Method for production of comparison sample of visible particles
A production method and sample technology, which are applied in the production field of visible foreign matter comparison samples, can solve the problems of increased concentration distribution error, increase, and can not meet the requirements, etc., and achieve the effect of ensuring the concentration
Inactive Publication Date: 2013-03-27
BEIJING HAIAN HONGMENG STANDARD SUSNCE TECH
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Problems solved by technology
[0004] When the existing technology is used to subpackage under stirring conditions, for particles with a particle size of 50 μm, the standard particle size of visible foreign matter is 49.4 μm, the standard deviation of particle size is 5.87%, the maximum particle size is 58 μm, and the minimum is 40 μm; The installation error increases with the decrease of the concentration, from a few percent to several hundred percent, which cannot meet the requirements
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[0037] First, clean the ampoule in a class 10,000 purification room until it is clean, fill it with 10mL of clean water to ensure no dust; then disperse a small amount of 50μm particle samples on the slide in the class 10,000 purification room; select a particle under a microscope, Use an image analyzer to determine the particle size of the selected particles. If the particle size is within 50 μm ± 1 μm, it is a selected particle, and use a particle picker with a pickup head diameter of 50 μm to pick up the selected particles under the microscope , put it into the prepared ampoule; after that, pick up 4 more capsules according to the above method to fill the ampoule with 5 capsules to reach the required number of particles; finally burn the ampoule with a blowtorch; put the sealed ampoule in the detection light box After it is determined that there are no impurities and the number of particles is 5, it is a product that meets the requirements; after the sample label is pasted, ...
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Abstract
The invention discloses a method for production of a comparison sample of visible particles. The method is as follows: a clean sample bottle required is prepared firstly; secondly, according to the granule quantity needed by the required density, the granules with determined diameter are picked by a granule picker through a microscope and then put inside the prepared clean sample bottle; finally, the comparison sample of the visible particles in accordance with client requirements can be got after sintering, checking and packing. The invention has the advantages of being able to pick granules in line with the quantity required by clients and ensuring the concentration of the sample as well as being easy to handle. The invention can provide much better comparison samples of the visible particles for clients.
Description
technical field [0001] The invention relates to the field of standard samples for comparison of visible foreign matter, in particular to a production method of a comparison sample for visible foreign matter. Background technique [0002] Visible foreign matter refers to insoluble substances that exist in injections and ophthalmic liquid preparations and can be observed visually under specified conditions, and their particle size or length is usually greater than 50 μm. Appendix IX H of Part Two of the Pharmacopoeia of the People's Republic of China stipulates the inspection method for visible foreign matter. The Pharmacopoeia stipulates that visible foreign matter must be inspected. Light inspection method or light scattering method can be used. Both methods require visible foreign matter to be compared with standard samples. Compare the standard. [0003] In the existing product and production method, particles with a particle size or length of 40, 50, and 60 μm are mixed ...
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IPC IPC(8): G01N1/28
Inventor 李力周小龙张文阁刘艳丽李丽华
Owner BEIJING HAIAN HONGMENG STANDARD SUSNCE TECH