Quality Of Pharmaceutical Products Research Articles

Optimizing MEP Design in Pharmaceutical Cleanroom with the Integration of 2D To 7D in BIM

Abstract: This paper examines the optimization of pharmaceutical cleanroom design using 2D to 7D Modelling in Building Information Modelling (BIM). The goal is to enhance the reliability, different methods, statistical data, and performance of pharmaceutical production plants by effectively allocating components within design constraints. Mathematical optimization techniques improve facility design, ensuring robustness and operational efficiency. The study proposes a reliable optimal design for air-conditioning systems in pharmaceutical cleanrooms, considering uncertainties in design parameters and operational strategies. Resilient cleanroom systems are developed, and adaptable to various conditions while maintaining high performance standards. Additionally, the research explores the application of experimental design methodologies in optimizing drug delivery systems, such as factorial and etc, to enhance the quality and efficiency of pharmaceutical products and processes.

Quality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countries

Malaria and Human Immunodeficiency Virus infections are among the top 10 causes of death in low income countries. Furthermore, many medicines used in these treatment areas are substandard, which contributes to the high death rate. Using a monitoring system to identify substandard and falsified medicines, the study aims to evaluate the quality of antimalarial and antiretroviral medicines in Sahel countries, assessing site conditions, compliance of medicines with pharmacopoeia tests, formulation equivalence with a reference medicine, and the influence of climate on quality attributes. Ultra Performance Liquid Chromatography methods for eight active pharmaceutical ingredients were validated following the International Conference for Harmonization guideline for its detection and quantification. Quality control consists of visual inspections to detect any misinformation or imperfections and pharmacopeial testing to determine the quality of pharmaceutical products. Medicines which complied with uniformity dosage units and dissolution tests were stored under accelerated conditions for 6 months. Artemether/Lumefantrine and Lopinavir/Ritonavir formulations failed uniformity dosage units and disintegration tests respectively, detecting a total of 28.6% substandard medicines. After 6 months stored under accelerated conditions (40 °C // 75% relative humidity) simulating climatic conditions in Sahel countries, some medicines failed pharmacopeia tests. It demonstrated the influence of these two factors in their quality attributes. This study emphasizes the need of certified quality control laboratories as well as the need for regulatory systems to maintain standards in pharmaceutical manufacturing and distribution in these countries, especially when medicines are transported to rural areas where these climatic conditions are harsher.

Insights into folic acid mixtures compounded with commercially available vitamin syrups

Stability assessments are crucial in determining the shelf-life and quality of compounded pharmaceutical products. Folic acid, an essential B-vitamin, is widely used to prevent and treat folate deficiency-related conditions. However, because of patient-specific demands or customised dose requirements, compounded folic acid syrups are frequently used in pediatric patients. This study aims to examine the stability of compounded folic acid mixtures prepared with some commercially available vitamin syrups. Three commercially available vitamin syrups were utilized as compounding vehicles for folic acid tablets, ensuring a representative sample of products commonly used in compounding practices in hospitals when conventional compounding vehicles are not available. The compounded folic acid mixtures were stored under ambient (21- 25 ºC) and refrigerated conditions (2-8 ºC), to simulate real-life scenarios, and tested using parameters such as, organoleptic characteristics, sedimentation rate, pH, microbial growth and drug content determination at day 7, 14 and 30. The extemporaneous preparations of the compounded folic acid in vitamin syrups generally maintained their physical characteristics over the 30-day study period. However, there was either decrease in folic acid concentration or microbial contamination of the preparations at day 7. Therefore, folic acid compounded in vitamin syrups are generally stable for less than seven days. The data obtained will aid healthcare professionals and compounding pharmacies in decision making concerning the choice of vehicle, compounding practices and strategies to ensure the preparation of wholesome extemporaneous products.

