Items | Specifications |
---|---|
1.Characters: | A white or almost white powder, slightly soluble in water, very slightly soluble in alcohol. It melts at about 225 °C, with decomposition. |
2.Identification | A. Infrared spectrum is march with the spectrum of allantoin CRS B. Thin-Layer Chromatographic Identification Test |
3. Assay | 98.5-101.0% |
Sulfated ash (EP/BP) | <0.1% |
5.Related substances (EP/BP) Organic impurities (USP) | Conform |
6. Acidity or alkalinity | To 5 mL of solution S add 5 mL of carbon dioxide-free water R,c 0.1 mL of methyl red solution R and 0.2 mL of 0.01 M sodium hydroxide. The solution is yellow. Add 0.4 mL of 0.01 M hydrochloric acid . The solution is red. |
7. Loss on drying | <0.1% |
8. Reducing substances | Shake 1.0 g with 10 mL of water R for 2 min. Filter. Add 1.5 mL of 0.02 M potassium permanganate. The solution must remain violet for at least 10 min. |
9. Optical rotation | -0.10º~+0.10º |
10. Heavy Metal | ≤10ppm |
11.Solution S | Dissolve 0.5 g in carbon dioxide-free water R, with heating if necessary, and dilute to 100 mL with the same solvent. |
12.Total Viable Count 霉菌和酵母菌计数 | <100CFU/G <100CFU/克 |