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CERTIFICATE OF ANALYSIS

Product Name : Labisia pumila DE 15


Indonesian Name : Kacip Patimah
Product Code : 1L02E15
Batch Number : 071LU
Manufacturing Date : November 2019
Expired Date : November 2022

GENERAL DATA
Dosage Form : Liquid Extract
Plant Species : Labisia pumila
Parts Used : Folium
Excipient : Lactose, Aerosil
Extraction Solvent : Ethanol – Water
Native Extract Content : 15%

PHYSICALS – CHEMICALS DATA


ITEM STANDARD RESULT METHOD
Appearance Brown white characteristic Conform Internal Method
odor,and characteristic taste
Water content Maximum 10% 8.99% FI-V
Solubility Partly soluble in water Conform Interal Method
Total ash Maximium 10% 5.10% FI-V
Residual solvent Maximum 0.5% Conform USP 37
Heavy Metal
- Pb ≤ 10 mg/kg Conform USP 37
- Cd ≤ 0.3 mg/kg Conform USP 37
- As ≤ 5 mg/kg Conform USP 37
- Hg ≤ 0.5 mg/kg Conform USP 37

MICROBIOLOGICAL DATA
ITEM STANDARD RESULT METHOD
Total Aerobic Bacteria Maximum 104 cfu/g ˂ 10 cfu/g USP 37
Fungi Maximum 103 cfu/g ˂ 10 cfu/g USP 37
Escherichia coli Negative Negative USP 37
Stahpylococcus aureus Negative Negative USP 37
Salmonella sp. Negative Negative USP 37
Pseudomonas aerugenosa Negative Negative USP 37

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