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MICROCRYSTALLINE CELLULOSE

SANCEL-102

 Parameters  IP  USP - NF
 Appearance  Fine or granular, white or almost white powder, free flowing  Fine or granular, white or almost white powder, free flowing
 Identification 
 A  Comply  Comply
 B + C  Comply  Not Applicable
 B Degree of Polymerization  Not Applicable  < 350
 pH  5 - 7.5  5 - 7
 Starch and Dextrins  Absent  Not Applicable
 Organic Impurities  Comply  Not Applicable
 Organic Volatile Impurities  Not Applicable  Comply
 Water Soluble Substances, %NMT  0.2  0.24
 Ether Soluble Substances, % NMT  Not Applicable  0.05
 Arsenic, PPM, NMT  2  Not Applicable
 Heavy Metal, PPM, NMT  10  10
 Residue on Ignition, % NMT  0.2  0.05
 Loss on Drying, % NMT  6  6
 Assay, %  97 - 102  Not Applicable
 Conductivity, µS / cm,not exceed than water by  Not Applicable  75
 Microbiology Analysis
 Total Aerobic Microbial Count, CFU/g, NMT  1000  1000
 Total Yeast and Mold Count, CFU/g, NMT  100  100
 Pseudomonas aeruginosa,per 10 g  Absent  Absent
 Escherichia coli, per 10 g  Absent  Absent
 Staphylococcus aureus, per 10 g  Absent  Absent
 Salmonella sp. per 10 g  Absent  Absent
 Inhouse Specifications
 Screen Analysis % Retention
 60 Mesh, NMT
 8
 200 Mesh, NLT
 45
 Bulk Density, g/cc
 0.28 - 0.50
    

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