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Planta Med 2022; 88(12): 1004-1019
DOI: 10.1055/a-1478-9143
Biological and Pharmacological Activity
Original Papers

Development and Validation of a Species-specific PCR Method for the Identification of Ginseng Species Using Orthogonal Approaches

Zhengfei Lu 
1   United States Pharmacopeia (USP) Project Team on Botanical Library for Identification using DNA-based Methods, Rockville, MD, USA
5   Herbalife International of America, Inc., Corporate Center of Excellence Quality Laboratory, Torrance, CA, USA
,
Sara M. Handy 
2   Center for Food Safety and Applied Nutrition, Office of Regulatory Science, U. S. Food and Drug Administration, College Park, MD, USA
,
Ning Zhang
3   United States Pharmacopeia (USP), Rockville, MD, USA
4   Currently at TopEdit Author Services, Gaithersburg, MD, USA
,
Zheng Quan
1   United States Pharmacopeia (USP) Project Team on Botanical Library for Identification using DNA-based Methods, Rockville, MD, USA
5   Herbalife International of America, Inc., Corporate Center of Excellence Quality Laboratory, Torrance, CA, USA
,
Qun Xu
3   United States Pharmacopeia (USP), Rockville, MD, USA
,
Michael Ambrose
3   United States Pharmacopeia (USP), Rockville, MD, USA
,
Gabriel Giancaspro
3   United States Pharmacopeia (USP), Rockville, MD, USA
,
Nandakumara D. Sarma
3   United States Pharmacopeia (USP), Rockville, MD, USA
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Abstract

When testing botanical ingredients of herbal medicines and dietary supplements, the complexity of botanical matrixes often requires the use of orthogonal methods to establish identification procedures suitable for quality control purposes. Genomic-based botanical identification methods are evolving and emerging as useful quality control tools to complement traditional morphological and chemical identification methods. Species-specific polymerase chain reaction methods are being evaluated for botanical quality control and as a cost-effective approach to identify and discriminate between closely related botanical species. This paper describes orthogonal identification of Panax ginseng, P. quinquefolius, and P. notoginseng materials in commerce as an example of the development and validation of a set of species-specific polymerase chain reaction methods to establish botanical identity in ginseng roots. This work also explored the possibility of extending the application of species-specific polymerase chain reaction methods to provide species identity information for processed materials, such as steamed roots and hydroalcoholic extracts, and showed success with this approach. Finally, the paper provides recommendations for an out-of-specification investigation of samples that may pass some of the orthogonal tests and fail others.

Key words

Panax spp. - Araliaceae - species-specific PCR - DNA-based identification - orthogonal tests - botanical dietary supplements

Supporting Information

    The specificity assessment of P. ginseng-, P. quinquefolius-, and P. notoginseng-specific PCR primers (Fig. 1S), HPTLC chromatogram (Fig. 2S–5S), and HPLC chromatogram (Fig. 6S–8S) of ginseng root samples are available as supporting figures. The list of target and nontarget BRMs used in the specificity study (Table 1S) and FDA-CFSAN Lab PCR results (Table 2S) are available as supporting tables.

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Publication History

Received: 02 April 2021

Accepted after revision: 20 July 2021

Article published online:
13 August 2021

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