The shelf life of l-alanyl-l-tyrosine is affected by various factors, and its shelf life varies under different pharmaceutical manufacturing processes. The following are some common situations:
I. Traditional Pharmaceutical Manufacturing Process
Common Synthesis and Crystallization Process: Using conventional chemical synthesis methods and then purifying through simple crystallization techniques. Under this process, if the packaging and storage conditions are average, the product may have a shelf life of 1-2 years at room temperature. This is because during the common synthesis process, some impurities may remain, and these impurities may trigger side reactions during storage, affecting the product's stability. At the same time, the simple crystallization process may not be able to obtain an ideal crystal form, making the product prone to crystal form transformation during storage, thus affecting its quality and shelf life.
Conventional Drying and Packaging Process: During the drying process, if common hot air drying and other methods are used, the product may be overheated, resulting in damage to some active ingredients. Moreover, ordinary packaging materials and the packaging environment have limited protective effects on the product. In this case, the shelf life of the product may be extended to 2-3 years under refrigeration conditions (2-8°C).
II. Optimized Pharmaceutical Manufacturing Process
Improved Synthesis and Purification Process: By optimizing the synthesis reaction conditions, such as precisely controlling the temperature, pH value, and reaction time, the occurrence of side reactions can be reduced, and the product purity can be improved. At the same time, advanced purification technologies, such as high-performance liquid chromatography purification, can effectively remove impurities. The l-alanyl-l-tyrosine produced using this process may have a shelf life of 2-3 years at room temperature. This is because the high-purity product reduces the degradation reactions caused by impurities and has higher stability.
Precise Crystal Form Control and Special Packaging Process: Utilize precise crystal form control technology to obtain a crystal form with good stability. And use packaging materials with good barrier properties, such as multi-layer composite aluminum foil packaging, and adopt protective measures such as nitrogen filling during the packaging process. In this case, the shelf life of the product under refrigeration conditions may be extended to 3-5 years.
The above data are only approximate ranges, and the actual shelf life needs to be determined through strict stability tests and quality inspections. The specific process parameters and production conditions of different enterprises are different, and the shelf life of the products will also vary.
