|
MicroCrystalline Cellulose Powder (Spray Dried) Direct Compressible Grade |
|
Type- PH-101 |
| Identification : U S P XXIII |
| Properties : |
| Physical Classification :
White Powder, Non- fibrous Appearance : Crystalline, Tasteless, Odourless, free flowing |
|
Results with Protocols of Tests Applied |
|
| Name of Test | Batch Analysis Results |
|
Appearance @ 25 C |
Wh/crea powder |
| Identification Test (A & B) | Meets Requirements |
| Identification Test (C) DOP | Meets Requirements |
| Conductivity us | 36.3 us |
| pH | 6.2 |
| % Loss on Drying | 1.6 % |
| % Residue on ignition | 0.01 % |
| % Water soluble substances | 0.1 % |
| % Ether soluble substances | 0.02 % |
| ppm Heavy metals | LT 10 ppm |
| Bulk Density (g / cm3) | 0.31 g / cm3 |
| % Cellulose | 97% |
|
Microbiological Tests |
Results |
| Total aerobic plate count / g | Meets Requirements |
| Mould / yeast CFU / g | Meets Requirements |
| Staphylococcus Aureus CFU / g | Negative |
| Salmonella CFU / g | Negative |
| Pseudomonas Aeruginosa CFU / g | Negative |
| E.Coli CFU / g | Negative |
|
Additional Dipchem Standards |
|||
| a) % on 60 mesh |
PH - 101 |
NMT 1.0 % |
0.3 % |
|
PH - 102 |
NMT 8.0 % |
||
| b) % on 200 mesh |
PH - 101 |
NMT 30 % |
17.6 % |
|
PH - 102 |
NLT 45 % |
||
|