|
CERTIFICATE OF ANALYSIS |
|
CHEMICEL - PH-302 |
| COMPENDIA STANDARDS | SPECIFICATIONS | BATCH ANALYSIS |
| Loss on Drying % | 6 Max | 2.2 |
| Identification Test ( A & B) | Pass | Pass |
| pH | 5.0 - 7.0 | 6.1 |
| Residue on Ignition % | 0.1 | 0.03 |
| Water soluble Substance % | 0.2 | 0.12 |
| Ether soluble substance % | 0.05 | 0.04 |
| Organic Impurities | Pass | Pass |
| Solubility ( in ammonical sol. of Cu. tetramine ) | Soluble | Soluble |
| Heavy metals, ppm | 10 max | < 10 |
| Starch | Negative | Pass |
|
CHEMICEL STANDARDS |
||
| Air jet particle size, wt % + 60 mesh (250 micron) | 8 max | 0.2 |
| Air jet particle size, wt % + 200 mesh (74 micron) | 45 min | 61 |
| Bulk Density (g/cm3) | 0.32 - 0.36 | 0.33 |
| Cellulose % | 97 - 102 | 97 |
| Identification Test ( D & E)* | Pass | Pass |
| Arsenic, ppm * | 2 max | < 2 |
| Conductivity ms** | 75 ms max | 56 |
|
MICROBIOLOGICAL SPECIFICATION |
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| Total Aerobic Microbial Count, CUF / g | NMT 200 | < 100 |
| Mould / Yeast, CUF / g | NMT 50 | < 20 |
| Staphylococcus | Absent | Absent |
| Salmonella, CFU/g | Absent | Absent |
| Pseudomonas Aeruginosa CFU/g | Absent | Absent |
| E. Coli, CFU/g | Absent | Absent |
| * - Where analysis is performed as per Indian Pharmacopoeia |
| ** - Where analysis is performed as per United States Pharmacopoeia |