9786139917419 - Stress Degradation Studies and Stability-Indicating Analytical Methods: Stress Degradation Studies, Stability-Indicating Assay Methods, HPLC, HPTLC Analysis, Impuri... (8 risultati)

Condizione: New.

Taschenbuch. Condizione: Neu. Stress Degradation Studies and Stability-Indicating Analytical Methods | Stress Degradation Studies, Stability-Indicating Assay Methods, HPLC, HPTLC Analysis, Impurities | Mirza Shahed Baig (u. a.) | Taschenbuch | 428 S. | Englisch | 2018 | LAP LAMBERT Academic Publishing | EAN 9786139917419 | Verantwortliche Person für die EU: BoD - Books on Demand, In de Tarpen 42, 22848 Norderstedt, info[at]bod[dot]de | Anbieter: preigu.

Condizione: New.

Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Quality of any Active Pharmaceutical Ingredient (API) or drug product for patient compliance is directly depending on stability of drug. The ICH drug stability test guideline Q1A (R2) requires that analysis of stability samples should be done through the use of validated Stability indicating assay methods (SIAMs) that can detect the changes with time in the chemical, physical, or microbiological properties of the drug substance and drug product, and that are specific, so that the contents of active ingredient, degradation products, and other components of interest can be accurately measured without interference. A proactive approach in developing a SIAMs involve forced degradation at the early stages of development with the key degradation samples used in the method development process. 428 pp. Englisch.

Taschenbuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware -Quality of any Active Pharmaceutical Ingredient (API) or drug product for patient compliance is directly depending on stability of drug. The ICH drug stability test guideline Q1A (R2) requires that analysis of stability samples should be done through the use of validated Stability indicating assay methods (SIAMs) that can detect the changes with time in the chemical, physical, or microbiological properties of the drug substance and drug product, and that are specific, so that the contents of active ingredient, degradation products, and other components of interest can be accurately measured without interference. A proactive approach in developing a SIAMs involve forced degradation at the early stages of development with the key degradation samples used in the method development process.VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 428 pp. Englisch.

Taschenbuch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Quality of any Active Pharmaceutical Ingredient (API) or drug product for patient compliance is directly depending on stability of drug. The ICH drug stability test guideline Q1A (R2) requires that analysis of stability samples should be done through the use of validated Stability indicating assay methods (SIAMs) that can detect the changes with time in the chemical, physical, or microbiological properties of the drug substance and drug product, and that are specific, so that the contents of active ingredient, degradation products, and other components of interest can be accurately measured without interference. A proactive approach in developing a SIAMs involve forced degradation at the early stages of development with the key degradation samples used in the method development process.

Condizione: New. Print on Demand.

Condizione: New. PRINT ON DEMAND.