Polyvinyl alcohol 4-88, EMPROVE® ESSENTIAL USP, Ph. Eur., ChP, JPE suitable for use as excipient, SAFC®
: Poly(vinyl alcohol), PVOH, PVA, Mowiol®
:9002-89-5
:25213-24-5
:[-CH₂CH(OH)-]n
:MFCD00081922
:160…240 °C
:Ambient
- Environmentally Preferable:
- Identity (IR spectrum):passes test
- Identity (Viscosity):passes test
- Identity (Reaction with iodine):passes test
- Identity (Reaction with iodine and boric acid):passes test
- Identity (Reaction with ethanol):passes test
- Appearance of solution (40 g/l, water):passes test
- Appearance of solution (50 g/l, water):passes test
- Water-insoluble matter (40 g/l, water):≤ 0.1 %
- pH-Value (40 g/l; water):5.0 - 6.5
- Viscosity (40 g/l; water):3.4 - 4.6 mPa∙s
- As (Arsenic):≤ 2 ppm
- Heavy metals (as Pb):≤ 10 ppm
- Crotonaldehyde (GC):≤ 10 ppm
- Acetic acid (alkalimetric):≤ 0.5 %
- Methanol (GC):≤ 1.0 %
- Methyl acetate (GC):≤ 1.0 %
- Other residual solvents (ICH Q3C):excluded by production process
- Ester value:130 - 150
- Degree of hydrolysis (USP):85 - 89 %
- Degree of hydrolysis (JPE):78 - 96 %
- 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)):≤ 100 CFU/g
- Microbiological purity (Total yeast and mould count (TYMC)):≤ 100 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 (absent in 10 g):conforms
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