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GB/T 43809-2024: Technical requirements for establishing characteristic spectra of plant extracts feed addditives
GB/T 43809-2024
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 65.120
CCS B 46
Technical requirements for establishing characteristic
spectra of plant extracts feed additives
ISSUED ON: MARCH 15, 2024
IMPLEMENTED ON: OCTOBER 01, 2024
Issued by: State Administration for Market Regulation;
National Standardization Administration.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Technical requirements ... 6
Appendix A (Informative) Application of characteristic spectra ... 12
Appendix B (Informative) Characteristic spectra report example - Characteristic spectra
of licorice extract ... 13
References ... 16
Technical requirements for establishing characteristic
spectra of plant extracts feed additives
1 Scope
This document defines the terms and definitions of the characteristic spectra of plant
extract feed additives, specifies the technical requirements for the formulation of
characteristic spectra.
This document is applicable to the formulation of characteristic spectra of plant extract
feed additives, by high performance liquid chromatography and gas chromatography.
2 Normative references
This document has no normative references.
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Plant extracts feed additives
Use specific parts or whole plants of a single plant as raw materials, through
extraction and (or) separation and purification processes, to acquire targeted and
concentrate one or more components in the plant, which generally does not change
the structural characteristics of the original components of the plant; a small amount
or trace amount of substances are added during feed processing, production, use.
Note 1: Include purified extracts, component extracts, simple extracts.
Note 2: The product form is solid, liquid or paste.
3.2
Purified extracts
Single-component products obtained from plants through extraction, separation,
purification.
retention time of the characteristic peak in the characteristic spectra.
4 Technical requirements
4.1 Establishment of characteristic spectra
4.1.1 General requirements
The establishment of characteristic spectra shall include requirements such as source,
selection of determination method, preparation of specimen solution, preparation of
reference solution, chromatographic conditions and system suitability test, verification
of analytical method, determination, characteristic spectra, technical parameters.
4.1.2 Source
Include the origin of plant raw materials, the parts used, the preparation process of plant
extracts.
The plant extracts for the development of characteristic spectra shall be of reliable and
representative sources and meet the following requirements:
a) The number of sample batches shall not be less than 15;
b) Products of the same specifications as produced continuously by the same raw
materials, using the same process or the same batch shall be considered as one
batch;
c) Plant extract raw materials shall generally cover the compliant varieties, origins,
harvesting time, primary processing methods of the source plants;
d) For plant extract feed additives developed based on plant raw materials from
specific sources, the raw material sources shall cover the specific varieties,
origins, harvesting time, parts, primary processing methods of the source plants.
4.1.3 Selection of determination method
According to the physicochemical properties of the chemical components contained in
plant extract feed additives, select high performance liquid chromatography or gas
chromatography.
4.1.4 Preparation of specimen solution
Establish dissolution and extraction methods according to the physicochemical
properties of the components contained in the specimen. The main influencing factors,
including the type and amount of solvent, extraction method and temperature, shall be
investigated to determine the appropriate preparation method, to ensure that the main
components and characteristic components in the specimen are transferred to the
solution. If necessary, other treatment methods such as hydrolysis and derivatization
can be added.
4.1.5 Preparation of reference substance solution
A reference substance shall be set up for the formulation of characteristic spectra.
Generally, one or more easily accessible main effective ingredients, unique ingredients,
secondary effective ingredients or main labeled ingredients are selected as reference
substances; if necessary, the reference substance of the characteristic peak of the trace
component other than the main effective ingredient can be selected as a reference
substance for the purified extract.
According to the composition of the plant extract, select an appropriate reference as a
reference substance; write down the name, CAS number, purity of the reference
substance. Accurately weigh an appropriate amount of the reference substance and
prepare a solution of a certain concentration with an appropriate solvent.
4.1.6 Chromatographic conditions and system suitability test
4.1.6.1 Determination of chromatographic conditions
Within the appropriate time range, the chromatogram shall obtain as many
chromatographic peaks as possible, to ensure that the main components are well
separated by chromatography and meet the principle of maximizing effective
information.
High performance liquid chromatography: Examine the detector type and parameters,
the type and specifications of the chromatographic column packing, the type and elution
method of the mobile phase, the data acquisition time, the column temperature, the flow
rate, the injection volume, etc.
Gas chromatography method: Examine the detector type and parameters, the type and
specifications of the chromatographic column packing, the heating method (such as
programmed heating), the data acquisition time, the injection port temperature, the split
ratio, the carrier gas flow rate, the injection volume, etc.
4.1.6.2 Determination of the measurement time
The characteristic spectrum is formulated by high performance liquid chromatography
and gas chromatography; the measurement time of the characteristic spectra is usually
not more than 1 h. According to the measurement time t under the chromatographic
conditions determined in 4.1.6.1, continue to elute with the strongest elution conditions
after the determination time t; examine the chromatographic peaks after the
measurement time t; obtain a spectra which has a recording time of 2 times the
measurement time (2t), to ensure that the main components contained in the specimen
are reflected in the spectra and meet the principle of maximizing the amount of effective
information.
value; issue a validation test report.
4.1.8 Determination
Take the specimen solution and the reference solution respectively. Inject them into the
chromatograph. Perform the determination according to the determined
chromatographic conditions (see 4.1.6.1). Record the chromatogram.
4.1.9 Characteristic spectra and technical parameters
4.1.9.1 Selection of characteristic peaks
Use the similarity evaluation system software of Chinese medicine chromatographic
fingerprints or other appropriate analysis software, to superimpose the chromatograms
of 15 batches or more samples; select the common chromatographic peaks in the
chromatograms of each batch of samples; use Arabic nume...