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Polyvinyl alcohol 4-88, EMPROVE® ESSENTIAL Ph. Eur., ChP, USP, JPE, SAFC®

Supplier: EMD MILLIPORE - PCS - GPS

1.41350.1000 1.41350.9029
EM1.41350.1000CS 3978.78 USD InStock
EM1.41350.1000 EM1.41350.9029
Polyvinyl alcohol 4-88, EMPROVE® ESSENTIAL Ph. Eur., ChP, USP, JPE, SAFC®
Polyvinyl alcohol
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 (*).

Certificaciones: Corresponds to Ph. Eur.,USP,JPE


Formula: [-CH₂CH(OH)-]n
Melting Pt: 160...240 °C
Storage Temperature: Ambient
 MDL Number: MFCD00081922
CAS Number: 9002-89-5
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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
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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