About usAbout usQuality ControlContact usFeedbackNetwork

PHARMACOPEIAL SPECIFICATIONS

Parameters MICROCRYSTALLINE CELLULOSE POWDERED CELLULOSE
IP BP USP26-NF21 JP BP USP-26NF21
Appearance
Fine or granular, white or almost white powder White or practically white, fine or granular powder White crystalline powder having fluidity White or practically white, fine or granular powder
Identification
A
Comply
Comply
Comply
Comply
Comply
Comply
B+C Comply - - Comply Comply Comply
B Degree of Polymerization
Not Applicable < 350 < 350 < 350 Not Applicable Not Applicable
Solubility in Ammoniacal Solution of Copper Tetramine
Not Applicable Soluble Not Applicable Not Applicable Soluble Not Applicable
pH
5 - 7.5
5 - 7.5
5 - 7
5 - 7
5 - 7.5
5 - 7.5
Starch and Dextrins
Absent
Absent
Not Applicable Not Applicable Absent
Not Applicable
Organic Impurities
Comply
Comply
Not Applicable Not Applicable Comply
Not Applicable
Organic Volatile Impurities
Not Applicable Not Applicable Comply Not Applicable Not Applicable Comply
Water Soluble Substances, %NMT
0.2
0.25
0.24
0.24
1
1.5
Ether Soluble Substances, % NMT
Not Applicable 0.05
0.05
0.05
0.15
0.15
Arsenic, PPM, NMT
2
Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable
Heavy Metal, PPM, NMT
10
10
10
10
10
10
Residue on Ignition, % NMT
0.2
0.1
0.05
0.05
0.3
0.3
Loss on Drying, % NMT
6 6 7 7 6 6
Assay, %
97 - 102
Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable
Conductivity, µS / cm,Not Exceed Than Water by
Not Applicable Not Applicable 75 75 Not Applicable Not Applicable
Microbiology Analysis
Total Aerobic Microbial Count, CFU/g, NMT
Not Applicable 1000
1000
1000
Not Applicable 1000
Total Yeast and Mold Count, CFU/g, NMT
Not Applicable 100 100 100 Not Applicable 100
Pseudomonas aeruginosa,per 10 g
Not Applicable Absent
Absent
Absent
Not Applicable Absent
Escherichia coli, per 10 g
Not Applicable Absent
Absent
Absent
Not Applicable Absent
Staphylococcus aureus, per 10 g
Not Applicable Absent Absent Absent Not Applicable Absent
Salmonella sp. Per 10 g
Not Applicable Absent Absent Absent Not Applicable Absent

Back