Polyvinyl alcohol 26 - 88, EMPROVE® exp Ph. Eur., USP, JPE suitable for use as excipient, hydrolysed, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

Synonyms: Mowiol®PVOHPVA

1.41352.1000EA 782 EUR
1.41352.1000 1.41352.9029
Polyvinyl alcohol 26 - 88, EMPROVE® exp Ph. Eur., USP, JPE suitable for use as excipient, hydrolysed, 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.

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
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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