Specification 1.00987.2500 Benzyl alcohol special grade (benzaldehyde < 0.05%) suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,NF Specification ‘Assay (GC) ye0-1005 -% Identity (FR) conforms ‘Appearance of solution (nephelometic) conforms Canty of solution conforms Colour of solution conforms Acidity conforms, Refractive index (n 20/0) 1.598 - 1.541 Density (4 20 °c/20 °C) 1.083 - 1.049 Peroxide valve 50 Related substances (GC) (Benzaldehyde $0.05, % (Impurity A)) Related substances (6C) 0.10 % (Cycionexyimetnanal (Impurity 8) Related substances (6C) (Sum of peaks with $0.02 % 2 relative retention less than that of benzyl ‘lcoho)) Related substances (GC) (Sum of peaks with $0.20 % 2 relative retention greater than that of benzyl ‘lcoho)) Related substances (GC) (disregard mt) < 0.0001. % Benzene (GO) <0.0002 % CChlorobenzene (GC) 001 % Toluene (GC) 001 % (Other residual solvents (ICH 30) excluded by manufacturing process Evaporation residue 0.050 % Water sot % Bacterial endotoxins 25 Lust “Total aerobic microbial count (TAMC) 100 cFuig ‘Total combined yeastsimoulds count (TYMC) < 10 cFulg Bile-tolerant gram-negative bacteria passes test (absentin 1 9) Candida albicans (absent in 1 9) passes test Escherichia col (absent in tg) passes test Pseudomonas aeruginosa passes test (absentin 1 9) Salmonella (absent in 10 g) passes test Merck KGaA, Frankfurter Strate 250, 64293 Darmstadt (Germany): +49 6151 72.0 Page 1 of 2 EMD Millipore Corporation -A division of Merck KGaA, Darmstadt, Germany 290 Concord Road, Bilric, MA 01821, USA, Phone: (978) 715-4321Specification 1.00987.2500 Benzyl alcohol special grade (benzaldehyde < 0.05%) suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,NF ‘Staphylococcus aureus passes test (bsentin 1 9) Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. ‘Conforms to Ph Eur, BP, JP, NF Dr. Michael Savelsberg ‘Response laborer mania qual Sonal ‘This document has been produced electronically and is valid without a signature Merck KGaA, Frankfurter Strate 250, 64293 Darmstadt (Germany): +49 6151 72.0 Page 2 of 2 EMD Millipore Corporation - A division of Merck KGaA, Darmstadt, Germany 200 Concord Road, Bilerica, MA 01821, USA, Phone: (978) 715-4321