Quality assessment of metformin hydrochloride tablets retailed in Lagos, Nigeria

Background: Metformin is a biguanide antihyperglycemic drug used with diet and exercise for glycemic control in type 2 diabetes mellitus.Objectives: This research aims to compare and analyze different metformin products to ascertain their critical quality parameters. The goal is to ensure that prescribed medicine effectively treats patients and protects the public.Materials and Methods: We evaluated the quality of ten metformin tablet brands in Lagos (Mushin and Surulere area) using official methods to assess weight, hardness, friability, disintegration time, and dissolution. Active ingredient content was also measured.Results: Out of all the tablets tested, only 10 % had weights outside of the official British Pharmacopoeia 2002 limits (not more than two tablets should deviate from ±5% and none of the tablets should deviate by ± I0). The hardness test was passed by all the tablets (A minimum hardness of 4 kgF is a pass), while 80 % passed the friability test (weight loss of ≤ 1 %w/w is a pass). Additionally, all film-coated tablets disintegrated within 30 minutes according to United States Pharmacopoeia/National Formulary 2003 (film-coated tablets disintegrate within 30 minutes). Ninety percent of the tablets passed the dissolution test (drug release within 60 minutes should be between 93 and 103 %) and 90 % of all brands examined passed the assay test for the active ingredient contents. The British Pharmacopoeia 2019 standard was used for the dissolution test.Conclusion: Routine pharmaceutical analysis is essential for the quality of pharmaceutical products and the safety of consumers.

Pharmaceutical Promotions and Compliance with Community-Acquired Pneumonia Prescribing Guidelines by General Practitioners in Mbarara

Background: Generic prescribing effectively reduces dispensing errors and promotes the availability, access and quality of pharmaceutical products in health facilities or pharmacies. However, in Uganda, non-compliance with treatment guidelines is prevalent, with evidence of some General Practitioners (GPs) prescribing non-essential and obsolete drugs. This study examines the role of pharmaceutical promotions in creating awareness of new medicines among GPs and the potential influence of these promotions on prescribing practices.
 Methods: The study used a qualitative phenomenological research design. Key informant interviews were conducted with 33 experienced GPs from nine hospitals in Mbarara City, Uganda. The transcribed interviews were analysed using content analysis.
 Results: Most GPs were male (78.79%), aged between 41-50 years (30.30%), with a work experience of 6-10 years (39.39%). All GPs had at least been exposed to pharmaceutical promotions such as free samples, visits from medical representatives, and Continuing Medical Education sessions. Most GPs had a positive outlook on these promotions, which they believed were informative, educational, and beneficial. However, the more GPs depend on pharmaceutical promotions, the less likely they are to follow the national or international guidelines for generic prescribing.
 Conclusion: The study highlights the importance of ethical pharmaceutical promotion and the need for strict regulation by the National Drug Authority (NDA) to ensure that promotional activities do not compromise patient care and public health outcomes. The study recommends that GPs be more critical of the information and incentives provided during such promotions and should be trained in rational prescribing and evidence-based medicine.

Insight into Metabolomic Profiling of Tinospora cordifolia: Recent Advances and Future Perspectives of Quality Control

Abstract The objective of this study was to offer a review of previous works on Tinospora cordifolia (TC) metabolomics with a highlight on the use of metabolomics in comparative evaluations between varieties and selection of optimum cultivation, collection, and extraction procedures, providing insights into pharmaceutical and food product quality monitoring. Scholarly databases were searched to gather relevant information on TC’s therapeutic usefulness, phytoconstituent studies, metabolomics, and applications. PubChem was used to learn the structures of several of the metabolites. The various medicinal properties of TC were extensively researched. The most essential portions of the plant in Ayurvedic medicines are the stems. Bioactive phytochemicals such as steroidal lactones, alkaloids, diterpenoids, and phenolic compounds are present in the roots and leaves. Metabolomic analysis revealed that, in addition to the season and geographical region of the sample collected, the metabolite profiles of TC also depend on the parts of the plant taken as a sample and also the plant’s stage of growth. The amounts of secondary metabolites differed between morpho/chemotypes within the TC species. Despite the fact that research on TC began several decades ago, the diversity of phytoconstituents was not appreciated because of a lack of reliable techniques for phytochemical fingerprinting. The uncovering of several novel metabolites was aided by advances in chromatography combined with mass spectrometry. To produce a full metabolomic profile, researchers used mutually complementary techniques. Following that, data analysis and searches against spectrum databases allowed for signal annotation and interpretation of metabolites in large quantities without separating them separately. The current review includes a critical assessment of metabolomic data and an overview of the technique’s various applications. It is vital to establish the metrics of quality control of herbal medicines in order to accomplish formulation purity assessments. Such information would assist us in determining the best geolocation for the plants and the best time to harvest them. Metabolomic investigation of TC-based herbal products is recommended for quality standards and the identification of novel bioactive components.

