GB/T 43809-2024 PDF English
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GB/T 43809-2024: Technical requirements for establishing characteristic spectra of plant extracts feed Additives
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT43809-2024
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 numerals to mark each common
chromatographic peak.
Generally, select 4 ~ 8 common chromatographic peaks as characteristic peaks. The
characteristic peaks shall be distributed in different positions of the chromatogram as
much as possible. The characteristic peaks shall include unique ingredients, effective
ingredients or labeled ingredients. For extracts with fewer components, the number of
characteristic peaks can be determined according to actual conditions. If necessary,
trace components other than the main effective ingredients can be selected as
characteristic peaks for purified extracts. The signal-to-noise ratio of the selected
characteristic peaks is ≥ 3.
4.1.9.2 Identification of characteristic peaks
The characteristic spectra shall clarify the chemical structure and chemical name of its
characteristic peaks as much as possible; generally use reference substances for
confirmation. If necessary, for unknown characteristic peaks that cannot obtain
reference substance, liquid chromatography-mass spectrometry (LC-MS) or gas
chromatography-mass spectrometry (GC-MS) can be used to speculate the possible
compound structure according to the actual situation, so as to determine the specificity
of the established spectra based on the confirmed or speculated characteristic peak
components.
4.1.9.3 Selection of S peak
Select a reference chromatographic peak as the S peak in the order of main effective
ingredients, unique ingredients, secondary effective ingredients, labeled ingredients
that exist in large quantities or have relatively stable content in each batch. If there is
no reference material for a suitable reference substance, a stable chromatographic peak
with a large peak area can be selected as the S peak.
4.1.9.4 Requirements for relative retention time of characteristic peaks
Take the retention time of S peak as 1, to calculate the relative retention time of each
characteristic peak and S peak. Take the average value of the relative retention time of
each characteristic peak among all samples as the specified value. The relative standard
deviation RSD of the relative retention time of each batch of samples shall not be
greater than 3%. Relative retention time is used as the basis for identifying characteristic
spectra.
4.1.9.5 Requirements for relative peak area of characteristic peaks
If necessary, the relative peak area between the designated characteristic peak and the
S peak or characteristic peaks shall be specified. The peak area ratio between the
designated characteristic peak and the S peak or characteristic peak shall be calculated
based on the chromatograms of more than 15 batches of samples, to determine the
relatively stable ratio range.
4.1.9.6 Generation of characteristic spectra
Based on the chromatograms of more than 15 batches of samples, the Chinese medicine
chromatographic fingerprint similarity evaluation system software or other appropriate
analysis software shall be used for data processing; the selected characteristic peaks
shall be matched to generate characteristic spectra.
When the component categories differ greatly and one spectra is difficult to reflect all
its characteristic components, multiple characteristic spectra can be established
according to the properties of the characteristic components and the measurement
results under multiple chromatographic conditions.
If necessary, trace components of purified extracts can be selected to establish
characteristic spectra.
For the application of characteristic spectra, see Appendix A.
4.1.9.7 Characteristic spectra information
The number of characteristic peaks in the characteristic spectra shall be displayed; the
positions of the S peak and each characteristic peak shall be marked with Arabic
numerals. The specified value of the relative retention time of each characteristic peak
and the S peak in the characteristic spectra shall be stated; the allowable deviation range
between the measured value and the specified value shall be specified. If necessary, the
relative peak area value between the specified characteristic peaks can be specified to
be within a certain range.
The characteristic spectra "graph" shall contain the following information:
a) The abscissa of the "graph" is the retention time, in minutes (min);
b) The ordinate of the "graph" is the chromatographic peak response, the unit is
Appendix B
(Informative)
Characteristic spectra report example - Characteristic spectra of licorice extract
B.1 Source
Dry powder made by extracting and processing, through 70% ethanol, the dried roots
and rhizomes of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza
glabra L. of the leguminous plants.
B.2 Determination method
Determined in accordance with the high performance liquid chromatography method
(General Rule 0512) of the Veterinary Pharmacopoeia of the People's Republic of China.
B.3 Preparation of specimen solution
Weigh about 0.2 g of licorice extract. Place in a stoppered conical flask. Accurately add
25 mL of 70% ethanol solution. Ultrasonically treat (power 250 W, frequency 40 kHz)
for 10 min. Let it cool naturally. Weigh the mass. Make up the lost mass with 70%
ethanol. Shake well. Let it stand. Take the supernatant and filter through a 0.45 μm
organic membrane. Take the filtrate as the specimen solution.
B.4 Preparation of reference solution
Weigh 5 mg (accurate to 0.01 mg) of apigenin (CAS No.: 74639-14-8, purity not less
than 98.0%), liquiritin (CAS No.: 551-15-5, purity not less than 98.0%), glycyrrhizic
acid (CAS No.: 1405-86-3, purity not less than 98.0%) respectively. Place them in a 25
mL brown volumetric flask. Add methanol to ultrasonically dissolve and dilute to the
mark, to prepare a reference stock solution containing 0.2 mg of reference substance
per 1 mL.
B.5 Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as filler (column length 25 cm, inner diameter 4.6
mm, particle size 5 μm). Use acetonitrile as mobile phase A; use 0.05% phosphoric acid
solution as mobile phase B; perform gradient elution according to the provisions in
Table B.1: the flow rate is 1.0 mL/min, the column temperature is 30 °C, the detection
wavelength is 276 nm. The theoretical plate number calculated based on the
glycyrrhizin peak shall be no less than 50000.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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