GB/T 40486-2021 in English
VALIDDetermination of melittin content in bee venom powder—High performance liquid chromatography
- Issued on:2021-08-20
- Implemented on:2022-03-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 40486-2021蜂毒干粉中蜂毒溶血肽含量的测定 高效液相色谱法》由TC601(全国蜂产品标准化技术委员会)归口,主管部门为中华全国供销合作总社。
Introduction
Analysis of standard technical framework
| Technical elements | GB/T40486-2021 | International similar standards | Conventional methods in the industry |
|---|---|---|---|
| Detection limit | 15mg/g | 20mg/g(USP) | 30mg/g(ELISA method) |
| Recovery range | 85.1%-108.4% | 80%-110% | 75%-95% |
| Analysis time | 8 minutes/sample | 10 minutes | 45 minutes |
Core technology innovation
The 300SB-C18 chromatographic column is used with a gradient elution system (0.1% trifluoroacetic acid-water solution/0.08% trifluoroacetic acid-acetonitrile) to achieve precise separation of bee venom hemolytic peptides at a UV detection wavelength of 220nm, which improves the separation efficiency by 3 times compared with traditional methods.
Implementing critical control points
Application case of a bee product company
After the implementation of this standard:
- The qualified rate of test batches increased from 82% to 97%
- The cost of single sample testing was reduced by 40%
- The life of the chromatographic column was effectively extended through pretreatment with 0.2μm aqueous filter membrane
Analysis of standard evolution
This standard fills the gap in the field of detection of active ingredients in bee venom in my country, and its technical route refers to:
- Quality requirements of EU EDQM for bee venom preparations
- USP40-NF35 chromatography system suitability standard of the United States Pharmacopoeia
- Detection guide for bioactive peptides of the Ministry of Health, Labor and Welfare of Japan
Operational risk warning
Special attention should be paid:
- GB/T6682 grade 1 water must be used to dissolve the standard sample
- Column temperature control deviation ≤±1℃
- Sample storage temperature below -20℃

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