აფთიაქების საქმიანობის უფლებამოსილების მინიჭების მექანიზმები

Pharmacy is a crucial healthcare service that ensures access to safe and effective medicines for the population. As such, the regulation of pharmacy and the licensing of pharmacies and pharmacists is essential to ensure the quality and safety of pharmaceutical products and services. The regulatory body is responsible for issuing licenses and permits, conducting inspections, and enforcing laws and regulations related to pharmacy practice. A pharmacy license can have different meanings depending on the context, but generally speaking, a pharmacy license is a legal authorization granted by a government or regulatory agency that allows a pharmacy to operate within a particular jurisdiction. In some cases, the license may be tied to the physical location of the pharmacy, which means that if the pharmacy changes ownership, the license can be transferred automatically to the new owner, as long as the new owner meets all the other requirements for operating a pharmacy. In other cases, the license may be tied to the responsible pharmacist who manages the pharmacy, which means that if the responsible pharmacist changes, the license may need to be revoked and a new one issued to the new responsible pharmacist. To summarize, a pharmacy is a healthcare facility that provides services related to the distribution of medicines. Licensing requirements for pharmacies vary by country, but typically involve both a license for the physical location of the pharmacy and a license for the responsible pharmacist operating the pharmacy. These licenses may be subject to specific conditions and mechanisms for issuance and revocation, depending on the country's legal framework and other factors. Ultimately, the goal of pharmacy licensing is to ensure that patients have access to safe and effective medications, regardless of their geographic location or economic status.

Quantitative analysis of rutin in flavonoid-rich plant raw material by HPTLC

Introduction. Due to the increasing requirements for the quality of pharmaceutical products, the requirements for standardization of herbal medicines are also growing, which in turn necessitates the development of approaches to quality control of medicinal plant raw materials. The use of such an advanced method as high-performance thin-layer chromatography (HPTLC) will improve the quality of drug standardization, which is associated with the advantages of this method: minimized sample preparation, parallel determination of small volumes, elution time, high sensitivity, efficiency and speed. Objective. Quantitative determination of rutin by high-performance thin-layer chromatography, as well as comparison of the results of quantitative determination of the amount of flavonoids in terms of rutin by the spectrophotometric method. Material and methods. Medicinal plant raw materials – violet herb – were subjected to extraction using a developed method with 70 and 96% ethanol. Quantitative determination of rutin in extracts was carried out by HPTLC and spectrophotometry. Results. The developed method for the quantitative determination of rutin was validated in terms of linearity, specificity and accuracy. The difference in the extractive ability of the solvents used was shown. The percentage of rutin determined using the HPTLC method in an ethanol (96%) extract (3 µl) is 3.0826%, in an ethanol (70%) extract (3 µl) – 1.5911%. The percentage of rutin determined using the HPTLC method in an ethanol (96%) extract (5 µl) is 3.0894%, in an ethanol (70%) extract (5 µl) – 1.6064%. The percentage of total flavonoids in terms of rutin determined using the spectrophotometric method in the ethanol (96%) extract is 3.4289%, in the ethanol (70%) extract – 2.4176%. Conclusion. As a result of the study, a method for the quantitative determination of rutin was developed and validated, which can be used in the standardization of violet herb.

Manufacturing DNA in E. coli yields higher-fidelity DNA than in vitro enzymatic synthesis

Biotechnologies such as gene therapy have brought DNA vectors to the forefront of pharmaceuticals. The quality of starting material plays a pivotal role in determining final product quality. Here we examined the fidelity of DNA replication using enzymatic methods (in vitro) compared to plasmid DNA produced in vivo in E. coli. Next-generation sequencing approaches rely on in vitro polymerases, which have inherent limitations in sensitivity. To address this challenge, we introduce a novel assay based on loss-of-function (LOF) mutations in the conditionally toxic sacB gene. Our findings show that DNA production in E. coli results in significantly fewer LOF mutations (80- to 3000-fold less) compared to enzymatic DNA replication methods such as PCR and rolling circle amplification (RCA). These results suggest that using DNA produced by PCR or RCA may introduce a substantial number of mutation impurities, potentially affecting the quality and yield of final pharmaceutical products. Our study underscores that DNA synthesized in vitro has a significantly higher mutation rate than DNA produced traditionally in E. coli. Therefore, utilizing in vitro enzymatically-produced DNA in biotechnology and biomanufacturing may entail considerable fidelity-related risks, while using DNA starting material derived from E. coli substantially mitigates this risk.

