melting point | >200 °C |
Density | 1.3 g/cm3 (20 °C) |
Bulk density | 400 – 600 kg/m3 |
pH value | 4.5 – 7.0 (40 g/l, H2O, 23 °C) |
Safety information | |
Storage class | 10 – 13 Other liquids and solids |
WGK | WGK 1 slightly water endangering |
Disposal | 3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C |
Toxicological data | |
LD 50 oral | LD50 rat > 2000 mg/kg |
Specifications | |
Identity | passes test |
Appearance of solution | passes test |
Water-insoluble matter | ≤ 0.1 % |
pH-value (4 %; water) | 5.0 – 6.5 |
Viscosity (4 %; water) | 6.8 – 9.2 mPas |
As (Arsenic) | ≤ 2 ppm |
Heavy metals (as Pb) | ≤ 10 ppm |
Crotonaldehyde (HS-GC) | ≤ 10 ppm |
Acetic acid (alkalimetric) | ≤ 0.5 % |
Methanol (HS-GC) | ≤ 1.0 % |
Methyl acetate (HS-GC) | ≤ 1.0 % |
Other residual solvents (Ph.Eur./USP/ICH) | excluded by production process |
Ester value | 130 – 150 |
Degree of hydrolysis | 85 – 89 % |
Acid value | ≤ 3.0 |
Saponification value | 132 – 152 |
Sulfated ash | ≤ 1.0 % |
Loss on drying (105 °C) | ≤ 5.0 % |
Endotoxins | < 0.03 I.U./mg |
Microbiological purity – Total aerobic microbial count (TAMC) |
≤ 1E+02 CFU/g |
– 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 |