Customization: | Available |
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Certification: | ISO, FDA, HACCP, GMP |
Assay Method: | HPLC, UV |
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Audited by an independent third-party inspection agency
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 |