Method for determining element impurities in OTC soft capsule by using inductively coupled plasma mass spectrometry technology

A technology that couples plasma and uses inductance. It is applied in the field of elemental impurities and can solve the problem of no safe and reliable detection method for elemental impurities.

Pending Publication Date: 2021-10-29
HUMANWELL PURACAP PHARM WUHAN CO LTD
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  • Abstract
  • Description
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Problems solved by technology

[0005] Main purpose of the present invention is to provide a kind of method that uses inductively coupled plasma mass spectrometry to measure elemental i...

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  • Method for determining element impurities in OTC soft capsule by using inductively coupled plasma mass spectrometry technology
  • Method for determining element impurities in OTC soft capsule by using inductively coupled plasma mass spectrometry technology
  • Method for determining element impurities in OTC soft capsule by using inductively coupled plasma mass spectrometry technology

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Embodiment Construction

[0032] In order to make the technical problems, technical solutions and beneficial effects solved by the present invention clearer, the present invention will be described in further detail below in conjunction with the examples. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

[0033] Specific analysis and detection methods include:

[0034] (1) Prepare the standard solutions of the impurities of each element; use 1% dilute nitric acid and mixed element standard solutions to prepare 5 standard solutions with different concentrations (solutions 1-5). The concentration of the standard solution in Table-1 is calculated according to the limit of the target element, and it is required to cover the concentration of 50% to 150% of the target element. The element limit refers to: calculate the limit value according to the maximum daily dosage and element PDE of different products...

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Abstract

The invention provides a method for determining element impurities in OTC soft capsules by using an inductively coupled plasma mass spectrometry technology. According to the method, an ICP-MS detection method with high sensitivity and accuracy can be established according to the maximum daily dose of different products and the daily permissible exposure (PDE) of elements; according to the present invention, the ICP-MS can be used to determine Cd, Pb, As, Hg, Co, V, Ni, Ag, Tl, Au, Ir, Mo, Os, Pd, Pt, Rh, Ru, Sb, Sn, Ba, Cr, Cu, Li, Se and other element impurities in the OTC capsule; and the method can meet the determination requirements of a variety of heavy metal elements in the OTC capsule, and has high accuracy, precision and repeatability.

Description

technical field [0001] The invention relates to the field of drug quality detection, in particular to a method for detecting elemental impurities in OTC soft capsules using inductively coupled plasma mass spectrometry. Background technique [0002] Metal elements are highly toxic and have a long incubation period, and can be enriched along the food chain, causing obvious harm to the human body. Metal elements that enter various environments such as the atmosphere, water body, and soil can be absorbed by animals through various channels such as the respiratory tract, digestive tract, and skin. When accumulated to a certain amount, they will damage the nervous system, hematopoietic system, and digestive system, reducing body immunity. In recent years, more and more attention has been paid to the dissolution detection and limit of metal impurities at home and abroad, and international standards and guidelines for the limit of metal elements have been issued, such as US Pharmac...

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Application Information

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IPC IPC(8): G01N27/626
CPCG01N27/626
Inventor 聂磊蒋春来高勇罗丹妮周祺敏钟坚白蕾
Owner HUMANWELL PURACAP PHARM WUHAN CO LTD
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