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Quality Assurance Chemist | QMS & Validation | IPQA activities

LVP stands for Large Volume Parenterals, which are sterile solutions intended for intravenous administration in a volume of more than 100 mL. According to the International Council for Harmonisation (ICH) Q1F guidelines on Stability Testing of Pharmaceutical Products and the World Health Organization Technical Report Series (WHO-TRS) recommendations, the recommended storage conditions for LVPs are: Long-term storage: 25°C ± 2°C / 60% RH ± 5% RH or 30°C ± 2°C / 65% RH ± 5% RH.expand_more Accelerated storage: 40°C ± 2°C / 75% RH ± 5% RH. These conditions are based on climatic zones.exclamation Zone I/II countries, which have temperate climates, typically use 25°C/60% RH for long-term storage. Zone III/IV countries, which have hot and humid climates, typically use 30°C/65% RH for long-term storage. Here's a table summarizing the storage conditions: Storage Condition Tm (°C) RH (% RH) Zone Long-term 25 ± 2 60 ± 5 I/II Long-term 30 ± 2 65 ± 5 III/IV Accelerated 40 ± 2 75 ± 5 All It's important to note that these are just general recommendations. The specific storage conditions for a particular LVP will depend on the product itself and the results of stability testing. Manufacturers are required to conduct stability studies to determine the appropriate storage conditions for their products. These stability studies typically involve storing the LVP under a variety of conditions, including different temperatures and humidity levels, over a period of time. The product is then tested for its potency, sterility, and other important characteristics. The results of these studies are used to establish the shelf life of the product and the recommended storage conditions. #storage #stability #temperature #humidity #shelflife #qualityassurance

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