impurity and stability studies m pharmacy.pptx

impurity and stability studies m pharmacy

1. Impurity and Stability Studies in Pharmaceuticals Ensuring Drug Purity, Safety, and Efficacy

2. Introduction Importance of drug purity and stability in pharmaceuticalsOverview of regulatory requirements (ICH, FDA, WHO, etc.)

3. Impurities in Pharmaceuticals Definition: Any unwanted substance present in the drug productSources of Impurities:Starting materials & raw materialsBy-products of synthesisDegradation productsResidual solventsExcipients interaction

4. Types of Impurities Organic Impurities (Process-related & degradation products)Inorganic Impurities (Reagents, catalysts, heavy metals)Residual Solvents (Organic and inorganic volatile impurities)

5. Impurity Profiling & Analytical Techniques Impurity Profiling: Identifying, quantifying, and controlling impuritiesAnalytical Techniques Used:Chromatography: HPLC, GCSpectroscopy: UV, IR, NMR, Mass SpectrometryElemental Analysis: ICP-MS, AAS

6. Regulatory Guidelines for Impurities ICH Q3A (R2): Impurities in new drug substancesICH Q3B (R2): Impurities in new drug productsICH Q3C: Residual solventsICH Q3D: Elemental impurities

7. Stability Studies - Introduction Definition: Study of a drug’s physical, chemical, and microbiological stability over timePurpose:To determine shelf lifeTo establish storage conditionsTo identify degradation pathways

8. Types of Stability Studies Long-term stability studies (Real-time conditions)Accelerated stability studies (High temperature/humidity)Intermediate stability studies (Between long-term & accelerated)Forced degradation studies (Stress testing to determine degradation pathways)

9. Stability Testing Conditions (ICH Q1A-R2) Long-term: 25°C ± 2°C / 60% RH ± 5% RH (12-60 months)Accelerated: 40°C ± 2°C / 75% RH ± 5% RH (6 months)Intermediate: 30°C ± 2°C / 65% RH ± 5% RH (12 months)

10. Stability-Indicating Analytical Methods Detects changes in API and degradation productsKey Analytical Techniques:HPLCLC-MSFTIRUV Spectroscopy

11. Factors Affecting Stability Environmental Factors: Temperature, humidity, lightFormulation Factors: Excipients, pH, particle sizePackaging Materials: Glass vs. Plastic, moisture permeability

12. Regulatory Guidelines for Stability Studies ICH Q1A (R2): Stability testing of new drug substances and productsICH Q1B: Photostability testingICH Q1D: Bracketing and matrixing design for stability