| Special characteristics: |
| Color: Not higher than Y-7 / EP |
| Particle size distribution: |
| Less than 90 µm: |
min 80% |
| Less than 40 µm: |
50 - 80% |
| Less than 26 µm: |
25 - 50% |
| Polymorphism: |
Minimum 95% a
crystalline form |
| Shelf life: 36 months |
| EDMF 2001-052 (Agence Française
de Securite Sanitaire des Produits de Sante) |
| EDMF EMEA/H/C/478 (European
Agency for the Evaluation of Medicinal Products under Centralized
Procedure) |
| EDMF EMEA/H/C/467 (European
Agency for the Evaluation of Medicinal Products under Centralized
Procedure) |
| |
conforms to:
U.S. Pharmacopoeia
|
1. Description
White to almost white powder, practically odorless, and free
of foreign matter. |
| 2. Identity |
| Infrared Spectrum |
Comparable to the reference |
3. Water (K.F.
Coulometric)
Not more than 0.50% |
4. Assay (HPLC)
98.0% to 101.5% (on the dried basis) |
| 5. Impurities
(HPLC): |
| Individual Impurity: |
Not more than 0.10% |
| Total Impurities: |
Not more than 0.30% |
6. Ordinary
Impurities (TLC)
Not more than 0.1% |
7. Heavy Metals
Maximum 0.002% |
| 8. Residual
Solvents (G.C. / H. Space): |
| Ethanol: |
Not more than 0.05% (500ppm) |
| N’-N Dimethylformamide: |
Not more than 0.05% (500ppm) |
| Xylenes: |
Not more than 0.05% (500ppm) |
| Ethyl Acetate: |
Not more than 0.05% (500ppm) |
| 9. Microbiological
Test |
| Total Aerobic Count: |
Not more than 100CFU/g |
| Escherichia coli: |
Absent |
10. Organic
Volatile Impurities
Excluded by the manufacture process |
