Polyvinyl alcohol 5-88, EMPROVE® EXPERT Ph. Eur., USP, JPE suitable for use as excipient, SAFC®
Supplier: EMD MILLIPORE – PCS CA EXCEP
Synonyms:
Mowiol®
, Poly(vinyl alcohol)
, PVOH
, PVA
1.41354.9029
1.41354.9029
1.41354.1000
CA1.41354.9029EA
15063.06
CAD
CA1.41354.9029
EM1.41354.1000
EM1.41354.9029
Polyvinyl alcohol 5-88, EMPROVE® EXPERT Ph. Eur., USP, JPE suitable for use as excipient, SAFC®
Polyvinyl alcohol
Formula:
[-CH₂CH(OH)-]n Melting Pt: 160…240 °C Density: 400…670 g/cm³ Storage Temperature: Ambient |
MDL Number:
MFCD00081922 CAS Number: 9002-89-5 |
Specification Test Results
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 |
Water-Insoluble Matter (40 g/l, Water) | ≤0.1% |
pH-Value (40 g/l; Water) | 5.0 - 6.5 |
Viscosity (40 g/l; Water) | 4.3 - 5.7 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 1 g) | Conforms |
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