A kind of formaldehyde derivative test method
A test method and technology of derivatization reagents, applied in the field of formaldehyde derivatization test, can solve the problems of time-consuming, complicated derivatization reaction process, easy to generate interference, etc., and achieve the effect of simplifying the test method, improving sensitivity and simple reaction
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Embodiment 1
[0056] Formaldehyde residue method verification in embodiment 1 rifampicin
[0057] 1. Instruments, reagents, reference substances and test substances
[0058] Instrument: one hundred thousandth analytical balance, gas chromatography-mass spectrometry (Agilent 7890A-5975C);
[0059] Solvents: formaldehyde solution (38.25%), methylamine hydrochloride (98%), dimethylsulfoxide (DMSO, HPLC), dicyclohexylcarbodiimide (DCC).
[0060] 2. Solution preparation
[0061] Derivative reagent: take 500mg DCC and 100mg methylamine hydrochloride, weigh them accurately, put them in a 100ml volumetric flask, dilute to the mark with DMSO, and shake well;
[0062] Blank solution: pipette 2.0ml of derivatization reagent and 2.0ml of DMSO respectively, put them in a 10ml digestion tube, wait until the temperature of the digestion instrument rises to 60°C, put the digestion tube into the digestion instrument for derivatization for 30min, after the digestion is completed, cool to room temperature, ...
Embodiment 2
[0190] Determination of formaldehyde residual content in the duloxetine hydrochloride starting material of embodiment 2
[0191] 1. Instruments, reagents, reference substances and test substances
[0192] Instruments: 1 / 100,000 analytical balance, gas phase-mass spectrometer;
[0193] Solvent: formaldehyde solution (38.25%), methylamine hydrochloride (HPLC), dimethyl sulfoxide (HPLC), strongly acidic cationic resin (AR);
[0194] 2. Solution preparation
[0195] Derivative reagent: take 500mg DCC and 100mg methylamine hydrochloride, weigh them accurately, put them in a 100ml volumetric flask, dilute to the mark with DMSO, and shake well;
[0196] Blank solution: Pipette 2.0ml of derivatization reagent and 2.0ml of DMSO into a 10ml digestion tank. After the temperature of the digestion instrument rises to 60°C, place the digestion tube in the digestion instrument for 30 minutes of derivatization. After the digestion is completed and cooled to room temperature, transfer 2.0ml...
Embodiment 3
[0216] Determination of residual formaldehyde content in febuxostat in embodiment 3
[0217] 1. Instruments, reagents, reference substances and test substances
[0218] Instrument: 1 / 100,000 analytical balance, coupled with gas chromatography-mass spectrometry;
[0219] Reagents: acetonitrile (HPLC), ethanol (HPLC), strongly acidic cationic resin (AR);
[0220] Reference substance: formaldehyde (38.25%);
[0221] Sample: febuxostat.
[0222] 2. Solution preparation
[0223] Derivative reagent: take 500mg DCC and 100mg methylamine hydrochloride, weigh them accurately, put them in a 100ml volumetric flask, dilute to the mark with DMSO, and shake well;
[0224] Blank solution: Pipette 2.0ml of derivatization reagent and 2.0ml of DMSO into a 10ml digestion tank. After the temperature of the digestion instrument rises to 60°C, place the digestion tube in the digestion instrument for 30 minutes of derivatization. After the digestion is completed and cooled to room temperature, tra...
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