Specification No. D 03
Dithiaden
N,N-dimethyl-3-thienol[2,3-c][2]benzothiepin-4(9H)-ylidenepropylamine hydrochloride
Molecular Formula: C17H20ClNS2
Molecular Weight: 337.92
C.A.S. No.: [1154-12-7]
Description: White or slightly yellow powder.
| Tests: | Limits: | Methods: |
| Identification: a) Bisulepine b) Chloride c) UV spectrum |
NQ D03, test No. 1 NQ D03, test No. 2 NQ D03, test No. 3 |
|
| Clarity of 5 % aqueous solution: | clear or slightly turbid | Ph. Eur.5th Ed., <2.2.1> |
| Absorbance of 1% (w/v) aqueous solution measured in 1 cm cell at 400 nm: | max. 0.10 | NQ D03, test No. 5 |
| Heavy metals: | max. 0.001 % | Ph. Eur.5th Ed., <2.4.8> |
| Iron: | max. 0.001 % | NQ D03, test No. 7 |
| Sulphate: | max. 0.02 % | Ph. Eur.5th Ed., <2.4.13> |
| Cis-isomer (HPLC): | max. 2.0 % | NQ D03, test No. 9 |
| Loss on drying (105 ºC): | max. 0.5% | NQ D03, test No. 10 |
| Sulphated ash: |
max. 0.1 % | Ph. Eur.5th Ed., <2.4.14> |
| Assay (Acidimetric titration, calculation based on dry substance): |
99.0 - 100.5 % | NQ D03, test No. 12 |
| Acetone (GC): | max. 5000 ppm | NQ D03, test No. 13 |
| Benzene (GC): | max. 2 ppm | NQ D03, test No. 14 |
| Petroleum ether (GC): | max. 25 ppm | NQ D03, test No. 15 |
| Microbiological test: | Ph. Eur.5th Ed., <5.1.4> | |
| Total viable aerobic count | max. 100 cfu/g | |
| Total enterobacteria count | max. 10 cfu/g | |
| Pseudomonas aeruginosa in 1g | absent | |
| Staphylococcus aureus in 1g | absent | |
| Shelf life: 2 years | ||
*NQ = Norm of Quality
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