Method for determining residual N,N-dimethylacetamide solvent in bulk drug
A technology of dimethylacetamide and raw materials, applied in the field of chemical analysis, can solve problems that have not yet been seen, and achieve the effects of strong specificity, improved detection accuracy, and strong accuracy
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Embodiment 1
[0054]
[0055]
[0056] Diluent: N-Methylpyrrolidone
[0057] Experimental steps:
[0058] Need testing solution: take 1 g of vonoprazan fumaric acid crude drug, accurately weigh it, place it in a 10ml measuring bottle, shake to dissolve the fumaric acid vonoprazan crude drug completely, then dilute to the scale, shake well, Instantly.
[0059] N,N-dimethylacetamide reference substance solution: Take about 109mg of N,N-dimethylacetamide, weigh it accurately, put it in a 100ml measuring bottle, dissolve it with diluent and dilute to the mark, shake well, and use it as a control stock solution; accurately measure 1ml of the stock solution of the reference substance, put it in a 10ml measuring bottle, dilute to the mark with diluent, and shake well. (109μg / ml)
[0060] Trace amount of N,N-dimethylacetamide reference substance solution: Accurately measure 1ml of the reference substance solution, put it in a 25ml measuring bottle, dilute to the mark with diluent, and shake ...
Embodiment 2
[0065]
[0066]
[0067] Diluent: N-Methylpyrrolidone
[0068] Experimental steps:
[0069] Need testing solution: take 1 g of vonoprazan fumaric acid crude drug, accurately weigh it, place it in a 10ml measuring bottle, shake to dissolve the fumaric acid vonoprazan crude drug completely, then dilute to the scale, shake well, Instantly.
[0070] N,N-dimethylacetamide reference substance solution: Take about 109mg of N,N-dimethylacetamide, weigh it accurately, put it in a 100ml measuring bottle, dissolve it with diluent and dilute to the mark, shake well, and use it as a control stock solution; accurately measure 1ml of the stock solution of the reference substance, put it in a 10ml measuring bottle, dilute to the mark with diluent, and shake well. (109μg / ml)
[0071] 100% sample recovery solution: Take about 1g of the sample, weigh it accurately, put it in a 10ml measuring bottle, add the reference substance solution to dissolve and dilute to the mark, shake well, and...
Embodiment 3
[0074]
[0075]
[0076] Diluent: N-Methylpyrrolidone
[0077] Experimental steps:
[0078] Need testing solution: take 1 g of vonoprazan fumaric acid crude drug, accurately weigh it, place it in a 10ml measuring bottle, shake to dissolve the fumaric acid vonoprazan crude drug completely, then dilute to the scale, shake well, Instantly.
[0079] N,N-dimethylacetamide reference substance solution: Take about 109mg of N,N-dimethylacetamide, weigh it accurately, put it in a 100ml measuring bottle, dissolve it with diluent and dilute to the mark, shake well, and use it as a control stock solution; accurately measure 1ml of the stock solution of the reference substance, put it in a 10ml measuring bottle, dilute to the mark with diluent, and shake well. (109μg / ml)
[0080] Trace amount of N,N-dimethylacetamide reference substance solution: Accurately measure 1ml of the reference substance solution, put it in a 25ml measuring bottle, dilute to the mark with diluent, and shak...
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