Downloaded 35 times
Uploaded byphcognosy
stability testing
This document discusses stability testing of herbal drugs. Stability is defined as the capacity of a drug to remain within established specifications limits to maintain its identity, quality and purity throughout its retest or expiration period. Stability testing helps determine a product's shelf life and suitable formulations, excipients, and packaging. It ensures product quality and safety for patients. Types of stability studies include physical, chemical, microbiological, and therapeutic stability testing. The document outlines specifications criteria, testing methods like real-time and accelerated testing, protocols, recommended tests for different dosage forms, and factors affecting stability of herbal medicines like physical and chemical instability, complexity, and drug interactions.
More Related Content
Similar to stability testing
stability testing
- 1. Stability Testing ofHerbal Drugs S.Selvadurai.,M.Pharm.,MBA., Associate Professor Department of Pharmacognosy
- 3. What is Stability? โthecapacity of a drug to remain within established speifications limits to maintain its identity, quality & purity throughout the retest or expiration dating periodsโ
- 4. CONCEPT OF STABILITY Stabilityis the capacity of a specific formulation in a particular container/closure system to remain within its prescribed limits like Physical Chemical Microbiological Therapeutic Specifications
- 5. ADVANTAGES ๏ถHelp in determinationof shelf life and storage conditions. ๏ถHelp in selection of suitable formulation, excipients and container closure systems for a product. ๏ถWell being of the patient and manufacture by ensuring the good product quality. ๏ถEnhance patient confidence in herbal drugs and improve compliance.
- 6. TYPES OF STABILITYSTUDY AS PER USP S.No Type of Stability Condition to be maintained throughout the shelf life of drug product 01 Physical The original physical properties, namely, appearance, uniformity, dissolution & suspendability are maintained. 02 Chemical Each & Every active ingredient retains its chemical integrity as well as potency specified on lable, within the specified limits. 03 Microbiological Sterility or resistance to microbial growth is maintained as per the specified requirements 04 Therapeutic The therapeutic effect remains unaltered 05 Toxicological No valid increase in toxicity occurs
- 7. SPECIFICATIONS CRITERIA FORHERBAL DRUGS Specifications Botanical Characters Macro, Micro, Phyto, toxic constituents Biological/Geogr aphical Pre/Post harvest chemical treatments Profile & stability of the constituents
- 8. DIFFERENT STABILITY TESTINGMETHOD Real time testing Accelerated testing Intermediate testing Stress testing Forced degradation testing 01 02 03 04 05
- 9. PROTOCOL FOR STABILITYTESTING 01 โข Selection of bacterial and samples 02 โข Test Selection 03 โข Analytical Procedure 04 โข Acceptance Criteria 05 โข Storage Conditions 06 โข Testing frequency 07 โข Storage period 08 โข Sampling Plan 09 โข Container closure system 10 โข Evaluation 11 โข Statement, Labeling
- 10. RECOMMENDED STABILITY TESTFOR DIFFERENT HERBAL DOSAGE FORMS ACCORDING TO WHO 01 Decoctions, glycerites, aceterites, Oxymels Changing in Colour, Odour, taste, clarity, Specific gravity, pH, Viscosity etc.. 02 Tablets Changing in Color, pH, hardness, friability, swelling, Microbial contamination etc
- 11. 03 Capsules Change inColour, pH, total extractive, brittleness, hardening or softening of shell, etcโฆ 04 Alcoholic beverages, tinctures Extracts Clarity, pH, Specific gravity, alcohol content, total solid residue etc.,
- 12. 05 Teas & powders Change inOdour, Moisture content, pH, total water extractive, formation of hard mass, etc.. 06 Ointments & Balms Change in color,odour, homogeneity, pH, consistency, grittiness etc..
- 13. 07 Oils Rancidity, Change incolor, odour, pH, microbial contamination and toxicity. 08 Pastes & creams Change in color, odour, homogeneity, pH, Consistency,Phytochemic al constituents etcโฆ
- 14. 09 Soaps Chang incolor, odour, homogeneity, pH, toxicity/skin sensitivity tests. 10 Suppositories Softening, hardening, or drying, dissolution
- 15. FACTORS AFFECTING STABILITYOF NATURAL MEDICINES
- 16. ISSUES RELATED TOSTABILITY OF HERBAL DRUGS Issues related to stability of herbal drugs Physical Instability Processing Environment Chemical Instability Complexity Drug Interactions