GSE - 011 Specification

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SPECIFICATION

GYMNEMA SYLVESTRE EXTRACT

Product name : Gymnema sylvestre extract Product code : GSE- 011


Latin Name : Gymnema sylvestre Country of Origin : India
Harvest Type : Cultivated Plant Part Used : Leaves
Description Specification Method
Physical Characteristic
Colour Pale green to brown Visual
Appearance Powder (hygroscopic) Visual
Flavour Characteristic Organoleptic
Odour Characteristic Organoleptic
Analytical Assay
Herb extract Ratio 5:1 In House Specification
Solubility (in water) Soluble IP
Moisture NMT 5% USP 37<921>
Extraction solvent 100% Alcohol In House Specification
Alcohol NMT 5000 ppm USP<467>
Tap density(Gm/ml) >0.40 USP 37<616>
Bulk density(Gm/ml) >0.25 USP 37<616>
Partilce Size 100% thru 30 # USP 37<786>
Pesticide Residue Complies with USP USP 37<561>
Excepients None In House Specification
Carriers None In House Specification
Additives used None In House Specification
Trace Metals
Heavy Metals NMT 10 ppm ICP-MS
Lead NMT 3 ppm ICP-MS
Arsenic NMT 1 ppm ICP-MS
Mercury NMT 0.1 ppm ICP-MS
Cadmium NMT 1 ppm ICP-MS
Microbial Assay
Total Plate Count NMT 10,000 cfu/g AOAC BAM
Yeast & Mould NMT 1000 cfu/g AOAC,BAM
Salmonella Absent/25 g AOAC,BAM
E.coli Absent/10 g AOAC,BAM
Coliforms Absent / 10 g AOAC,BAM
Assay of Actives
Gymnemic acid content Minimum 25% Gravimetric method

Packing 25kg HM-HDPE container with polythene inner lining


Storage Keep in air tight containers and in inert atmosphere at ambient temperature
Shelf life 24 months

Note: Since it is an herbal product, there is likely to be minor colour variation from batch to batch because of
the seasonal variations of the raw materials. Colour change will not affect the quality and efficacy of the product

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GSE-011 Doc ID:QCS-18a, Rev No:09/01, Rev date:27/05/2014

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