Spécification
| Product Name | Bioperine® 95% dry extract | Revised 4/2019 |
| Product Code | 10083 | |
| Shelf life | 5 years | |
| Storage conditions | Cool and dry place, keep away from strong light and heat | |
| Botanical name | Piper nigrum | |
| Part used | Fruits (cultivated) | |
| Preparation type | Extraction | |
| Solvent used | Ethanol | |
| Extract Ratio | 50:1 | |
| Standardization | Piperine | |
| Excipients /Preservatives | None | |
| Country of origin | India | |
| Parameter | Specification | Method |
| Description | Off white to slight yellow powder with characteristic odour | Visual |
| Identification | To comply by HPLC | HPLC, SLL/STP-P-007** |
| Solubility | Soluble in alcohol and in glacial acetic acid; insoluble in water | USP |
| Loss on drying | ≤ 2.0 % w/w (dried at 105°C) | USP<731> |
| Residue on ignition | ≤ 0.1 % w/w | USP<281> |
| Melting range | 126°C to 132°C | USP<741> |
| Tapped bulk density | 0.55 g/ml to 0.85 g/ml | USP<616> |
| Loose bulk density | 0.30 g/ml to 0.65 g/ml | USP<616> |
| Sieve test | ≥ 95 % through 80 mesh | |
| Assay: Piperine by HPLC | 95.0 % to 102.0 % w/w on dry basis | HPLC, SLL/STP-P-007** |
| Total heavy metals | ≤ 10 ppm | USP<231>Method II |
| Lead | ≤ 3 ppm | ICP-OES, SLL/STP-H-006** |
| Arsenic | ≤ 1 ppm | ICP-OES, SLL/STP-H-006** |
| Cadmium | ≤ 1 ppm | ICP-OES, SLL/STP-H-006** |
| Mercury | ≤ 0.1 ppm | ICP-OES, SLL/STP-H-006** |
| Residual solvents | to comply as per ICH/USP | ICH guidelines and USP |
| Residual pesticides | to comply as per USP | USP <561> |
| Microbiology | ||
| Total plate count | ≤ 3000 cfu/g | USP <2021> |
| Yeasts & Moulds | ≤ 100 cfu/g | |
| E. coli | Negative/10 g | |
| Salmonella | Negative /10 g | |
| All information is non-binding, subject to change | ||