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 |
