| Customization: | Available |
|---|---|
| Certification: | ISO, FDA, HACCP, GMP |
| Assay Method: | HPLC, UV |
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| 1. | Appearance | Amorphous Powder | |
| 2. | Colour | Yellow to Yellowish-Brown | |
| 3. | Odour | Slight, Specific | |
| 4. | Solubility | ||
| - in Water | Practically Insoluble | ||
| - in Methanol and Acetone | Soluble | ||
| 5. | Identification | ||
| - TLC | To Comply with The Test | ||
| - HPLC | To Comply with The Test | ||
| 6. | Sulphated Ash | NMT 0.6% | |
| 7. | Heavy metals | NMT 10 PPM | |
| - Arsenic - Atomic Absorption | NMT 0.1 PPM | ||
| - Cadmium - Atomic Absorption | NMT 0.1 PPM | ||
| - Lead - Atomic Absorption | NMT 0.1 PPM | ||
| - Mercury - Atomic Absorption | NMT 0.1 PPM | ||
| 8. | Loss On Drying (2 Hours 105 ºC) | NMT 5.0% | |
| 9. | Powder size | 80Mesh, NLT90% | |
| 10. | Assay of Silymarin (UV test, per cent) | Min. 80 | |
| 11. | Assay of Silymarin (HPLC, determined as silybin, per cent) | From 40,0 to 80,0 | |
| - sum of silycristine and silydianine (HPLC, per cent of the total content of silymarine) |
From 20,0 to 45,0 | ||
| - sum of silybin А and silybin В (HPLC, per cent of the total content of silymarine) |
From 40,0 to 65,0 | ||
| - sum of isosilybin А and isosilybin В (HPLC, per cent of the total content of silymarine) |
From 10,0 to 20,0 | ||
| 12. | Residual Solvents | ||
| - Ethyl Acetate | NMT 5000 PPM | ||
| - Acetone | NMT 5000 PPM | ||
| - Methanol | NMT 3000 PPM | ||
| - Ethanol | NMT 5000 PPM | ||
| -N-hexane | NMT 290 PPM | ||
| 13. | Residual Agrichemicals | ||
| - Total BHC (Sum of α,β,γandδ-BHC) | NMT 0.2 PPM | ||
| - Total DDT (Sum of p,p'-DDD,P,P'-DDE,o,p'-DDT and p,p' -DDT) | NMT 0.1 PPM | ||
| - Aldrin | NMT 0.1 PPM | ||
| - Endrin | NMT 0.1 PPM | ||
| - Dieldrin | NMT 0.1 PPM | ||
| 14. | Microbiological Quality (Total viable aerobic count) | ||
| - bacteria, CFU/g, not more than | 103 | ||
| - moulds and yeasts, CFU/g, not more than | 102 | ||
| E.coli, Salmonella, S. aureus, CFU/g | Inadmissible | ||
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