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Pharmaceutical chemistry. Drugs -- Analysis. Drugs -- Standards. Pharmaceutical Preparations -- analysis -- Laboratory Manuals. Pharmaceutical Preparations -- standards -- Laboratory Manuals.
Drug Compounding -- standards -- Laboratory Manuals. Quality Control -- Laboratory Manuals. Reference Standards -- Laboratory Manuals. Linked Data More info about Linked Data. Resources to the following titles can be found at www.
What are VitalSource eBooks? For Instructors Request Inspection Copy. Many of the monographs in the European Pharmacopiea , the industry standard test for certain groups of ingredients and excipients, do not describe the tests in full, but reference general methods based on test-tube chemistry. Making this knowledge easily accessible and directly applicable to work in the lab, Pharmaceutical Chemical Analysis: Methods for Limit Tests and Identifications explains the purpose of these older tests, the chemistry involved, and hazards to avoid.
The book covers the identification of ions and functional groups tests and limit tests respectively. Each chapter begins with a short discussion on the purpose and rationale of the tests, followed by a review of the physical and chemical characters of the target ion or compound. The author describes the chemical background and logic of the individual procedural steps of the test with formulas and reaction and provides tips on the strengths and weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural pitfalls. Strict regulatory requirements and economic pressures make the pharmaceutical industry understandably reluctant to replace a test that is simple, cheap, and performs well with expensive, unvalidated instrumental techniques.
This resource bridges the gap by providing an in-depth understanding of the principles behind the European Pharmacopoeia tests and how to use them, saving you valuable production time. Precipitations in Identifications. Color reactions in identifications. Acetates European Pharmacopoeia 2.
Method Development and Method Validation
Acetyl European Pharmacopoeia 2. Alkaloids European Pharmacopoeia 2. Aluminium European Pharmacopoeia 2.
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- The development and validation of methods of analysis for quality control.
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Amines, primary aromatic European Pharmacopoeia 2. Ammonium salts European Pharmacopoeia 2. Ammonium salts and salts of volatile bases European Pharmacopoeia 2. Antimony European Pharmacopoeia 2. Arsenic European Pharmacopoeia 2. Barbiturates, non—nitrogen substituted European Pharmacopoeia 2.
Benzoates European Pharmacopoeia 2. Bismuth European Pharmacopoeia 2. Bromides European Pharmacopoeia 2. Calcium European Pharmacopoeia 2.
Carbonates and bicarbonates European Pharmacopoeia 2. Chlorides European Pharmacopoeia 2. The burden of an individual analyst originating AQC efforts can be lessened through the implementation of quality assurance programs. Through the implementation of established and routine quality assurance programs, two primary functions are fulfilled: the determination of quality, and the control of quality.
Pharmaceutical Chemical Analysis: Methods for Identification and Limit Tests
By monitoring the accuracy and precision of results, the quality assurance program should increase confidence in the reliability of the reported analytical results, thereby achieving adequate AQC. Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a particular purpose. In cases such as changes in synthesis of the drug substance, changes in composition of the finished product, and changes in the analytical procedure, revalidation is necessary to ensure quality control.
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. Both tests should accurately measure the purity of the sample. Quantitative tests of either the active moiety or other components of a sample can be conducted through assay procedures.
Other analytical procedures such as dissolution testing or particle size determination may also need to be validated and are equally important.