Polyvinylalkohol 26 - 88, EMPROVE® EXPERT USP, Ph. Eur., JPE geeignet für die Verwendung als Excipient, hydrolysiert, SAFC®
Lieferant: MERCK PRODUCTION CHEMICALS
Synonyms:
Poly(vinyl alcohol), PVOH, PVA, Mowiol®
1.41352.1000
1.41352.9029
1.41352.1000EA
863
CHF
1.41352.1000
1.41352.9029
Polyvinylalkohol 26 - 88, EMPROVE® EXPERT USP, Ph. Eur., JPE geeignet für die Verwendung als Excipient, hydrolysiert, SAFC®
Polyvinylalkohol
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.
|
Formel:
[-CH₂CH(OH)-]n Melting Pt: 160...240 °C Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00081922 CAS-Nummer: 9002-89-5 |
Spezifikation Testergebnisse
| 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) | 22.1 - 29.9 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% |
| 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 |
| Corresponds to Ph. Eur., USP, JPE |
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