Polyvinyl alcohol 5-88, EMPROVE® EXPERT Ph. Eur., USP, JPE suitable for use as excipient, SAFC®
Catalog # CA1.41354.9029
Supplier: EMD MILLIPORE – PCS CA EXCEP
CAS Number:
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Specifications
- Pack type:PE sack, double
- Size:25 kg
- Cat. no.:CA1.41354.9029
- Supplier No.:1.41354.9029
Specifications
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):4.3 - 5.7 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 1 g):Conforms
Specification Test Results
About this item
:
Melting Pt:160…240 °C
Density:400…670 g/cm³
Storage Temperature:Ambient
CAS Number:9002-89-5
:25213-24-5
Formula:[-CH₂CH(OH)-]n
MDL Number:MFCD00081922