There is a close relationship between drug expiration dates and influencing factors. Below is a structured analysis of key influencing factors and their mechanisms:
I. Core Influencing Factors and Their Mechanisms
Chemical Stability
Active ingredients are prone to hydrolysis, oxidation, and other reactions, with degradation products potentially reducing efficacy or causing toxicity. For example, biological products (such as insulin) are susceptible to denaturation and failure at high temperatures.
Physical Stability
Dosage form design (e.g., sustained-release tablets, enteric-coated tablets) maintains efficacy by controlling the release rate. Breaking or damaging the dosage form may lead to burst release or failure.
Storage Conditions
Temperature: High temperatures accelerate decomposition (e.g., nitroglycerin requires refrigeration away from light, stored at 15-25℃).
Humidity: Damp environments can cause mold (e.g., traditional Chinese medicines require sealed storage).
Light: UV light degrades photosensitive components (e.g., vitamin-based medications should be stored away from light).
Packaging and Transportation
Poorly sealed packaging can lead to oxidation or moisture absorption.
Severe vibrations during transportation may compromise physical stability.
II. Expiration Date Determination and Risk Thresholds
Unopened Medications: If stored properly, expiration within six months typically does not affect efficacy (e.g., bottled medications should be used within six months after opening).
Special Medications: Insulin requires different storage conditions (unopened: refrigerated; opened: room temperature for up to four weeks).
III. Industry Standards and User Recommendations
Standard Reference: Specifications like GB/T 36187-2018 clarify testing processes and storage requirements.
Practical Advice: Regularly inspect medications for changes (e.g., discoloration, clumping) and strictly follow storage instructions.
ST301 Drug Stability test chamber is used in the pharmaceutical industry for drug stability testing to determine the drug's shelf life and influencing factors. The biggest advantages of this series of products include ensuring stable and reliable testing results, precise temperature and humidity conditions, and an ultra long service life. The product meets the long-term, accelerated, and intermediate tests specified in the national pharmacopoeia, FDA, ICH, and other relevant standards, as well as the low humidity test at 40 ° C and 20% R.H for special drugs such as intravenous infusion.
Your message must be between 20-3,000 characters!