| PRODUCT NAME |
CHLORTETRACYCLINE HCL |
| SPECIFICATIONS |
EP8.0 |
| TESTS |
SPECIFICATIONS |
RESULTS |
| Appearance |
Yellow powder |
Conforms |
| Identification |
| A ( Current Ph. Eur. 2.2.27) |
Thin·Layer Chromatography |
Positive |
| B(Current Ph. Eur. 0173) |
The colour becomes brownish |
Positive |
| C(Current Ph. Eur. 2.3.1) |
It gives reaction (a) of chlorides |
Positive |
| D(Current Ph. Eur. 2.2.29) |
Liquid chromatography |
Positive |
| pH (Current Ph. Eur. 2.2.3 |
2.3-3.3 |
2.69 |
| Specific Optica Irotation (CurrentPh.Eur.2.2.7) |
250° to 235°(anhydrous substance) |
249° |
| Absorbance (Current Ph. Eur. 2.2.25) |
≤0.40, 460nm |
0.202 |
| Related substances (Current Ph. Eur. 2.2.29) |
| Impurity A (4-epichlortetracycline) |
≤4.0% |
0.82% |
| Impurities E(4-epidemethylchlortetracycline) |
≤1.0% |
0.65% |
| Impurity J (anhydrotetracycline) |
≤0.3% |
0.08% |
| Impurities D(4-epitetracycline) |
≤0.2% |
<0.05%< td=""> |
| Impurities G(isochlortetracycline) |
≤0.2% |
Not detected |
Impurities H(2-acetyl-2
-decarboxamidochlortetracycline) |
≤0.2% |
0.12% |
| Impurities L(anhydrochlortetracycline) |
≤0.2% |
0.11% |
| Impurities K(4-epianhydrochlortetracycline) |
≤0.15% |
Not detected |
| Unspecified impurities |
| Impurities C(4-epidemethyltetracycline) |
≤0.10%
|
Not detected |
| Impurities F(4-epiisochlortetracycline) |
≤0.10% |
Not detected |
| Impurities I (4-epianhydrotetracycline) |
≤0.10% |
Not detected |
| Disregard limit (Other Unknown) |
≤0.05% |
Conforms |
| Sum of impurities other than A |
≤2.0% |
1.12% |
| Heavy metals (Current Ph. Eur. 2.4.8) |
≤50ppm |
<50ppm< td=""> |
| Water (Current Ph. Eur. 2.5.12) |
≤2.0% |
0.54% |
| Sulfated ash (Current Ph. Eur. 2.4.14) |
≤0.5% |
0.14% |
| ASSAY (Current Ph. Eur. 2.2.29) |
| Chlortetracycline hydrochloride (CTC.HCI) |
≤89.5% (anhydrous substance) |
91.76% |
| Tetracycline hydrochloride (TC.HCI) |
≤6.0% (anhydrous substance) |
5.86% |
| CTC.HCI+TC.HCI |
94.5-102,0%(anhydrous substance) |
97.62% |
| Ethanol (SOP) |
≤0.5%(GC) |
0.41% |
Pharma Sources Insight June 2024: Globalization on the Go
