Impurities_in_Pharmaceutical_Substances_with_WebImage_Links.pptx

B pharm 1st year

1. Impurities in Pharmaceutical Substances Unit I — Detailed Overview

2. Introduction Pharmaceutical substances must be pure to ensure safety and efficacy. Impurities may arise during manufacturing, storage, or handling. This unit covers types, sources, and tests for impurities. Pharmacopoeia Logo/History Suggested images (click links to open): Pharmacopoeia image (Wellcome): https://commons.wikimedia.org/wiki/File:The_pharmacopoeia_Wellcome_L0028638.jpg Pharmacopoeia title page (1826): https://commons.wikimedia.org/wiki/File:Title_page_of_The_Pharmacopoeia%2C_1826._Wellcome_M0012586.jpg

3. History of Pharmacopoeia - Early pharmacopoeias were local drug references. - Modern pharmacopoeias: IP, BP, USP. - Provide drug purity standards and impurity limits. Sources of Impurities Diagram Suggested images (click links to open): Sources of impurity (ResearchGate): https://www.researchgate.net/figure/Sources-of-impurity_fig1_281207406 Types & Sources diagram (ResearchGate): https://www.researchgate.net/figure/Types-of-Impurities-and-Sources_fig1_318119104

4. Sources of Impurities 1. Raw materials 2. Manufacturing process 3. Storage conditions 4. Contamination from equipment 5. Decomposition products Types of Impurities Flow Suggested images (click links to open): Types of impurities diagram (Slideshare): https://www.slideshare.net/slideshow/sources-of-impurities/249860534 Impurity review (PMC): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3255420/

5. Types of Impurities - Organic impurities (starting materials, by-products) - Inorganic impurities (reagents, catalysts, heavy metals) - Residual solvents - Degradation products

6. Principle of Limit Tests - Semi-quantitative tests for impurities. - Detect impurities at permissible levels. - Based on comparison with a standard solution. Limit Test Setup (Chloride/Sulphate) Suggested images (click links to open): Halides test with AgNO3 (Wikimedia Commons): https://commons.wikimedia.org/wiki/File:Halides_%28I-,_Br-,_Cl-_%29_test_with_AgNO3.jpg Barium sulfate images (Wikimedia Commons): https://commons.wikimedia.org/wiki/File:Barium_sulfat_3D.png

7. Limit Test for Chloride - Principle: Chlorides form turbidity with AgNO3. - Compared with standard NaCl solution. - Ensures chloride is below toxic level. Iron Limit Test (Color Change) Suggested images (click links to open): Aqueous ferric thiocyanate (Wikimedia Commons): https://commons.wikimedia.org/wiki/File:Aqueous_ferric_thiocyanate_%28Fe%28SCN%29n%29_hydrate_mix.jpg Iron(III)-thiocyanate background (ACS Molecule of the Week): https://www.acs.org/content/acs/en/molecule-of-the-week/archive/i/iron-thiocyanate.html

8. Limit Test for Sulphate - Principle: Sulphates form turbidity with BaCl2. - Standard K2SO4 solution used for comparison. Arsenic Test Apparatus Suggested images (click links to open): Gutzeit apparatus (Science Museum Group): https://collection.sciencemuseumgroup.org.uk/objects/co13507/gutzeit-apparatus-for-determining-arsenic Limit test for arsenic (LearnAboutPharma): https://learnaboutpharma.com/limit-test-for-arsenic-principle-gutzeit-apparatus-procedure-and-notes/

9. Limit Test for Iron - Principle: Iron forms red color with thioglycolic acid or ammonium thiocyanate. - Compared with standard ferric solution. Lead/Heavy Metals Test Setup Suggested images (click links to open): Lead - Dithizone complex (Wikimedia Commons): https://commons.wikimedia.org/wiki/File:Lead_Dithizone.svg Dithizone images (Wikimedia Commons category): https://commons.wikimedia.org/wiki/Category:Dithizon

10. Limit Test for Arsenic - Principle: Arsenic forms yellow/brown stain on mercuric paper. - Gutzeit test commonly used.

11. Limit Test for Lead - Principle: Lead forms color complex with dithizone. - Compared with standard lead solution.

12. Limit Test for Heavy Metals - Principle: Metals react with sulfide ions forming colored precipitates. - Compared visually with standard.

13. Modified Limit Tests - For Chloride: Modified by pH control and better visual comparison. - For Sulphate: Modified by stabilizing agents for better sensitivity. Flowchart Illustration Suggested images (click links to open): Impurities overview PPT (Slideshare): https://www.slideshare.net/slideshow/impurities-in-pharmaceutical-substances-249550078 Sources of impurities PDF (Courseware): https://courseware.cutm.ac.in/wp-content/uploads/2020/06/Sources-of-Impurities-.pdf

14. Conclusion - Impurities must be controlled for drug safety. - Pharmacopoeial standards ensure quality. - Limit tests are simple yet effective methods.

15. Flowchart: Handling of Impurities Raw Material → Manufacturing → Storage → Contamination → Decomposition → Impurity Control (Limit Tests)

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