Method for measuring residual amount of Triton X-100 in HBsAg stock solution expressed by recombinant Saccharomyces cerevisiae
A technology of recombinant Saccharomyces cerevisiae and an assay method, applied in the field of preparation of recombinant genetic engineering hepatitis B vaccine, can solve the problems of accuracy interference, inability to effectively remove impurity interference, system inconsistency, etc., and achieve the effect of accurate residual amount
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example 1
[0064] Instrument:
[0065] Waters Alliance 2695 high performance liquid chromatograph, Waters PDA2996 detector, Waters Empower software, Mettler-Toledo XP205 electronic analytical balance.
[0066] Reagents and reagents:
[0067] Triton X-100 reference substance: purchased from Sigma Company, batch number 100M0128V; methanol: HPLC grade, purchased from Merck Company; water: ultrapure water.
[0068] process:
[0069] In the preparation step of the reference substance solution, the Triton X-100 reference substance was dissolved in 90% methanol solution to make a series of concentrations of 1 μg / ml, 2.5 μg / ml, 5 μg / ml, 10 μg / ml, and 20 μg / ml Reference substance solution.
[0070] In the activation step, select Waters HLB 1cc solid phase extraction column, first pass through 1ml of methanol, then pass through with 1ml of water.
[0071] In the protein content detection step, it is detected that the protein content in the stock solution A of the test product is 20 μg / ml; t...
example 2
[0080] Instrument:
[0081] Waters Alliance 2695 high performance liquid chromatograph, Waters PDA2996 detector, Waters Empower software, Mettler-Toledo XP205 electronic analytical balance.
[0082] Reagents and reagents:
[0083] Triton X-100 reference substance, purchased from Sigma Company, batch number 100M0128V; methanol: HPLC grade, purchased from Merck Company; water: ultrapure water.
[0084] process:
[0085] In the preparation step of the reference substance solution, the Triton X-100 reference substance was dissolved in 90% methanol solution to make a series of concentrations of 1 μg / ml, 2.5 μg / ml, 5 μg / ml, 10 μg / ml, and 20 μg / ml Reference substance solution.
[0086] In the activation step, select Waters HLB 1cc solid phase extraction column, first pass through 1ml of methanol, then pass through with 1ml of water.
[0087] In the protein content detection step, it is detected that the protein content in the stock solution C of the test product is 20 μg / ml; t...
example 3
[0096] Instrument:
[0097] Waters Alliance 2695 high performance liquid chromatograph, Waters PDA2996 detector, Waters Empower software, Mettler-Toledo XP205 electronic analytical balance.
[0098] Reagents and reagents:
[0099]Triton X-100 reference substance: purchased from Sigma Company, batch number 100M0128V; methanol: HPLC grade, purchased from Merck Company; water: ultrapure water.
[0100] process:
[0101] In the preparation step of the reference substance solution, the Triton X-100 reference substance was dissolved in 90% methanol solution to make a series of concentrations of 1 μg / ml, 2.5 μg / ml, 5 μg / ml, 10 μg / ml, and 20 μg / ml Reference substance solution;
[0102] In the activation step, select Waters HLB 1cc solid phase extraction column, first pass through 1ml of methanol, then pass through with 1ml of water.
[0103] In the protein content detection step, it is detected that the protein content in the stock solution E of the test product is 20 μg / ml; th...
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