Product specification
| Parameter | Specification |
|---|---|
| Characteristics | (3-[(2RS)-2-amino-2-phenylethyl]thiazolidin-2-one) Impurity B (3-[(E)-2-phenylethenyl]thiazolidin-2-imine) Impurity C ((4RS)-4-phenyl-1-(2-sulfanylethyl)imidazolidin-2-one) Impurity D (6-phenyl-2,3-dihydroimidazo[2,1-b]thiazole) Impurity E Any other impurity Total impurities HAZARDOUS IDENTIFICATION STORAGE White or almost white crystalline powder. Freely soluble in water, soluble in alcohol, slightly soluble in methylene chloride. 98.5% to 101.0% ( dried substance) Conforms to Ph. Eur. tests As per Ph. Eur. test: Solution S is clear and not more intensely coloured than reference solution Y7 3.0 to 4.5 -121 o to -128 o Not more than 20ppm Not more than 0.5% Not more than 0.1% |
| Assay (content) | Maximum 0.2% |
| Identification | Maximum 0.2% |
| Appearance Of Solution | Maximum 0.2% |
| pH | Maximum 0.2% |
| Specific optical rotation | Maximum 0.2% |
| Heavy metals | Maximum 0.1% |
| Loss on drying | Maximum 0.3% |
| Sulphated ash | Hazardous class 6.1, UN 2811, Packing group III |
| Impurity A | Keep container tightly closed in a cool and dry place and protected from light. Protect from contamination by foreign substances. |