The pharmaceutical industry is an important industry related to national economy and people's livelihood, and the quality and safety of medicines are also increasingly concerned by the public. The recent occurrence of poison capsules using industrial gelatin to manufacture medical capsules has raised the quality and safety of medicines to a height that has attracted everyone's attention. During the 12th Five-Year Plan period, the country clearly proposed to improve the quality and safety of medicines. The implementation of the new version of the "GMP" and the promulgation of the new version of the "Pharmacopoeia of the People's Republic of China" pointed out a clear direction for achieving this goal. In the recent poison capsule incident, the state has paid more attention to the inspection regulations of drugs, and the implementation of the new version of the Pharmacopoeia has been greatly increased.
The Shimadzu Company, which is committed to achieving human and global health, has completed the Chinese pharmaceutical industry standard "Pharmaceutical Production Quality Management Standards" and the 2010 "People's Republic of China Pharmacopoeia" in conjunction with the relevant standards of the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) A set of comprehensive testing methods in the field of medicine. The application data set relies on the advantages of Shimadzu's long product line and complete range of analytical instruments. Through the development of multiple models such as AA, ICP, TOC, FTIR, TA, SALD, etc., the pharmaceutical industry has completed chemical medicine, traditional Chinese medicine, medicine Comprehensive analysis and testing methods for auxiliary materials, medical device materials and pharmaceutical packaging materials. The testing content includes heavy metals, organic content, drug identification, material properties, etc.
"Shimadzu Spectroscopy Applications in the Medical Field" includes a preface, preface, application data, and consists of three parts. The application data includes 16 application reports, including 5 AA, 3 ICP, 3 TOC, 2 FTIR, 1 FTIR and DSC coordinated test, 1 TA, and 1 SALD.
The application method is as follows:
1 Shimadzu AA7000 determination of cosolvent sodium carbonate in ceftazidime for injection
2 Determination of mercury in Chinese herbal medicines by cold vapor atomic absorption method
3 Determination of potassium in compound sodium chloride by atomic absorption flame emission
4 Determination of tin, arsenic and cadmium in polylactic acid by graphite furnace atomic absorption method
5 Microwave digestion graphite furnace atomic absorption method for the determination of chromium in hollow capsules
6 ICP-AES determination of heavy metal elements in three Chinese herbal medicines
7 ICP-AES determination of residual metal catalyst in valacyclovir hydrochloride
8 Microwave digestion ICP-AES determination of palladium in palladium-carbon catalyst
9 Cleaning effectiveness certification of pharmaceutical equipment
10 U.S. Pharmacopeia system suitability test and water for injection testing
11 Shimadzu TOC-V WP detection of total organic carbon in pharmaceutical water
12 Use the drug reporting program to quickly identify drugs
13 Fourier Transform Infrared Spectrometer Qualitative Analysis of Multilayer Films in Medical Packaging Materials
14 Use FTIR and DSC to deal with the quality inspection of FDA drug packaging materials
15 DSC analysis of crystallinity of special medical tubing
16 Application of dry laser particle size in the pharmaceutical industry
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