SPECIFICATION OF BIOPERINE

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

 

Specification