Specifications



Product name SILBINOL® (PTEROCARPUS EXTRACT 5%)
Product code 1695
Botanical/Scientific name Pterocarpus marsupium
CAS No 84604-08-0
Plant part Wood
Preparation type Extraction
Solvent used for extraction Methanol
Solvent used in manufacture DM water
Final extract ratio 7:1 to 9:1
Standardization Pterostilbene and Epicatechin
Excipient used Magnesium carbonate and Dextrin
Excipient Name %Used CAS No.
Magnesium carbonate 20% to 25% 546-93-0
Dextrin 30% to 35% 9004-53-9
Parameters Limit Reference
PHYSICAL    
Description Pale brown to brown powder with or without reddish tinge with characteristic odor* Organoleptic
Identification To comply by HPLC SLL/STP-P-013**
Solubility SLL/STP-S-028**
Water solubles (1% w/v solution in water) Not less than 15.0% w/w
Alcohol solubles (1% w/v solution in 95% v/v alcohol) Not less than 10.0% w/w
Loss on drying Not more than 5.0% w/w (dried at 105°C) USP <731>
Tapped bulk density Between 0.35g/ml and 0.65g/ml USP <616>
Loose bulk density Between 0.25g/ml and 0.50g/ml USP <616>
Sieve Test (Passes Through) USP <786>
20 Mesh Not less than 100% w/w
40 Mesh Not less than 85% w/w
80 Mesh Not less than 60% w/w
CHEMICAL
Assay
Content of Pterostilbene by HPLC Not less than 5.00% w/w and not more than 5.50% w/w on dry basis SLL/STP-P-013**
Content of Epicatechin by HPLC Not less than 0.01% w/w and not more than 1.00% w/w on dry basis SLL/STP-P-013**
OTHERS
Parameters Limit Reference
Total heavy metals Not more than 20ppm (μg/g) USP <231> Method II
Lead Not more than 3ppm (μg/g) ICP-OES, SLL/STP-H-006**
Arsenic Not more than 1ppm (μg/g) ICP-OES, SLL/STP-H-006**
Cadmium Not more than 1ppm (μg/g) ICP-OES, SLL/STP-H-006**
Mercury Not more than 0.1ppm (μg/g) ICP-OES, SLL/STP-H-006**
Residual solvents To comply as per USP USP <467>
Residual pesticides To comply as per USP USP <561>
MICROBIAL
Total plate count Not more than 5000cfu/g USP<2021>
Yeast and mould count Not more than 100cfu/g USP<2021>
Escherichia coli Negative/10g USP <2022>
Salmonella Negative/10g USP <2022>
Staphylococcus aureus Negative/10g USP <2022>
Pseudomonas aeruginosa Negative/10g USP <62>
Enterobacteriaceae Negative/10g USP<2021>
ADDITIONAL INFORMATION
Sanitizing treatment Non-irradiated and not treated with ETO
Certification status (Kosher/Halal) Kosher Certified , Halal Certified
Genetic Modification Status GMO free
BSE/TSE status BSE / TSE free
Country of origin India
Cultivated or wild crafted Cultivated
Storage condition Store at room temperature
Shelf Life 5 Year(s)
Manufactured by Sami Labs Limited
19/1,19/2 I Main, II Phase,Peenya Industrial Area,Bangalore - 560058,
Karnataka, India
 
*Since it is a herbal product, there is likely to be minor color variation because of the geographical and seasonal variations of the raw material
*Natural products can be hygroscopic and tend to agglomerate sometimes. It is suggested to sift before use.
**In-House developed and validated methods


Product name Pterocarpus Ext 90% (Silbinol)
Product code 1677
Category Intended for Nutraceutical application
Botanical/Scientific name Pterocarpus marsupium
CAS No Pterostilbene: 537-42-8 (trans)
Plant part Wood
Preparation type Extraction
Solvent used for extraction Methanol
Solvent used in manufacture Hexane, Ethyl acetate, Ethanol
Final extract ratio 200:1 to 225:1
Standardization Pterostilbene
Excipient used None
Parameters Limit Reference
PHYSICAL
Description Off white powder* Visual
Identification To comply by HPLC SLL/STP-P-011**
Solubility Soluble in alcohol, insoluble in water USP
Loss on drying Not more than 2.0% w/w (dried at 80°C, under vacuum) USP <731>
Tapped bulk density Between 0.4g/ml and 0.65g/ml USP <616>
Loose bulk density Between 0.2g/ml and 0.5g/ml USP <616>
Sieve Test (Passes Through) USP <786>
20mesh Not less than 100% w/w
40mesh Not less than 85% w/w
80mesh Not less than 70% w/w
CHEMICAL
Assay
Content of Pterostilbene by HPLC Not less than 90.0% w/w on dry basis SLL/STP-P-011**
OTHERS
Total heavy metals Not more than 20ppm (μg/g) USP <231> Method II
Lead Not more than 3ppm (μg/g) ICP-OES, SLL/STP-H-006**
Arsenic Not more than 1ppm (μg/g) ICP-OES, SLL/STP-H-006**
Cadmium Not more than 1ppm (μg/g) ICP-OES, SLL/STP-H-006**
Mercury Not more than 0.1ppm (μg/g) ICP-OES, SLL/STP-H-006**
Residual solvents To comply as per USP USP <467>
Residual pesticides To comply as per USP USP<561>
MICROBIAL
Parameters Limit Reference
Total aerobic microbial count Not more than 5000cfu/g USP <2021>
Total yeasts and molds count Not more than 100cfu/g USP <2021>
Escherichia coli Negative/10g USP <2022>
Salmonella Negative/10g USP <2022>
Staphylococcus aureus Negative/10g USP <2022>
Pseudomonas aeruginosa Negative/10g USP <62>
Bile tolerant gram negative bacteria Negative/10g USP <2021>
ADDITIONAL INFORMATION
Sanitizing treatment Non-irradiated and not treated with ETO
Certification status (Kosher/Halal) Kosher Certified
Genetic Modification Status GMO free
BSE/TSE status BSE / TSE free
Country of origin India
Cultivated or wild crafted Cultivated
Storage condition Store at room temperature
Shelf Life 5 Year(s)
Manufactured by Sami Labs Limited
19/1,19/2 I Main, II Phase,Peenya Industrial Area,Bangalore - 560058,
Karnataka, India
 
*Since it is a herbal product, there is likely to be minor color variation because of the geographical and seasonal variations of the raw material
*Natural products can be hygroscopic and tend to agglomerate sometimes. It is suggested to sift before use.
**In-House developed and validated methods