Specification No. X04
N-(2,6-Dimethylphenyl)-5,6-dihydro-4H-1,3-thiazin-2-amine

Molecular Formula: C12H16N2S
Molecular Weight: 220.34
C.A.S. No.: [7361-61-7]
Description: White to near white powder.
| Tests: | |
| Identification: a) HPLC b) TLC |
|
| Absorbance of 2 % (w/v) aqueous solution measured in 1 cm cell at 400 nm: | max. 0.05 % |
| Heavy metals: | max. 0.001 % |
| Iron: |
max. 0.001 % |
| Chloride: | max. 0.1 % |
| Water (K.F. titration): |
max. 0.5 % |
| Sulphated ash: |
max. 0.2 % |
| Assay (HPLC): | min. 99.0 % Area |
| Assay (Acidimetric titration, calculation based on dry substance): | 98.0 - 102.0 % |
| Microbiological test: | Ph. Eur. 5 th Ed., <5.1.4> |
| Bacteria | max. 10 000 cfu/g |
| Fungi | max. 100 cfu/g |
| Enterobacteria | max. 100 cfu/g |
| Escherichia coli in 1g | absent |
| Salmonella in 10 g | absent |
| Pseudomonas aeruginosa in 1g | absent |
| Staphylococcus aureus in 1g | absent |
| Shelf life: 1 year | |