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Kalmegh Extract


PRODUCT SPECIFICATION

QUALITY CONTROL DEPARTMENT
Product Name Andrographis Extract 20%
Botanical Name Andrographis Paniculata
Plant part Leaves
Standardization Andrographolide
S. No. Parameters Specification Method
Physical
1 Description Light Brown to Pale Green color powder with bitter taste Visual /Organoleptic
2 Identification To comply by HPLC KVN/QC/STP-IN/027
3 Loss on drying NMT 5.0% USP <731>
4 Residue on Ignition NMT 5.0% USP <281>
5 Tapped Bulk density 0.40 -0.80g/ml USP <616>
Sieve test (passes through)
6
# 40 mesh NLT 95.0%w/w
# 60 mesh NLT 90.0%w/w
USP <786>
Chemical
7 Assay By HPLC
Content of Andrographolide

NLT 20.0% w/w on dry basis

KVN/QC/STP- IN/027
Others
8
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
9 Residual solvents Should comply by ICH/USP USP <467>
Microbiological Profile
10
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>