Development of innovative standards for the registration of drugs in India based on International norms

This research endeavors to pioneer a paradigm shift in drug registration protocols within the Indian pharmaceutical sector, aligning them with internationally recognized norms. The study delves into the imperative need for harmonizing regulatory standards to ensure the safety, efficacy, and quality of pharmaceutical products entering the Indian market. By integrating key benchmarks from global authorities, this initiative aims to foster a robust and transparent registration process, ultimately bolstering consumer trust and industry competitiveness. The research methodology encompasses a comprehensive review of international regulatory frameworks, comparative analysis, stakeholder consultations, and case studies to propose a refined set of standards tailored to the Indian context. Additionally, this study addresses potential challenges and proposes strategies for effective implementation. Through this innovative approach, the research aspires to lay the foundation for a more dynamic and globally integrated pharmaceutical landscape in India, poised for sustained growth and excellence.

Exploring the Evolution of Analytical Method Validation: Current Perspectives

In this review, we delve into the critical process of analytical method development and validation within the realm of pharmaceutical drug development. The creation of sound analytical methods stands as a cornerstone from the early stages of drug discovery through to the eventual marketing approval. Our objective is to meticulously examine the methodology behind developing, optimizing, and validating analytical methods, particularly focusing on their application to drug products – from the formulation's developmental stage to the production of commercial batches. We begin by elucidating the significance of method development tailored to the specific components of finished drug products or in-process tests. Additionally, we delve into the intricacies of sample preparation techniques essential for accurate analysis. Central to our discussion are the practical approaches employed to ascertain critical parameters including selectivity, specificity, limit of detection, limit of quantitation, linearity, range accuracy, precision, recovery, solution stability, ruggedness, and robustness of liquid chromatographic methods. These parameters are indispensable for supporting routine, in-process, and stability analyses crucial for ensuring the safety, efficacy, and quality of pharmaceutical products. By dissecting the intricacies of method development and validation, this review aims to provide pharmaceutical researchers and practitioners with valuable insights and practical guidelines to navigate the complex landscape of analytical method validation in drug development.

Statistical Process Control and Capability Six-pack for Conductivity Measurement in Medicinal Chemical Industry

Statistical Process Control (SPC) is indispensable in the medicinal chemical industry for maintaining pharmaceutical product quality and consistency. Background: With complex chemical processes and stringent regulatory standards, robust quality control measures are essential. SPC enables monitoring and control of key process parameters, identification and correction of process variations, and ensuring final product compliance with specifications. This study evaluates the quality and capability of a process measuring medicinal raw material quality from an international chemical manufacturing company. Methods: Data collected from the conductivity measurement process were analyzed using Minitab software. The process specification was fixed at 30 µS·cm-1 as a maximum permissible limit, with 33 subgroups of size one. The computation of the capability six-pack and analysis generated six plots providing insights into process stability, recent behavior, and capability against specifications, distribution verification and capability indices. Minitab® version 17.1.0 software was used to perform a process capability six-pack analysis, including various charts and statistics to assess process stability and capability. Results: The results indicate that while the process is stable, it lacks capability, with variations exceeding acceptable limit. The process does not meet the maximum allowable specification value, with deviations from normal distribution and following logistic dispersion pattern. Conclusion: The study's novelty lies in its comprehensive yet concise presentation of key metrics essential for evaluating process capability and performance, providing insights for process improvement and quality control. Further investigation and improvement actions are needed to address sources of variation and enhance process capability and performance.

Pharmaceutical Exports of Iran in OIC Region and Entering International Markets

Background: There are various pharmaceutical companies in Iran with high potential. Due to the lack of business with international markets for exports, Iranian pharmaceutical products are mostly traded in domestic markets. Despite numerous studies on pharmaceutical exports in the literature, the performance of Iran in pharmaceutical exports to the Organization of Islamic Cooperation (OIC), remains yet to be evaluated. The novelty of the present work lies in filling this research gap and helping develop policies to expand pharmaceutical exports of Iran.
 Materials and Methods: Analysis of results on the current performance of Iranian pharmaceutical exports indicated groups of factors. The most significant factors were product quality and government policies according to questionnaire survey.
 Results: Analysis of results on the current performance of Iranian pharmaceutical exports indicated groups of factors. The most significant factors were product quality and government policies according to questionnaire survey.
 Conclusion: It was concluded that supervision regulations of pharmaceutical exports were not developed to motivate the expansion of exports. Supervision and control of Iranian pharmaceutical industries would enhance the quality of pharmaceutical products and strongly contribute to the expansion of pharmaceutical exports. It was also found that the quality improvement of pharmaceutical products was a key factor in increasing pharmaceutical exports to international markets.

