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A method for removing elemental impurities and pigments in sugammadex sodium refined products

A technology for sodium sugammadex and elemental impurities, which is applied in the field of removing elemental impurities and pigments in refined sodium sugammadex, can solve the problems of unconsidered element impurities, complicated steps, inconvenient operation, etc., so as to reduce the risk of toxicity , the process is simple, the effect of low cost

Active Publication Date: 2021-02-26
HEFEI BOSIKC PHARMTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method does not use column chromatography, dialysis and other methods, but the steps are cumbersome, requiring multiple conversions between free acid and salt, and the operation is inconvenient
In addition, the risk of elemental iodine from mineral sources and the introduction of more elemental impurities during the industrial production of strongly alkaline reaction systems has not been considered.

Method used

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  • A method for removing elemental impurities and pigments in sugammadex sodium refined products
  • A method for removing elemental impurities and pigments in sugammadex sodium refined products
  • A method for removing elemental impurities and pigments in sugammadex sodium refined products

Examples

Experimental program
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Effect test

Embodiment 1

[0063] Take 100g of sugammadex sodium refined product, add 300g of water to dissolve until clear, stir and add 190g of acetone at room temperature, after the addition, the solution becomes slightly turbid. The solution was transferred to a separatory funnel, and the layers were allowed to stand, and an orange-yellow oily substance settled to the bottom. Separate the oil. The supernatant was transferred to the flask, and 1300g of acetone was added with stirring at room temperature, and a white solid was separated out, filtered by suction, and dried to obtain 83g of sugammadex sodium as a white solid, whose purity was 99.78% ( image 3 ), the purity of the product did not change significantly. The Fe content measured by ICP-MS is 4.1ppm, and all the other elemental impurities are less than 1ppm ( Figure 4 ). After detection of orange-yellow oil, its Fe content is 200ppm ( Figure 5 ).

Embodiment 2

[0065] Take 100g of sugammadex sodium refined product, add 200g of water to dissolve until clear, stir and add 290g of DMF at room temperature, after the addition, the solution becomes slightly turbid. The solution was transferred to a separatory funnel, and the layers were left to stand, and a small amount of oily matter sank to the bottom. The oil was separated, the supernatant was transferred to a flask, and 310 g of DMF was added with stirring at room temperature, a white solid was precipitated, filtered by suction, and dried to obtain 85 g of sugammadex sodium as a white solid, whose purity was 99.78 g by HPLC. %( Image 6 ), the Fe content measured by ICP-MS is 7.1ppm, and the rest of the elemental impurities are less than 1ppm ( Figure 7 )

Embodiment 3

[0067] Take 100g of sugammadex sodium refined product, add 400g of water to dissolve until clear, stir and add 750g of acetonitrile at room temperature, after the addition, the solution becomes slightly turbid. The solution was transferred to a separatory funnel, and the layers were left to stand, and a small amount of oily matter sank to the bottom. The oil was separated, the supernatant was transferred to a flask, and 1600 g of ethanol was added with stirring at room temperature, a white solid was precipitated, filtered by suction, and dried to obtain 73 g of sugammadex sodium as a white solid, whose purity was 99.78 g by HPLC. %( Figure 8 ), the Fe content measured by ICP-MS is 7.0ppm, and the rest of the elemental impurities are less than 1ppm ( Figure 9 )

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Abstract

The invention discloses a method for removing elemental impurities and pigments in sugammadex sodium refined product: dissolving sugammadex sodium refined product in an aqueous solution, adding a certain amount of poor solvent dropwise to make a small part of sugammadex sodium in the solution Sodium gluconate and most of the element impurities and pigments are precipitated. After separating the part of the precipitate, collect the sodium sugammadex contained in the mother liquor in the upper layer, and through direct concentration or solvent crystallization, most of the elements can be removed. Impurity products. The color of the obtained product becomes lighter, the content of elemental impurities is significantly reduced, and meets the requirements of ICH on the limit of elemental impurities, and the method is simple and safe to operate, has good economical efficiency, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical production and purification, in particular to a method for removing elemental impurities and pigments in sugammadex sodium refined products. Background technique [0002] The chemical name of sugammadex sodium is 6A, 6B, 6C, 6D, 6E, 7F, 6G, 6H-octa-S-(2-carboxyethyl)-6A, 6B, 6C, 6D, 6E, 7F, 6G, 6H-octathio-γ-cyclodextrin octasodium salt, the structural formula is: [0003] [0004] Sugammadex sodium is a new type of muscle relaxant reversal agent developed by Organon in the Netherlands. It is clinically used to reverse the neuromuscular blockade of rocuronium or vecuronium. It has a good curative effect and is extremely effective. good security. Since the European Union approved its listing in July 2008, it has been listed in Japan, South Korea, the United States and other countries, and it will be listed in China in 2018. [0005] Sugammadex sodium is a structurally modified γ-cyclod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/16
CPCC08B37/0003C08B37/0012
Inventor 潘攀郭辉吴友灵
Owner HEFEI BOSIKC PHARMTECH CO LTD
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