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Table 1 Certificate of Analysis

From: A comprehensive platform for quality control of botanical drugs (PhytomicsQC): a case study of Huangqin Tang (HQT) and PHY906

Test item

Specification

Result

General description

The product is a brown-colored powder possessing a little sweet taste

Passed

Identification

Identify Rf value and absorb spots of TLC to reference standards

Passed

Loss on drying

Not more than 10.0%

Passed

Water-soluble extractive

Not less than 60.0%

Passed

Dilute alcohol-soluble extractive

Not less than 60.0%

Passed

Total ash

Not more than 8.0%

Passed

Acid-insoluble ash

Not more than 2.0%

Passed

Limit tests

  

   Heavy metals (total)

Not more than 50 ppm

Passed

   Copper (Cu)

Not more than 50 ppm

Passed

   Arsenic (As)

Not more than 5 ppm

Passed

   Cadmium (Cd)

Not more than 2 ppm

Passed

   Mercury (Hg)

Not more than 0.5 ppm

Passed

   Lead (Pb)

Not more than 20 ppm

Passed

Microbial tests

  

   A. Bacteria count (colonies/g)

A. Not more than 10000/g

Passed

   B. Samonella species and Escherichia. coli

B. Negative

Negative

Identification

1) Identify HLPC chromatogram retention time match to reference standards

Passed

 

2) Marker 1 > 50.0 mg/g

Passed

 

   Marker 2 > 7.0 mg/g

Passed

 

   Marker 3 >5.3 mg/g

Passed

Pesticide residues

Total BHC's: Not more than 0.2 ppm

Not detected

 

Total DDT's: Not more than 0.2 ppm

Not detected

 

PCNB: Not more than 0.2 ppm

Not detected

  1. A typical Certificate of Analysis was supplied by the manufacturer of PHY906. Although these conventional tests provide specifications for botanical identification, general extraction information, specific heavy metals, microbial contamination, pesticide contamination and specific marker compounds, it does not provide a comprehensive chemical and biological profile of the extract for the purposes of quality control.