Basic tests for pharmaceutical dosage forms.
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TextPublication details: Geneva : World Health Organization, 1991. Description: 129 pISBN: 924154418XTitle translated: Tests simplifiés pour les préparations pharmaceutiques; Pruebas básicas para formas farmacéuticasSubject(s): Pharmaceutical preparations -- analysis -- handbooks | Dosage forms -- standards | Quality control | Pharmaceuticals and BiologicalsNLM classification: QV 39Abstract: Sets out rapid screening tests required to verify the identity of some 150 pharmaceutical dosage forms in common use. The tests, which are simple and readily applicable, make it possible to confirm the identity of pharmaceutical substances in tablet, capsule, solution, lotion and other forms in those cases where quality is in doubt. The basic tests detailed in this book may also be applied to determine whether gross degradation has occurred despite high standards of packaging. The book opens with an outline of the essential equipment and laboratory services needed to carry out basic tests. Readers are also advised on what to look for during visual inspection for physical defects, and given detailed information on the procedures required for the determination of melting characteristics. The core of the book provides step-by-step instructions in the test procedures required to verify the identity of each formulation. The methods describe the use of a limited number of easily available reagents and equipment, and do not require a fully equipped laboratory. These are predominantly test-tube reactions which can be undertaken away from a laboratory - at a customs post or in a warehouse - by anyone with some understanding of analytical chemistry. The book concludes with an extensive list of reagents, test solutions, and volumetric solutions needed for testing dosage forms. Preparation procedures are also provided, in full detail, for those test solutions requiring special attention.
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Sets out rapid screening tests required to verify the identity of some 150 pharmaceutical dosage forms in common use. The tests, which are simple and readily applicable, make it possible to confirm the identity of pharmaceutical substances in tablet, capsule, solution, lotion and other forms in those cases where quality is in doubt. The basic tests detailed in this book may also be applied to determine whether gross degradation has occurred despite high standards of packaging. The book opens with an outline of the essential equipment and laboratory services needed to carry out basic tests. Readers are also advised on what to look for during visual inspection for physical defects, and given detailed information on the procedures required for the determination of melting characteristics. The core of the book provides step-by-step instructions in the test procedures required to verify the identity of each formulation. The methods describe the use of a limited number of easily available reagents and equipment, and do not require a fully equipped laboratory. These are predominantly test-tube reactions which can be undertaken away from a laboratory - at a customs post or in a warehouse - by anyone with some understanding of analytical chemistry. The book concludes with an extensive list of reagents, test solutions, and volumetric solutions needed for testing dosage forms. Preparation procedures are also provided, in full detail, for those test solutions requiring special attention.
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WHODOC
WHO monograph
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