√ Technical Performance ofthe Reagent Kit
(1) Validation of active ingredients: Qualified
(2) Sterility testing: Qualified
(3) Endotoxin detection: Qualified
(4) Mouse oocyte activation test (activation efficiency test): Qualified The product is certified for release only after meeting all the above requirements.
√ Reagent Kit Operating Procedure
1.Active Ingredient Validation: Randomly select one tube of Solution A or B from the packaged kit, dilute to working concentration, and verify effective concentration using HPLC.
2.Shelf-Life Validation: Retain 2 kits per batch for shelf-life testing. Test one tube every three months using HPLC. Ensure active ingredients remain 0::90% of initial concentration after one year.
3.Sterility Testing: Randomly select 2 tubes of Solution A and 2 tubes of Solution B per batch, dilute and culture for bacteria. If S10 colonies and no pathogens after 24h at 37°C, it is qualified.

4.Endotoxin Testing: Sample each batch to measure endotoxin levels. Both A and B solutions must have <0.25 EU/mL to be qualified.
5.Mouse Oocyte Activation Test: Randomly sample each batch, prepare working concentration, and activate mouse MI oocytes following instructions. Using Solution A, activate 0::20 oocytes per test, with 0::70% showing at least one pronucleus after 16 hours to be qualified.
Quality Certification: The product is certified for release only after meeting all the above requirements.
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