scholarly journals Nonspecific Impurities in Pharmaceutical Substances: Characteristics of Test Methods

2019 ◽  
Vol 9 (3) ◽  
pp. 153-161
Author(s):  
Yu. R. Biglova ◽  
N. V. Gadasina ◽  
T. N. Bokovikova ◽  
E. L. Kovaleva ◽  
S. A. Nemykina ◽  
...  
Keyword(s):  
Methodological Approach ◽  
Pharmaceutical Products ◽  
Test Methods ◽  
Emission Spectrometry ◽  
Trace Impurities ◽  
Specific Test ◽  
Pharmaceutical Substances ◽  
Biological Tests

One of the prerequisites of efficacy and safety of finished pharmaceutical products is the quality of pharmaceutical substances used in their production. Criteria of assessment of pharmaceutical substance purity are determined by the substance composition and production technology, as well as by specific aspects of the finished pharmaceutical product production and use. It is necessary to control the content of nonspecific organic and inorganic impurities, impurities of microbial origin, and residual solvents. The aim of the study was to analyse characteristics of test methods used to determine nonspecific impurities in pharmaceutical substances. The State Pharmacopoeia of the Russian Federation describes various chemical, physical, physicochemical and biological tests for the analysis of nonspecific impurities. Determination of inorganic cations and anions usually includes comparison of test solutions with solutions of the corresponding reference standards, or checking the absence of a positive reaction in the test solution. Quantitative analysis of trace impurities largely relies on highly specific and sensitive test methods, such as atomic absorption spectrometry, atomic emission spectrometry and inductively coupled plasma mass spectrometry. The content of residual organic solvents is determined by gas chromatography or high-performance liquid chromatography. The purity and safety of pharmaceutical substances are ensured by biological tests: “Microbial quality”, “Sterility”, “Pyrogenicity”, “Bacterial endotoxins”. Specific characteristics of test methods used for determination of the content of nonspecific impurities in various pharmaceutical substances depend on physicochemical properties of the tested substances, toxicity of the analysed impurities, and content limits. The results of the study make it possible to formulate a methodological approach to the development of criteria for assessing the quality of pharmaceutical substances. This approach includes mandatory compliance with the basic principles of substance standardisation, as well as case-by-case selection of quality parameters, specific test conditions and content limits for impurities.

Direct determination of trace impurities in high-purity silicon nitride by axial viewed inductively coupled plasma optical emission spectrometry using a slurry nebulization technique

2015 ◽  
Vol 30 (4) ◽  
pp. 909-915 ◽  
Author(s):  
Zheng Wang ◽  
Junye Zhang ◽  
Guoxia Zhang ◽  
Deren Qiu ◽  
Pengyuan Yang
Keyword(s):  
Silicon Nitride ◽  
High Purity ◽  
Inductively Coupled Plasma ◽  
Direct Determination ◽  
Optical Emission ◽  
Emission Spectrometry ◽  
Trace Impurities ◽  
High Purity Silicon ◽  
Slurry Nebulization

A simple, rapid and reliable method was developed for the determination of trace impurities in high-purity silicon nitride (nm- and μm-sized) by ICP-OES using a slurry nebulization technique.

scholarly journals PENINGKATAN MUTU UJIAN DARI PAPER BASED MENUJU COMPUTER BASED

CCIT Journal ◽  
2012 ◽  
Vol 5 (3) ◽  
pp. 302-311
Author(s):  
Ferry Sudarto ◽  
Hidayati Hidayati ◽  
Ageng Setiani Rafika
Keyword(s):  
Higher Education ◽  
Learning Process ◽  
High Standard ◽  
Test Methods ◽  
Innovative Technology ◽  
Limit Value ◽  
Computer Based ◽  
Exam System

Adoption of the exam objectives in a learning process is to determine the quality of one’s learner after going through the learning process. Exams are also an evaluation of the monitoring process carried out continuously and sustainably will ultimately be able to fix the quality of education. Determination of the ever-increasing standards expected to encourage the improvement of education quality, which is the determination of educational standards is the determination of the limit value (passing score). Someone said to have passed / are competent when it has passed the limit value. In the world of Education in Higher Education Raharja for example, in order to obtain the concentration Communication and Innovative Technology (CCIT) who have exam system that v used Cisco Certified Network Associate (CCNA) Benchmarking the learning standards. But it was not as easy as expected, due to problems regarding the exams are still using paper based are not inaccordance with the standard CCNA Benchmarking using computer-based exam. Benchmarking standard exam is CCNA is a computer based exam where students can do the exam questions on a computer that random such questions, which makes each student can work on the problems at the same time but each working on different problems. In the matter of computer-based working time limits there are also questions it. In Higher Education Raharja, test is still manual (paper based) where the students are still working on the exam questions and answers contained in the paper. The concept paper based is much less effective,can not even detect students who work together when the exam. At present it has developed a new method is more effective and certainly the most can help overcome these problems. Example for computer Based exam is CCNA exam and The Test of English as a Foreign Language (TOEFL) computer based and Raharja high-standard universities. In this article also identified at least four fundamental problems concerning the concept of computerbased exam, defining test methods based computer as a new way of tackling paper based exam, and final test of is to implement a computer based on the Higher Education Raharja. Computer-based methods is very important to be developed, because its function is effective in providing quality improvement exam in Higher Education Raharja thus continues to provide ease in doing the exam students and faculty in terms of giving value to students. In addition, computer-based exam process is also well suited to the needs. It can even be said that the computer based exams can erode the operational work of approximately 80% of original work not to perform the correction process answers all students who did a paperbased exam.

Methodology of Research Concerning Micropollutants: Biological Tests

1982 ◽  
Vol 14 (12) ◽  
pp. 143-152 ◽  
Author(s):  
C L M Poels ◽  
M A van der Gaag ◽  
A Noordsij
Keyword(s):  
Biological Effects ◽  
Test Methods ◽  
Polluted Water ◽  
Fully Integrated ◽  
Low Concentrations ◽  
Wide Variability ◽  
Biological Tests ◽  
Biological Methods ◽  
Near Future

To obtain insight into the toxicological quality of polluted waters a broad range of test methods is available. Because of the wide variability in biological effects caused by the substances present in a complex polluted water, a well considered choice of biological methods is recommended. These biological methods should be supported by, and if possible strongly integrated with, chemical analysis. For detection of harmful effects of water containing numerous pollutants in low concentrations, longterm as well as embryo/larval tests with rainbow trout are applied to measure chronic toxic effects. The very important genotoxic effects however are missed by these tests. For this purpose Sister-Chromatid exchange tests with eastern mud-minnows and Amestests are performed. Especially the last test can be fully integrated with analytical chemical methods. Thereby it will be possible in the near future to identify the mutagenic substances and to track down their origin.

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