Polyvinyl alkohol 4-88, EMPROVE® ESSENTIAL USP, Ph. Eur., ChP, JPE suitable for use as excipient, SAFC®
Leverandør: MERCK PRODUCTION CHEMICALS
Ratings:
Ingen bedømmelse
Samlet vurdering
Gennemsntilig vurdering
Synonymer:
PVOH, PVA, Mowiol®
1.41350.1000
1.41350.9029
1.41350.1000EA
6350
DKK
1.41350.1000
1.41350.9029
Polyvinyl alkohol 4-88, EMPROVE® ESSENTIAL USP, Ph. Eur., ChP, JPE suitable for use as excipient, SAFC®
Polyvinyl alkohol
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 (*).
Certificeringer: Corresponds to Ph Eur,USP,JPE
|
Formel:
[-CH₂CH(OH)-]n Smeltepunkt: 160…240 °C Opbevaringstemperatur: Stue temperatur |
MDL Number:
MFCD00081922 CAS-nummer: 9002-89-5 |
Specifikationer Testresultater
| 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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