GB/T 36390-2018 in English

Overview of the standard

GB/T 36390—2018 specifies the technical requirements, test methods, packaging, transportation, storage and shelf life of lysozyme, and is applicable to lysozyme extracted from biological materials.

Definition and function of lysozyme

Lysozyme is a hydrolase that specifically acts on the cell wall of microorganisms and can hydrolyze the $\beta-1,4$ glycosidic bond between $N$-acetylmuramic acid and $N$-acetylglucosamine. Its activity unit is defined as: the amount of enzyme required to reduce the absorbance value by 0.001 per minute in 0.1 mol/L phosphate buffer (pH 6.2) with Micrococcus lysodeikticus as the substrate.

Technical requirements

Test methods

Packaging, transportation and storage

• Packaging:The inner packaging material is clean and pollution-free, and the seal is tight; the outer packaging box meets the requirements of GB/T191.
• Transportation:Transport under frozen conditions to ensure cleanliness, dryness, and protection from rain and sun.
• Storage: Freeze-dried products should be stored below $-20^\circ\mathrm{C}$.

Background and significance of standard formulation

Lysozyme plays an important role in biotechnology, medicine and food industries. The formulation of this standard promotes its industrialization process and ensures product quality and safety.

Implementation suggestions

1. Enterprises should strictly carry out production and inspection in accordance with the requirements of the standard to ensure that the products meet the technical indicators.
2. Strengthen employee training, especially in the detection of impurities, and master the methods of Appendix A and B.
3. It is recommended to regularly inspect production equipment and laboratory environment to avoid the introduction of pollution sources.