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Bioprex Labs Pune, Maharashtra
| No | Tests | Limits | Protocol |
| 1 | Description | Light yellow brown powder | |
| 2 | Identification | To pass the test | TLC (Thin Layer Chromatography) |
| 3 | Physicochemical analysis | ||
| Mositure Content (% w/w) | < 5.0 | As per USP 24<561> Vegetable Drugs pg. 1885. Pg.2005 | |
| Ash content (%W/W) | < 8.0 | ||
| Acid insoluble ash (%w/w) | < 5.0 | ||
| pH of 5%w/v solution | 4.0 – 6.5 | As per USP<791> pg.1977 | |
| 4 | Heavy metals | ||
| Lead | <1ppm | AOAC/AAS | |
| Cadmium | <1ppm | AOAC/AAS | |
| Arsenic | <2ppm | AOAC/AAS | |
| Mercury | <0.1ppm | AOAC/AAS | |
| 5 | Microbiological analysis | ||
| Total viable aerobic count | <104 cfu g-1 | As per WHO/PHARMA/92.559/Rev.1/pg.4952 | |
| Total enterobacteriaceae | <102 cfu g-1 | ||
| Total fungal count | <102 cfu g-1 | ||
| E.Coli | Absent | IS:5887 (Part I): 1976 | |
| Salmonella sp. | Absent | IS: 15187:2002 | |
| S.aureus | Absent | IS: 5887(Part II): 1976 | |
| 6 | Aflatoxins (B1, B2, G1, G2) | < 5 ppb | AOAC Chap 49/HPLC |
| 7 | Pesticides residue analysis as per USP and BP limits | ||
| Organochlorine pesticides | To comply with USP | AOAC Chap.10/GC/ECD/USP 24 | |
| Organophosphorous pesticides | |||
| Organosulpher | IS: 138321993 | ||
| 8 | Phytochemical analysis | ||
| Total Withanolides (%w/w) | > 5 %w/w | By Gravimetry | |
We will contact you soon !
Tushar Jain
(Manager)
Bioprex Labs
Sadashiv Peth, Pune,
Maharashtra,
India