A Review on Analytical Challenges in Complex Formulations

In the realm of pharmaceutical development and manufacturing, the intricate world of complex drug formulations has garnered significant attention. These multifaceted formulations, often comprising a blend of active pharmaceutical ingredients (APIs) and excipients, present a myriad of analytical challenges. To address these complexities and ensure the safety, efficacy and quality of pharmaceutical products, the industry relies on a combination of advanced analytical techniques, comprehensive knowledge and unwavering commitment to regulatory standards. In the pursuit of solutions to these analytical challenges, the industry is also exploring emerging technologies, including microfluidic devices and mass spectrometry imaging. These innovative tools offer the potential for more detailed and precise analysis of complex formulations. The analytical challenges associated with complex drug formulations demand a multidisciplinary approach, combining traditional and advanced techniques to address the unique characteristics and requirements of each product. Overcoming these challenges is crucial, as it ensures the safety, efficacy and quality of pharmaceutical products, particularly in an industry driven by innovation and the quest to provide cutting-edge therapeutic solutions.

A Comparative Analysis of OIML Documents and Russian Rules on the Use of Reference Materials

The article analyzes the compliance of Russian legal documents with the Recommendations of the International Organization of Legal Metrology regarding the use of reference materials in the fields covered by the state control and supervision. The problem of ensuring the quality of measurement results is relevant for each laboratory, performing measurements in any fields of activity. In addition to a reliable and proven measurement method, a decisive role in obtaining comparable results is played by reference materials. In order to ensure the traceability of measurements, a reference material must be certified. Certified reference materials are obligatory for the state metrological control and supervision of the quality and safety of food and pharmaceutical products, quality of measurements in clinical laboratories, environmental safety, etc. Considering the important role of reference materials in the process of ensuring the uniformity of measurements in analytical laboratories, this study can contribute to the promotion of ideas for improving the Russian legislative framework in the relevant area.

Practical Analysis of Tap Water Dissolved Solids Efficient Reduction

Water is an essential component in the manufacturing of oral solid dosage forms in the pharmaceutical industry. The objective of the present study is to develop a compact and easy-to-maintain one-platform solution for generating high-purity water with near to zero Total Dissolved Solids (TDS) and low conductivity for pharmaceutical applications. To achieve this objective, different purification methods were explored and integrated into a single platform. The purification process involved the use of Electro-Deionization (EDI) in combination with double-pass Reverse Osmosis (RO), an activated carbon filter, water softeners, and micron filtration. The resource water was carefully selected based on specific criteria to ensure the quality of the final purified water. The developed one-platform solution successfully produced purified water with near to zero TDS and a conductivity level below 1 micro siemens/cm2. The integrated approach involving EDI and double-pass RO, along with supplementary filtration and treatment steps, proved to be highly effective in achieving the desired purity levels. The study demonstrated that the suggested one-platform solution is a reliable and efficient method for the production of high-purity water in the pharmaceutical industry. This system offers an easily maintainable and compact solution, making it suitable for various other industries such as semiconductor manufacturing and electric power generation where purified water with zero TDS is required. By providing a robust water purification process, this solution contributes to enhancing the quality and safety of pharmaceutical products and other critical applications that rely on ultra-pure water.

Evaluation of Quality Parameters of Light Sensitive Drugs Marketed in Nepal.

Photosensitivity is the response of drug or drug product to the exposure of solar, UV and visible light in the solid, semisolid, or liquid state that leads to a physical or chemical change. Exposure to light is a concern with numerous medications due to the potential for photo degradation or other chemical reactions that affect drug stability. Out of all the registered brands in Department of Drug Administration, 9 brands of Rabeprazole tablets, 5 brands of Promethazine tablets and 5 brands of methylcobalamin tablets were selected and were subjected for testing and analysis for various quality parameters as per pharmacopoeia. The labels of the collected medicine were analyzed. The obtained data were entered and analyzed in Microsoft office excel 2019. Eleven products did not comply with the existing regulatory requirement on labeling system of medicine as per Regulation of Standard of drugs. There was no uniformity in mentioning the self-life. Similarly, large variation was seen on price of same generic drugs. Information regarding storage conditions, direction for use and category of the drug were lacking in the label of some brands of medicines.Upon Laboratory analysis, two brands of promethazine tablets and three brands of Rabeprazole tablets were found substandard. Drug content of all the brands of Methylcobalamin was found to contain overage. The result of this study indicates that substandard medicines are abundant in Nepalese market. There is weak regulation monitoring which have resulted in no uniformity in similar pharmaceutical products too. Hence, stringent regulatory monitoring is required to assessthe quality of pharmaceutical products in the Nepalese market.

