Imprimer

Alcool polyvinylique 26 - 88, EMPROVE® EXPERT USP, Ph. Eur., JPE excipient_suitable, hydrolysed, SAFC®

Fournisseur: MERCK PRODUCTION CHEMICALS

Synonyms: Poly(vinyl alcohol), PVOH, PVA, Mowiol®

1.41352.1000 1.41352.9029
1.41352.1000EA 521 EUR
1.41352.1000 1.41352.9029
Alcool polyvinylique 26 - 88, EMPROVE® EXPERT USP, Ph. Eur., JPE excipient_suitable, hydrolysed, SAFC®
Alcool polyvinylique

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.

Formule: [-CH₂CH(OH)-]n
Point de fusion: 160...240 °C
Température de stockage: Température ambiante
Numéro MDL: MFCD00081922
Numéro CAS: 9002-89-5

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Résultats des tests de spécification

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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