Specification 1.41356.1000 Polyvinyl alcohol 28-99 suitable for use as excipient EMPROVE® exp Ph Eur,JPE Specification 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 ethenot) passes test ‘Appearance of solution (40 ll, water) passes test Appearance of solution (50 gil, water) passes test Waterinsoluble matter (40 gf, water) 04 % pH-Value (40 al water) 50-65 Dynamic viscosity (40 gl water) 238-922 Pars Kinomati viscosity (40 gl, water) 238-322 nts [As (Arsenic) <2 pm Hoavy metals (as Pb) <10 om CCrotonaldetyde (GC) <10 ppm ‘Acetic acid (alkalimetric) 505 % Methanol (Gc) 190 % ‘Methyl acetate (60) 510 % (Other residual solvents (ICH Q3C) excluded by production process Ester valve on Degree of hydrolysis (PE) 297 % Acid value 30 ‘Saponifiaton value <30 Sulfated ash s19 % Loss on Drying (105°C) 350 % Endotoxins 5003 Luding ‘Microbiological purty (Total aerobic microbial < 100 Fula count (TAMC)) ‘Microbiological purty (Total yeast and mould < 100 cru count (TYMC)) Bile-tolerant gram-negative bacteria conforms (bsentin 1 9) Escherichia col (absentin tg) conforms Pseudomanes aeruginosa (absentin 11g) conforms ‘Staphylococcus aureus (absent in 1 g) conforms (Candida albicans (absent in 1 9) conforms ‘Salmonella (absent in 10 g) conforms Elemental impurity specifications have been set considering ICH 30 (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 (*. Corresponds to Ph Eur, PE Merck KGaA, Frankfurter Strate 250, 64293 Darmstadt (Germany): +49 6151 72.0 Page 1 of 2 EMD Millipore Corporation -a subsidiary of Merck KGaA, Darmstadt, Germany 290 Concord Road, Billerica, MA 01821, USA, Phone: (978) 715-4321Specification 1.41356.1000 Polyvinyl alcohol 28-99 suitable for use as excipient EMPROVE® exp Ph Eur,JPE Peter S ‘Response lboralany manage qual conial This document has been produced electronically and is valid without a signature, Merck KGaA, Frankfurter Strae 250, 64293 Darmstadt (Germany): +49 6151 72.0 Page 2 of 2 EMD Millipore Corporation -a subsidiary of Merck KGaA, Darmstadt, Germany 280 Concord Road, Billerica, MA 01821, USA, Phone: (978) 715-4321