Moroxydine hydrochloride purity standard substance as well as preparation method and application thereof

Abstract

The invention discloses a moroxydine hydrochloride purity standard substance as well as a preparation method and application thereof. The preparation method comprises the following steps: 1) samplingmoroxydine hydrochloride raw material powder, and measuring the mass percentage content of the moroxydine hydrochloride in the moroxydine hydrochloride raw material powder by a high-performance liquidchromatography area normalization method to obtain the purity definite value of the moroxydine hydrochloride raw material powder; 2) measuring the water mass percentage content, the non-volatile impurity mass percentage content and the organic volatile impurity mass percentage content of the moroxydine hydrochloride raw material powder, and performing calculation by combining the purity definitevalue of the moroxydine hydrochloride raw material powder measured in the step 1) and according the following formula I to obtain the moroxydine hydrochloride purity standard substance with the definite value, wherein the formula I is P=[100%-Xw-Xn-Xv]*100%. The moroxydine hydrochloride purity standard substance can serve as a standard substance, is applied to detection on medicine residue in livestock products, and provides technical support and substance guarantee for establishment of a national agricultural product quality safety risk evaluation, monitoring and tracing system.

Description

technical field

[0001] The invention relates to a purity standard substance of morpholine guanidine hydrochloride, a preparation method and application thereof, and belongs to the technical field of standard quantity transfer in stoichiometry. Background technique

[0002] Prohibited and restricted drugs are seriously abused in the process of animal husbandry. Because of their strong toxic side effects and toxic effects, and the residues in animal tissues will be transmitted to humans through the food chain, long-term trace intake can cause various diseases. Hazard to human health. Prohibited and restricted drugs have become an important parameter in the risk assessment and monitoring activities of the agricultural product quality and safety of the Ministry of Agriculture. In order to ensure the consistency, comparability, traceability and accuracy and reliability of the measurement results, corresponding reference materials are urgently needed.

[0003] Moroxydine hydrochl...

Examples

Embodiment 1

[0058] Embodiment 1, the definite value of morpholinidine hydrochloride purity standard substance

[0059] Preparation of morpholine guanidine hydrochloride raw material powder: After the pure morpholine guanidine hydrochloride raw material is through infrared and NMR after carrying out qualitative and purity initial confirmation, be placed in the grinder and fully grind, the raw material after grinding is put into vacuum oven, in 45 Under the condition of ℃, dry at low pressure (below -0.1Mpa) for 24 hours, place the raw material of pure morpholine guanidine hydrochloride dried under reduced pressure in a clean glass vessel, stir and mix well. Adopt liquid chromatography (ultraviolet detector, UV) to carry out the preliminary inspection of homogeneity to this raw material, after the inspection is qualified, the morpholine guanidine hydrochloride candidate is sub-packed in clean vials, and the vial specification is 5.0mL, in Strict washing measures are used to clean before sub...

technical field

[0001] The invention relates to a purity standard substance of morpholine guanidine hydrochloride, a preparation method and application thereof, and belongs to the technical field of standard quantity transfer in stoichiometry. Background technique

[0002] Prohibited and restricted drugs are seriously abused in the process of animal husbandry. Because of their strong toxic side effects and toxic effects, and the residues in animal tissues will be transmitted to humans through the food chain, long-term trace intake can cause various diseases. Hazard to human health. Prohibited and restricted drugs have become an important parameter in the risk assessment and monitoring activities of the agricultural product quality and safety of the Ministry of Agriculture. In order to ensure the consistency, comparability, traceability and accuracy and reliability of the measurement results, corresponding reference materials are urgently needed.

[0003] Moroxydine hydrochl...

Examples

Embodiment 1

[0058] Embodiment 1, the definite value of morpholinidine hydrochloride purity standard substance

[0059] Preparation of morpholine guanidine hydrochloride raw material powder: After the pure morpholine guanidine hydrochloride raw material is through infrared and NMR after carrying out qualitative and purity initial confirmation, be placed in the grinder and fully grind, the raw material after grinding is put into vacuum oven, in 45 Under the condition of ℃, dry at low pressure (below -0.1Mpa) for 24 hours, place the raw material of pure morpholine guanidine hydrochloride dried under reduced pressure in a clean glass vessel, stir and mix well. Adopt liquid chromatography (ultraviolet detector, UV) to carry out the preliminary inspection of homogeneity to this raw material, after the inspection is qualified, the morpholine guanidine hydrochloride candidate is sub-packed in clean vials, and the vial specification is 5.0mL, in Strict washing measures are used to clean before sub...

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