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Method and device for the quantitative analysis of solutions and dispersions by means of near infrared spectroscopy

A technology of dispersion liquid and near-infrared range, which is applied in the field of quantitative analysis and device for solutions and dispersion liquids by using near-infrared spectroscopy, and can solve the problems of not performing quantitative analysis and the like.

Inactive Publication Date: 2008-12-24
SANOFI AVENTIS DEUT GMBH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

which did not perform quantitative analysis

Method used

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  • Method and device for the quantitative analysis of solutions and dispersions by means of near infrared spectroscopy
  • Method and device for the quantitative analysis of solutions and dispersions by means of near infrared spectroscopy
  • Method and device for the quantitative analysis of solutions and dispersions by means of near infrared spectroscopy

Examples

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Effect test

example 1

[0059] The (quality) monitoring of the insulin filling is aimed at the quantitative control of the insulin content of 100% of the filled insulin ampoules. Here, the insulin content of the filled insulin suspension should deviate by only a maximum of + / −5% from the detected value. Anomalies should be detected without error.

[0060] In order to monitor the filling of simulated insulin, a set of crystalline Insuman - Calibration samples of insulin are calibrated, followed by checks on product samples. For calibration, insulin cartridges are used which have a precisely known insulin content of 90 to 120% of the nominal content. Baseline values ​​were determined by HPLC. Shake the cartridge thoroughly before measuring to allow a homogeneous suspension to exist.

[0061] Insulin spectra were received in transmission using a photodiode array-spectrometer (MCS 511 NIR 1.7). The measured wavelength range was 960 to 1760 nm, wherein the evaluation was carried out in the wavelengt...

example 2

[0069] The purpose of quality monitoring of insulin filling is to quantitatively control the insulin content of 100% of the filled insulin ampoules. Here, the insulin content of the filled insulin suspension should deviate by only a maximum of + / −5% from the declared value. Anomalies should be detected without error. The monitoring should take place either during filling on the moving insulin cartridge or after filling on the filled insulin cartridge. In both cases, the measurement is performed through the inner packaging (glass cartridge) and in the moving measured object.

[0070] In order to simulate the speeds present when filling insulin cartridges, an optical control machine type 288 from the company EISAI Machinery was used. This machine can be filled with insulin cartridges (suspension) and can rotate said cartridges to form a homogeneous suspension by means of metal balls contained in injection vials. A NIR measuring device is installed in this machine, the structu...

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Abstract

The invention relates to a method for quantifying the composition of a product, comprising the steps of: irradiating the product with a source of radiation in the near-infrared range; receiving radiation reflected or transmitted by the product, and for a certain number of different wavelengths, An output signal corresponding to the intensity of the received radiation is provided; based on said output signal, it is determined mathematically whether the product is within a predetermined overall standard. According to the invention, the moving product comprises a solution or a homogeneous dispersion, and the content of at least one substance contained in said dispersion or solution is quantitatively determined from said output signal. The invention also relates to a device for carrying out the method.

Description

technical field [0001] The present invention relates to a method and device for quantitative analysis of solutions and dispersions, such as solutions and dispersions for pharmaceutical purposes, using near-infrared spectroscopy. Background technique [0002] In the field of pharmaceuticals there is always a desire to improve quality control to increase drug safety. Meanwhile, the manufacture is to be carried out according to the current good manufacturing practice (cGMP), which is established by the drug regulatory agency (such as the US Food and Drug Administration, FDA). If there is a serious violation of this production management specification, the enterprise will be revoked the drug production license. [0003] An important part of GMP is the physical-chemical and microbiological testing and release of finished products. During testing, several parameters describing the quality of the product are checked and compared to product specifications. These specifications ar...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61B5/00G01N21/35B07C5/342G01N30/02
CPCG01J3/0218G01J3/024G01J3/1804G01J3/2803G01N21/3563G01N21/359G01N21/9027
Inventor H-J·普洛斯R·梅尔腾斯H·普林茨C-P·克里斯蒂安森
Owner SANOFI AVENTIS DEUT GMBH