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 |