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Investigating method for azolephosphate, freeze-dried and relevant mass and content of its injecta

A technology for zoledronic acid and related substances, which is applied in the field of inspection of zoledronic acid raw materials, lyophilization and related substances and content of injections, and can solve problems such as long equilibration time, high cost, and large damage to chromatographic columns , to achieve the effects of reducing damage, shortening inspection time, and reducing testing costs

Inactive Publication Date: 2005-11-09
YANGTZE RIVER PHARM GRP CO LTD
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Problems solved by technology

[0004] The traditional chromatographic inspection system of this product is basically an all-water phase, which does not contain an organic phase, and the equilibration time is too long, and it will cause great damage to the traditional chromatographic column and consume a lot of cost. It is necessary to find out a reasonable chromatographic system. To formulate simple, rapid and stable test methods for related substances and contents in order to effectively control the quality of this product

Method used

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Embodiment Construction

[0008] The present invention is achieved in this way, the zoledronic acid raw material, freeze-drying and injection related substance detection method thereof are: take octadecyl bonded silica gel as filler; 0.03% tetrabutylammonium hydroxide aqueous solution [get 10 0.3ml of aqueous solution of tetrabutylammonium hydroxide is added to 100ml of water] (phosphoric acid adjusts pH=2.55)-acetonitrile (100:20) is the mobile phase, and the detection wavelength is 218nm, and the number of theoretical plates should be calculated with the peak of zoledronic acid Not less than 2500. The content determination method is as follows: using octadecylsilane bonded silica gel as filler, acetonitrile-tetrahydrofuran-0.05mol / L ammonium dihydrogen phosphate (4:1:100, phosphoric acid to adjust pH=2.55) as mobile phase, and detection wavelength 218nm. The number of theoretical plates calculated based on the peak of zoledronic acid should not be less than 2500.

[0009] Raw materials of zoledroni...

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Abstract

The invention discloses a method for measuring the substance and content of azolephosphate material, freeze-dried, its injection.It takes the 18 alkyl connected silica gel as the filling reagent and 0.03% hydrogen-oxygen four butyl ammonium aqueous solution- B (100:20) as the flowage thing.The examining wave-length is 218 nms and the academic number of planks calculated by apex of can not be lower than 2500.The flowage thing can be prepared as follows: mix 10% hydrogen-oxygen four butyl ammonium aqueous solution(0.3 mls) and 100 ml water,then regulate the pH with the phosphoric acid to 2.55; Or take B- four hydrogen furan-0.05mols / L phosphoric acid 2hydrogen ammonium(4:1:100) as the flowage thing. The method is simple, fast and stable, thus it can control the quality of production effectively.

Description

technical field [0001] The invention relates to a method for testing related substances and contents of zoledronic acid raw material, freeze-drying and injection thereof. Background technique [0002] Malignant hypercalcemia is a life-threatening bone metabolic complication caused by cancer. About 10% of cancer patients suffer from hypercalcemia or elevated bone calcium levels. Zoledronic acid is a drug developed by Novartis for the treatment of hypercalcemia. It was first launched in Canada in 2000 and is currently available in the United States, the United Kingdom and other countries. Sale. [0003] Zoledronic acid is a heterocyclic third-generation bisphosphonate drug, and it is the bisphosphonate compound that has shown the strongest effect in clinical trials so far. This product can be injected intravenously conveniently, shortening the time required for intravenous injection of pamidronate disodium from 2 hours to 5 minutes, requiring short clinical nursing time, sma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 蔡伟张玉斌曹燕锋刘江华戚苏明王喜习尹必喜
Owner YANGTZE RIVER PHARM GRP CO LTD
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