Pepe, estratto (Bioperine®)

Piper nigrum

Specificazione

Product NameBioperine® 95% dry extractRevised 4/2019
Product Code10083
Shelf life5 years
Storage conditionsCool and dry place, keep away from strong light and heat
Botanical namePiper nigrum
Part usedFruits (cultivated)
Preparation typeExtraction
Solvent usedEthanol
Extract Ratio50:1
StandardizationPiperine
Excipients /PreservativesNone
Country of originIndia
 
ParameterSpecificationMethod
DescriptionOff white to slight yellow powder with characteristic odourVisual
IdentificationTo comply by HPLCHPLC, SLL/STP-P-007**
SolubilitySoluble in alcohol and in glacial acetic acid; insoluble in waterUSP
Loss on drying≤ 2.0 % w/w (dried at 105°C)USP<731>
Residue on ignition≤ 0.1 % w/wUSP<281>
Melting range126°C to 132°CUSP<741>
Tapped bulk density0.55 g/ml to 0.85 g/mlUSP<616>
Loose bulk density0.30 g/ml to 0.65 g/mlUSP<616>
Sieve test≥ 95 % through 80 mesh
Assay: Piperine by HPLC95.0 % to 102.0 % w/w on dry basisHPLC, SLL/STP-P-007**
Total heavy metals≤ 10 ppmUSP<231>Method II
Lead≤ 3 ppmICP-OES, SLL/STP-H-006**
Arsenic≤ 1 ppmICP-OES, SLL/STP-H-006**
Cadmium≤ 1 ppmICP-OES, SLL/STP-H-006**
Mercury≤ 0.1 ppmICP-OES, SLL/STP-H-006**
Residual solventsto comply as per ICH/USPICH guidelines and USP
Residual pesticidesto comply as per USPUSP <561>
 
Microbiology
Total plate count≤ 3000 cfu/gUSP <2021>
Yeasts & Moulds≤ 100 cfu/g
E. coliNegative/10 g
SalmonellaNegative /10 g

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