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Method for determining palladium metal residues in dezocine raw materials

A metal residue and determination method technology, applied in the field of chemical detection, can solve the problems of low safety and long time consumption, and achieve the effect of saving time

Inactive Publication Date: 2018-08-24
南京明捷生物医药检测有限公司
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  • Claims
  • Application Information

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Problems solved by technology

In the production of dezocine, it is necessary to control the content of palladium in the raw material drug of dezocine. Currently, microwave digestion or graphite digestion is generally used for pretreatment of the raw material drug of dezocine, but this method is low in safety and takes a long time ;

Method used

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  • Method for determining palladium metal residues in dezocine raw materials
  • Method for determining palladium metal residues in dezocine raw materials
  • Method for determining palladium metal residues in dezocine raw materials

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Embodiment Construction

[0030] The following is a description of the relevant reagents for the test:

[0031]

[0032] A kind of assay method of palladium metal residue in dezocine bulk drug, the steps are as follows:

[0033] S1, sample preparation: adopt the analytical balance of model AB135-s of Mettler Toledo company to weigh dezocine 25mg to 5mL volumetric flask, add blank solvent (ACN: 5%; HNO 3 =1:1) Dissolve, constant volume, and mix; take 1mL of the above solution into a 10mL volumetric flask, and use 2% HNO 3 Constant volume, mixing, as the sample solution.

[0034] S2, the model that Thermo Fisher company is set is the plasma mass spectrometer of Thermo i CAP RQ, and its parameter is as follows:

[0035] The nebulizer flow rate is 0.9936L / min; the plasma flow rate is 14L / min; the RF power is 1550W; the detection mode is KED; the sample flushing time is 30 seconds; the sample lifting time is 30 seconds;

[0036] S3. Configure a blank solvent. The blank solution includes blank solvent ...

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Abstract

The invention provides a method for determining palladium metal residues in dezocine raw materials and specifically relates to the field of chemical detection. According to the method, the content ofpalladium in the dezocine raw materials is controlled, a sample is directly dissolved with an acetonitrile water liquor with proper concentration, a liquor is diluted with 2% HNO3 to required concentration, and the content of palladium elements is determined with a one-point external standard method by use of an ICP-MS (inductively coupled plasma source mass spectrometer). Compared with microwavedigestion or graphite digestion, the treatment method is safer and time-saving.

Description

technical field [0001] The invention belongs to the field of chemical detection, and in particular relates to a method for determining palladium metal residues in dezocine raw materials. Background technique [0002] In recent years, domestic and foreign restrictions on heavy metals in various synthetic drugs, animal and plant extracts, nutritional products and food have become increasingly stringent, and the export of related domestic industries is facing huge challenges. Synthetic pharmaceuticals also face the same problem. Metal catalysts are often used in the synthesis process of pharmaceutical raw materials, and countries also have strict requirements on the limits of metal reagent residues. The United States Pharmacopoeia USP has also made major revisions to the heavy metal testing of pharmaceuticals, and regulations have become more stringent. [0003] Dezocine is a drug for relieving postoperative pain, muscular tissue and organ and cancer analgesia; it has the char...

Claims

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Application Information

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IPC IPC(8): G01N21/73
CPCG01N21/73
Inventor 仇好
Owner 南京明捷生物医药检测有限公司
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