Annex 2 Stability testing of active pharmaceutical ingredients and fi nished pharmaceutical products (original) (raw)
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STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENT [API
Stability plays an important role in drug development process. It explains several factors that affect the quality of a drug substance or drug products varies with time under the influence of environmental factors such as temperature, humidity and light. Stability studies play a vital role to decide the re-test period and shelf life for the drug substance and recommended storage conditions of API. ICH and EMEA guidelines define stability data package for new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan and United States.
A stability study is a routine procedure which ensures the maintenance of pharmaceutical product safety quality and efficacy throughout the shelf life. Stability studies at a developmental stage provides a data base that may be of value in selection adequate formulation to determine shelf life, container closure system and storage conditions for development of new product. In a stability study, the effects of variation in temperature, time, humidity, light intensity and partial vapor pressure on the pharmaceutical product are investigated. These pharmaceutical products are followed by the guidelines issued by International Conference on Harmonization (ICH), World Health Organization (WHO) or other agencies. This review presents the importance of stability testing for any pharmaceutical product. An important point in conducting stability studies are storage conditions which are derived from real climatic conditions. As stability study is tool in cGMP, indirectly to attribute quality product which will increase reputability of company in global market. In this review work we traced the point on recent trends in stability study, recent guidelines, climatic zones, sampling time and plan, estimation of self life, and some stability specifications for pharmaceutical products mentioned.
Stability of Pharmaceutical Products
Drug Stability and Chemical Kinetics, 2020
This chapter explains the concept of stability of pharmaceutical products as the extent to which they retain those properties and characteristics within the specified limits, throughout their period of storage and use, possessed at the time of their packaging. The terms like shelf-life and expiry are well defined here. The importance of stability of drug products describes the consequences of instabilities occurring in drug products. Types of stability mainly physical, chemical, microbiological, therapeutic, and toxicological stability have also been discussed concisely. Factors such as moisture, excipients, temperature, pH, oxygen, and light affect the efficacy, quality, and properties of drugs, which makes the drug either a toxic compound or a substance that has no or very little therapeutic activity. Instabilities among different pharmaceutical drug products and substances are explained along with the stability studies to evaluate their degradation behavior upon exposure to various parameters. Such parameters can be controlled according to the stability study type. The testing methods described in this chapter are real-time stability testing, accelerated stability testing, retained sample testing, and cyclic temperature stress testing along with their advantages and disadvantages. The standards for environmental conditions to be provided during such studies are set according to WHO and ICH guidelines. These studies play an important role during drug development stages and are considered as fundamental processes to be carried out for the approval and
STABILITY TESTING OF NEW PHARMACEUTICAL DRUG PRODUCTS
The ability of a specific pharmaceutical substance or product in a specific closed system (container), to remain stable or among its specifications of physical, therapeutic, chemical, microbiological parameters right through its shelf life, it is known as the stability. The stability studies is a vital parameter in every field including the pharmaceutical sciences for the manufacturing of new pharmaceutical drugs as well as new pharmaceutical formulations. The assumption of the shelf-life is vital for the manufacturing of a pharmaceutical product of all the dosage forms and also the stability testing is performed to determine the instructions and conditions for the label and storage of a specific pharmaceutical dosage form. For the manufacturing and acceptance of the pharmaceutical product i.e. the drug product or the API (Active Pharmaceutical Ingredient) i.e. the drug substance, stability testing are needed. For the acceptance and approval of pharmaceutical finished products, stability testing are necessary for confirming the products safety, quality and efficacy right through its shelf life. This review paper represents the stability parameter which is used for the analysis of new finished product. The stability testing are required to be performed in a planned manner as per the ICH (International Conference on Harmonisation), WHO (World Health Organization) or other regulatory bodies. The ICH guideline for performing the new pharmaceutical finished product’s stability testing are shown in this review paper. Keywords: Stability studies, pharmaceutical product, stability zones, ICH guideline, stability testing
Guidelines on Stability Studies of Pharmaceutical Products and Shelf Life Estimation
International Journal of Advances in Pharmacy and Biotechnology, 2020
The primary aim of carrying out stability studies of drug products is to determine the expiration date and to promise the product standardized for efficacy, safety and elegance throughout its shelf-life. ICH, WHO, ASEAN and separate agencies issued the guidelines for stability studies, which are requisite to be demeanour in a deliberate way and are wise as prerequisite for regulatory fill and approval of any medicinal product. Stability investigating provides the collection on stability strikingness of drug product including the belief of various environmental factors, packaging method etc. ensuring that it remain within planted specification to hold its degree and present the desirable performance consistently and in a way comforting for the usefulness of its intentional use all finished the retest or expiry date. This canvas types of stability studies, guidelines issue for stability investigation and forecasting of shelf life of medicine products along with flowing trends in stability studies.
Development of stability indicating studies for pharmaceutical products: an innovative step
A stability study is a routine procedure which ensures the maintenance of pharmaceutical product safety, quality and efficacy throughout the shelf life. These pharmaceutical products are followed by the guidelines issued by International Conference on Harmonization (ICH), World Health Organization (WHO) or other agencies. Stability testing provides evidence that the quality of a drug substance or drug product under the influence of various environmental factors changes with time. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review. This review article includes introduction about stability studies types of stability studies and chemical reactions takes place during degradation etc. This article also includes the forced degradation studies and shelf life estimation of pharmaceutical products.