Specification No. C02
Clopamide
4-chloro-N-(cis-2,6-dimethylpiperidino)-3-sulfamoylbenzamide
Molecular Formula: C14H20ClNO3O3S
Molecular Weight: 345.85
C.A.S. No.: [636-54-4] Merk 12: 2454
Description: White or slightly yellow powder.
| Tests: | Limit: | Methods: |
| Identification: TLC | NQ C 02, test No. 1 | |
| Clarity of 2.5 % solution in methanol: | clear | Ph. Eur. 5th Ed., <2.2.1> |
| Color of 2.5 % solution in methanol: | max. Y 6 | Ph. Eur. 5th Ed., <2.2.2> |
| Any individual impurity (TLC): | max. 1.0 % | NQ C 02, test No. 4 |
| Heavy metals: | max. 0.001 % | Ph. Eur. 5th Ed., <2.4.8> |
| Iron: |
max. 0.001 % | NQ C 02, test No. 5 |
| Sulphated ash: |
max. 0.20 % | Ph. Eur. 5th Ed., <2.4.14> |
| Loss on drying (105 °C): | max. 2.5 % | Ph. Eur. 5th Ed., <2.2.32> |
| Assay (Acidimetry, calculation based on dry substance): |
98.0 - 102.0 % | NQ C 02, test No. 9 |
| Methanol (GC): | max. 2500 ppm | NQ C 02, test No. 10 |
| Ethanol (GC): | max. 2500 ppm | NQ C 02, test No. 11 |
| Ethyl acetate (GC): | max. 2500 ppm | NQ C 02, test No. 12 |
| Microbiological test: | Ph. Eur. 5th Ed., <5.1.4> | |
| Bacteria: | max.1000 cfu/g | |
| Fungi: | max.100 cfu/g | |
| Escherichia coli in 1 g | absent | |
| Shelf life: 2 years | ||
*NQ = Norm of Quality
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