There is no fixed standard for the shelf life of l-alanyl-l-tyrosine in pharmaceutical manufacturing. It is usually affected by various factors and generally ranges from 2 to 3 years under reasonable storage conditions. The following are some factors influencing its shelf life:
Storage Conditions: l-alanyl-l-tyrosine should be stored in a cool, dry, and well-ventilated place, avoiding direct sunlight and high temperatures. If the storage temperature is too high or the humidity is too great, it may accelerate its degradation, cause moisture absorption and caking, or lead to microbial contamination, thus shortening the shelf life. For example, in an environment with a temperature exceeding 30°C and a relative humidity greater than 75%, its shelf life may be significantly shortened.
Packaging Form: The barrier performance of the packaging material has an important impact on its shelf life. Using packaging with good sealing performance that can effectively block air and moisture, such as aluminum foil bags, glass bottles, etc., and filling with inert gases (such as nitrogen) can reduce the contact of the drug with oxygen and moisture and extend the shelf life. If the packaging is damaged or not tightly sealed, the drug is easily affected by external environmental factors, leading to deterioration and shortening of the shelf life.
Formulation Process and Excipients: During the pharmaceutical manufacturing process, the formulation process and the added excipients will also affect the stability and shelf life of l-alanyl-l-tyrosine. For example, selecting appropriate excipients such as antioxidants and stabilizers can improve the stability of the drug and extend the shelf life. On the other hand, an unreasonable formulation process may cause the drug to be damaged during the processing, reducing its stability and shortening the shelf life.
Quality of the Active Pharmaceutical Ingredient (API): The initial quality of l-alanyl-l-tyrosine is directly related to its shelf life in pharmaceutical manufacturing. If the API has high purity, low impurity content, and strict quality control during the production process, then after being made into a drug product, its shelf life is relatively long. Conversely, if the quality of the API is poor, containing more impurities or being contaminated during the production process, it may affect the stability of the drug and shorten the shelf life.
In actual production and use, pharmaceutical companies usually determine the shelf life of l-alanyl-l-tyrosine in specific formulations through stability tests. Stability tests include stress testing, accelerated testing, and long-term testing, etc. By conducting these tests to examine the quality changes of the drug under different conditions, a reasonable shelf life can be formulated.
