Application of pre-laboratory instruments in the new pharmacopoeia

The 2010 edition of the Chinese Pharmacopoeia was published in January 2010. July 1, 2010 Implemented. The Chinese Pharmacopoeia is the core of the statutory national drug standards and an important technical basis for ensuring drug safety. Around the 2010 edition of "Chinese Pharmacopoeia" content Pharmacopoeia learning, summed up what the application before processing machines Tianjin Heng Austrian Technology Development Co. in the new pharmacopoeia.

First, high performance liquid chromatography

1. Azithromycin raw material related substance detection method was upgraded to HPLC method by the 2005 version of the TLC method, and the azithromycin raw material content determination method was upgraded from the 2005 version of the potency measurement to the HPLC method.

2 , 2010 edition is determined by high performance liquid chromatography with ferulic acid, the limit is not less than 0.10 %.

3 , 2005 version did not determine the content of Atractylodes medicinal herbs, 2010 edition uses high performance liquid chromatography with atractin as a reference substance to determine its content, the limit is not less than 0.30 %. Control the content of key ingredients.

4 , the detection method of the dissolution of clarithromycin capsules is changed from ultraviolet detection to liquid phase external standard method.

5 , 2010 version increased the liquid phase external standard method gradient detection of levofloxacin hydrochloride capsule related substances.

6. Identification in indapamide tablets ( 2 ) It is required that the retention times of the liquid phase main peaks are consistent, and we can see that the measurement accuracy is more stringent.

7, Hydrochloride, ester Suspension of the relevant test substance, the liquid detection increases.

8, ofloxacin 2005 Edition Pharmacopoeia was determined by perchloric titration positioning becomes liquid Pharmacopoeia 2010 Edition external standard assay.

9. The identification of levofloxacin 1 was changed from the color reaction of the standard YBH39772005 to the 2010 edition of the Pharmacopoeia standard to liquid phase identification: the main peaks were consistent; the content of levofloxacin was determined by perchloric acid localization titration to liquid phase external standard method.

We know that the HPLC method is a qualitative and quantitative method, and the new pharmacopoeia changes the detection method of the substance in a qualitative and quantitative direction. The HPLC method has the advantages of high speed, high efficiency, high sensitivity, etc. For the accuracy of measurement accuracy, Tianjin Hengao's online degasser and incubator can be applied.

Second, filtration sterilization method

Filters and membranes should be cleaned prior to use and sterilized or autoclaved with high pressure steam. The double-tube closed aseptic multi-filter (developed according to the United States Pharmacopoeia standard ) developed by Tianjin Hengao can be used. The filter device has the characteristics of simple installation, easy disinfection, improved parallel experiment accuracy, and reduced number of repeated filtration tests.

The most common method of filtering a biological sterilization indicator is defective Pseudomonas, for membrane pore size 0.22 μ m Tianjin Austria developed the filter constant; of SM, a membrane pore size of 0.45 μ m The filter developed by Tianjin Hengao.

Third, other instruments applicable to the new pharmacopoeia

Mixing - Oscillator , Magnetic Stirrer , Electric Stirrer

In conjunction with the new Pharmacopoeia requirements for ultrasonic cleaning / extraction parameters during drug sample preparation and extraction, Tianjin Hengao developed and produced the HU Pharmacopoeia and dual-frequency series ultrasonic cleaner equipment. For the dual-frequency series ultrasonic cleaner users can be 59/40 or 40. /33 Conversion between two frequencies.

Through the study of the new edition of the Pharmacopoeia, we know that special attention is paid to the safety, effectiveness and quality control of drugs. In this edition of the Pharmacopoeia, the number of drug testing items and testing methods has increased, and the standards have been improved. This will inevitably increase the demand for instruments by the vast number of pharmaceutical companies and drug testing institutions. Tianjin Hengao Technology Development Co., Ltd. has a variety of instruments to facilitate the effective implementation of the new pharmacopoeia. .

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