The past decades have seen a massive increase in the requirements of GMP, and this is reflected in recruitment, especially in laboratory quality control. Very often, within the department, candidates have been selected for their expertise in BPM and the attitude to analytical chemistry skills.
The quality control requirements typical analytical chemist to understand the tests, and therefore be able to solve any problem, which often does not equal the external pressure and possible economic repercussions without an analytical problem solving can cause.
This book is intended to aid the chemical quality control, but also in general to make the knowledge about these tests accessible to scholars and technicians working with these tests. It is organized into two parts dealing with the evidence of the European Pharmacopoeia 2.3.1 and 2.4, identification and limit tests, respectively. Each part contains three general chapters on issues relevant to the identification of all the pharmacopoeia / limit tests are discussed, then the individual tests are described and analyzed in sections organized and named in the European Pharmacopoeia. The test sections start with some brief remarks about the purpose and rationale of the tests, followed by a review of physical and chemical characters of the ions or compound that is the objective of the test. Then, the chemical substance and logic of individual steps of the test procedure are described with formulas and reactions, including comments on the strengths and weaknesses in terms of specificity, ruggedness, and potential procedural difficulties. All chapters include a list of references that could be the starting point for further research.
Many of the monographs in the European Pharmacopiea, the industry standard of proof for certain groups of ingredients and excipients, they do not describe the evidence as a whole, but the reference methods based on general chemistry test tube. When a test fails, you need to know what went wrong, how can it be fixed, and how to convince QA \ QC material tested is fine. This gives little time to dig the relevant scientific literature, literature that is often so old that does not appear in an electronic search.
That this knowledge easily accessible and directly applicable to work in the laboratory of Pharmaceutical Chemical Analysis: Methods for limiting identifications tests and explains the purpose of these older tests, the chemistry involved, and hazards to avoid. The book covers the identification of ions and functional groups of tests and limit tests, respectively. It covers topics relevant to the identification of all the pharmacopoeia / limit test, and then goes on to describe the individual tests in chapters organized and named as they appear in the European Pharmacopoeia. Each chapter begins with a brief discussion about the purpose and rationale of the tests, followed by a review of physical and chemical characters of the target ion or compound. The author describes the chemical background and logic of individual steps of the test procedure and the reaction formulas and offers tips on the strengths and weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural difficulties.
The strict regulatory requirements and economic pressures that the pharmaceutical industry, understandably reluctant to replace a test that is simple, inexpensive, and works well with expensive, non-validated instrument techniques. This resource bridges the gap by providing a thorough knowledge of the principles behind the European Pharmacopoeia tests and how to use, saving valuable production time.
The quality control requirements typical analytical chemist to understand the tests, and therefore be able to solve any problem, which often does not equal the external pressure and possible economic repercussions without an analytical problem solving can cause.
This book is intended to aid the chemical quality control, but also in general to make the knowledge about these tests accessible to scholars and technicians working with these tests. It is organized into two parts dealing with the evidence of the European Pharmacopoeia 2.3.1 and 2.4, identification and limit tests, respectively. Each part contains three general chapters on issues relevant to the identification of all the pharmacopoeia / limit tests are discussed, then the individual tests are described and analyzed in sections organized and named in the European Pharmacopoeia. The test sections start with some brief remarks about the purpose and rationale of the tests, followed by a review of physical and chemical characters of the ions or compound that is the objective of the test. Then, the chemical substance and logic of individual steps of the test procedure are described with formulas and reactions, including comments on the strengths and weaknesses in terms of specificity, ruggedness, and potential procedural difficulties. All chapters include a list of references that could be the starting point for further research.
Many of the monographs in the European Pharmacopiea, the industry standard of proof for certain groups of ingredients and excipients, they do not describe the evidence as a whole, but the reference methods based on general chemistry test tube. When a test fails, you need to know what went wrong, how can it be fixed, and how to convince QA \ QC material tested is fine. This gives little time to dig the relevant scientific literature, literature that is often so old that does not appear in an electronic search.That this knowledge easily accessible and directly applicable to work in the laboratory of Pharmaceutical Chemical Analysis: Methods for limiting identifications tests and explains the purpose of these older tests, the chemistry involved, and hazards to avoid. The book covers the identification of ions and functional groups of tests and limit tests, respectively. It covers topics relevant to the identification of all the pharmacopoeia / limit test, and then goes on to describe the individual tests in chapters organized and named as they appear in the European Pharmacopoeia. Each chapter begins with a brief discussion about the purpose and rationale of the tests, followed by a review of physical and chemical characters of the target ion or compound. The author describes the chemical background and logic of individual steps of the test procedure and the reaction formulas and offers tips on the strengths and weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural difficulties.
The strict regulatory requirements and economic pressures that the pharmaceutical industry, understandably reluctant to replace a test that is simple, inexpensive, and works well with expensive, non-validated instrument techniques. This resource bridges the gap by providing a thorough knowledge of the principles behind the European Pharmacopoeia tests and how to use, saving valuable production time.
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