КАЧЕСТВО ФАРМАЦЕВТИЧЕСКОЙ ПРОДУКЦИИ С ТОЧКИ ЗРЕНИЯ ПОТРЕБИТЕЛЕЙ

Obtaining up-to-date marketing data by subjects of the market economy, including from consumers of pharmaceutical products, contributes to the adoption of the necessary management decisions in the field of improving the quality of manufactured pharmaceutical products. The purpose of the work was to analyze the quality of pharmaceutical products from the point of view of consumers. As an information base, the works of domestic and foreign scientists in the field of marketing, management, legal and organizational documentation on pharmaceutical activities are taken. The main research method was a survey, which resulted in a survey of 240 residents of the Oryol, Belgorod, Kostroma and Moscow regions. It has been established that the majority of consumers of pharmaceutical products believe: over the past five years, the quality of domestic drugs has increased; imported medicines have fewer visible defects; the legislation of the Russian Federation in the field of quality assurance of medicinal products during production needs to be tightened; the least visible defects are drugs in the price range from 501 to 1000 rubles. It was revealed that the population equally acquires domestic and foreign pharmaceutical products; doctors do not make preferences when prescribing imported and Russian medicines, but more often recommend original medicines; from dosage forms for internal use, the population prefers tablets and capsules, from external ointments; consumer preferences include many factors, including prolonged forms of drugs, independence of drug use from food intake, the presence of separation marks on tablets, coated tablets, combi drugs, the presence of secondary packaging, user-friendly instructions for drugs; the quality of pharmaceutical products is most influenced by substances, qualified personnel, modern equipment.

Metabolism and Chemical Degradation of New Antidiabetic Drugs: A Review of Analytical Approaches for Analysis of Glutides and Gliflozins.

The drug metabolism and drug degradation pathways may overlap, resulting in the formation of similar constituents. Therefore, the metabolism data can be helpful for deriving safe levels of degradation impurities and improving the quality of respective pharmaceutical products. The present article contains considerations on possible links between metabolic and degradation pathways for new antidiabetic drugs such as glutides, gliflozins, and gliptins. Special attention was paid to their reported metabolites and identified degradation products. At the same time, many interesting analytical approaches to conducting metabolism as well as degradation experiments were mentioned, including chromatographic methods and radioactive labeling of the drugs. The review addresses the analytical approaches elaborated for examining the metabolism and degradation pathways of glutides, i.e., glucagon like peptide 1 (GLP-1) receptor agonists, and gliflozins, i.e., sodium glucose co-transporter 2 (SGLT2) inhibitors. The problems associated with the chromatographic analysis of the peptide compounds (glutides) and the polar drugs (gliflozins) were addressed. Furthermore, issues related to in vitro experiments and the use of stable isotopes were discussed.

Analysing Impurities and Degradation Products

In the realm of pharmaceutical analysis, the analysis of impurities and degradation products takes centre stage, and its significance cannot be overstated. These undesired substances can profoundly impact the quality, safety and efficacy of pharmaceutical products, necessitating rigorous analytical methods and processes at every stage of drug development and manufacturing. Forced degradation studies are instrumental in identifying and characterizing impurities that may arise within a product, a pivotal source of information for quality control and regulatory compliance. Stability testing is integral to the batch release process, ensuring each product batch meets established stability criteria before entering the market. Stability testing and degradation studies are indispensable constituents of pharmaceutical analysis. They substantially contribute to preserving the quality, safety, and efficacy of pharmaceutical products. Beyond their regulatory mandates, these studies serve as proactive instruments for comprehending and supervising product stability across their life cycles. The insights gleaned from these endeavours inform critical judgments during drug development and manufacturing, ultimately assuring the welfare of patients and compliance with stringent regulatory requisites.