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Gynema Extract


PRODUCT SPECIFICATION

QUALITY CONTROL DEPARTMENT
Product Name Gymnema Extract 75%
Botanical Name Gymnemasylvestre
Plant part Leaves
Standardization Gymnemic acids
S. No. Parameters Specification Method
Physical
1 Description Green to dark green powder with bitter taste Visual/ Organoleptic
2 Identification To comply by TCL KVN/QC/STP-TLC/003
3 Loss on drying NMT 6.0% w/w USP <731>
4 Water soluble extractives NLT 90.0% w/w KVN/QC/STP-GT/039
5 Alcohol soluble extractives NLT 50.0% w/w KVN/QC/STP-GT/026
6 Residue on Ignition NMT 5.0% USP <281>
7 Tapped bulk density 0.40 -0.70g/ml USP <616>
Sieve test (passes through)
8
# 40 mesh NLT 95.0%w/w
# 60 mesh NLT 90.0%w/w
USP <786>
Chemical
9 Assay By Gravimetry Content of Gymnemic acids
NLT 75.0% w/w on dry basis

KVN/QC/STP-GT/024
Others
10
Heavy Metals
Lead NMT 5.0ppm ICP-OES
Arsenic NMT 1.0ppm ICP-OES
Cadmium NMT 0.3ppm ICP-OES
Mercury NMT 0.1ppm ICP-OES
11 Residual solvents Should comply by ICH/USP USP <467>
Microbiological Profile
12
Total plate count NNMT 5000cfu/g USP <2021>
Yeast and molds count NMT 100cfu/g USP <2021>
Escherichia coli Absent /10g USP <2022>
Salmonella Absent /10g USP <2022>
Staphylococcus aureus Absent /10g USP <2022>
Pseudomonas aeruginosa Absent /10g USP <62>