VIVAPUR® Type 102, Microcrystalline Cellulose NF, Ph. Eur., JP Specifications Description Appearance Solubility White or almost white, fine or granular powder Practically insoluble in water, acetone, anhydrous ethanol and toluene, dilute acids and sodium hydroxide solution (50 g / L) Characteristics Bulk density Particle size (retained on air jet sieve) > 250 µm (60 mesh) > 75 µm (200 mesh) > 32 µm (469 mesh) Particle size distribution (laser diffr.) d10 d50 d90 Zinc chloride test (Ident. A (1)) Suspension test (Ident. (2)) Degree of polymerisation (Ident. B (3)) Solubility (Copper tetrammine solution) pH Conductivity Ether-soluble substances Water-soluble substances Loss on drying Sulphated ash / residue on ignition Heavy metals Total aerobic microbial count (TAMC) Total yeasts and molds count (TYMC) E. coli, Pseudomonas aeruginosa Staph. aureus, Salmonella spec. Enterobacteriaceae Additional characteristics Degree of brightness Dark particles (process artifacts) Powder flow – angle of repose Specification 0.28 - 0.33 g / ml Reference NF, JP T226F (MCW) max. 8 % min. 45 % min. 70 % T220F (MCW) 25 – 50 µm 100 – 150 µm 195 – 280 µm passes passes max. 350 passes 5.0 - 7.0 max. 50 µS / cm max. 0.05 % max. 0.24 % max. 7.0 % max. 0.05 % max. 10 ppm max. 100 CFU / g max. 20 CFU / g absent in 10 g absent in 10 g absent in 1 g not specified tested min. 88 % tested max. 9 / 600 cm2 tested max. 42° Ph. Eur., NF, JP JP Ph. Eur., NF, JP Ph. Eur. Ph. Eur., USP, JP Ph. Eur., NF, JP Ph. Eur., NF, JP Ph. Eur., NF, JP Ph. Eur., USP, JP Ph. Eur., USP, JP T252F (MCW) Ph. Eur., USP, JP Ph. Eur., USP, JP Ph. Eur., USP, JP Ph. Eur., USP, JP Ph. Eur. T228F (MCW) T221F (MCW) T222F (MCW) The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur.<5.4>, USP<467>). Re-evaluation date: 4 years from manufacturing date S56102_14 valid as of 2009-04-01
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