Stability Testing of Pharmaceutical Products

2021 ◽  
pp. 317-328
Author(s):  
Yashpal Singh Chauhan ◽  
Ravi Nex ◽  
Ghanshyam Sevak ◽  
Mahendra Singh Rathore
Keyword(s):  
Pharmaceutical Products ◽  
Test Methods ◽  
Pharmaceutical Product ◽  
Stability Test ◽  
World Health ◽  
Stability Testing ◽  
Container Closure ◽  
The Stability ◽  
Main Components ◽  
Health Organization

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

scholarly journals A REVIEW ON STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS

2020 ◽  
pp. 3-9
Author(s):  
ZOTHANPUII F ◽  
RAJESH R ◽  
SELVAKUMAR K
Keyword(s):  
Pharmaceutical Products ◽  
Test Methods ◽  
Pharmaceutical Product ◽  
Stability Test ◽  
World Health ◽  
Stability Testing ◽  
Container Closure ◽  
The Stability ◽  
Main Components ◽  
Health Organization

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

scholarly journals Extracranial metastases in secondary glioblastoma multiforme: a case report

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jessica Rossi ◽  
Lucia Giaccherini ◽  
Francesco Cavallieri ◽  
Manuela Napoli ◽  
Claudio Moratti ◽  
...  
Keyword(s):  
Brain Lesion ◽  
Rare Event ◽  
Subsequent Development ◽  
World Health ◽  
Who Grade ◽  
Systemic Involvement ◽  
Grade Ii ◽  
The Stability ◽  
Health Organization ◽  
Extracranial Metastases

Abstract Background Glioblastoma (GBM) is known for its devastating intracranial infiltration and its unfavorable prognosis, while extracranial involvement is a very rare event, more commonly attributed to IDH wild-type (primary) GBM evolution. Case presentation We present a case of a young woman with a World Health Organization (WHO) grade II Astrocytoma evolved to WHO grade IV IDH mutant glioblastoma, with subsequent development of lymphatic and bone metastases, despite the favorable biomolecular pattern and the stability of the primary brain lesion. Conclusions Our case highlights that grade II Astrocytoma may evolve to a GBM and rarely lead to a secondary metastatic diffusion, which can progress quite rapidly; any symptoms referable to a possible systemic involvement should be carefully investigated.

scholarly journals Ekstraksi dan Uji Stabilitas Zat Warna Alami dari Bayam Merah (Alternanthera amoena Voss)

KOVALEN ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. 212-217
Author(s):  
Khairuddin ◽  
Joy Noldy Baciang ◽  
Indriani ◽  
Nov Irmawati Inda
Keyword(s):  
Sun Exposure ◽  
Natural Dye ◽  
Natural Dyes ◽  
Stability Test ◽  
Stability Testing ◽  
Effect Of Ph ◽  
Color Degradation ◽  
The Stability ◽  
Better Than

Research on the extraction and stability test of natural dye from red spinach (Alternanthera amoena Voss) has been carried out. This study aims to determine the effect of pH and length of sun exposure on the stability of the dye from red spinach. Extraction using the maceration method with ethanol solvent and measurement using a UV-Vis spectrophotometer. Stability testing is carried out at pH 2-5 and sun exposure for 1-4 hours using a dark and light container. The results obtained, at pH 2 and pH 3, anthocyanins were more stable, compared to pH 4 and 5 which had greater color degradation. In exposure to sunlight, dark containers with a degradation percentage of 31.70% were better than clear containers with a percentage of 48.78%. Keywords: Anthocyanin, red spinach, natural dyes stability.

scholarly journals Impact of Covid-19 on banking business

2021 ◽  
Vol 18 (2) ◽  
pp. 79-90
Author(s):  
Marijana Joksimović ◽  
Jozefina Beke-Trivunac
Keyword(s):  
Credit Risk ◽  
World Health Organization ◽  
Banking System ◽  
World Health ◽  
Global Level ◽  
The World ◽  
Banking Business ◽  
The Stability ◽  
Health Organization ◽  
Positive Effect

The Covid-19 virus pandemic, declared in 2020 by the World Health Organization, has a very large impact on banking business around the world. The most significant problem is the growth of credit risk and the huge growth of demand for liquid assets. The crisis has also increased the risks associated with the digitalization of banking business and brought new risks posed by the work of employees from home. The timely reaction of regulatory authorities, at the global level, and the willingness of the monetary and fiscal authorities of all countries to cooperate have shown a very positive effect on the stability of the banking system.

Investigation of the physicochemical and pharmacognostical properties of Anzaroot (The manna of Astragalus sarcocola Dymock.) according to the World Health Organization

2020 ◽  
Vol 42 (5) ◽  
pp. 564-571
Author(s):  
Hadi Esmaeeli ◽  
Ali Davoodi ◽  
Masoud Azadbakht ◽  
Mohammad Azadbakht
Keyword(s):  
Traditional Medicine ◽  
World Health Organization ◽  
Pharmaceutical Products ◽  
Water Soluble ◽  
World Health ◽  
Flavonoid Content ◽  
Therapeutic Properties ◽  
The Common ◽  
Health Organization ◽  
Scientific Name

Background: Anzaroot is a manna produced from Astragalus sarcocola Dymock (Family Leguminosae) that is widely distributed in Fars, Kerman, Baluchestan and Hormozgan in Iran. Since the study of the physicochemical properties and quality control (QC) of herbal materials results in the validation and standardization for clinical uses, in accordance with World Health Organization (WHO) guidelines, it is necessary to carry out for Anzaroot which has indication in traditional medicine. Methods: Anzaroot was identified and determinated scientific name by a systematic specialist after purchasing from Niak pharmaceutical co. in gorgan. Physicochemical and pharmacognostical properties of Anzaroot have been determinated According to the WHO guidlines. Results: Anzaroot is a very bitter, crisp and fragile manna and non-stick in dry state, which is seen as separate binary grains under the microscope. The moisture content, foreign matter, sucrose content, total ash and water-soluble ash were reported 5.25 ± 0.2, 2.8 ± 0.2, 12.09 ± 0.04, 9.8 ± 0.5 and 2.9±0.15, respectively. It has significant foaming index, 72% Solublity in water and less than 50% in 96% ethanol and not swelling index. The levels of lead, mercury and cadmium were 0.0006, 0.0002 and 0.0007 ppm and total flavonoid content was reported 18.61 μg/ml with respect to standard Quercetin at 415 nm. Conclusion: This study can be a novel idea for the discovery or development of pharmaceutical products based on Anzaroot of Iran and its diverse therapeutic properties, such as the common cold, contusion, and bone fracture in traditional medicine.

scholarly journals SARS: Political Pathology of the First Post-Westphalian Pathogen

2003 ◽  
Vol 31 (4) ◽  
pp. 485-505 ◽  
Author(s):  
David P. Fidler
Keyword(s):  
Infectious Disease ◽  
Infectious Diseases ◽  
The United States ◽  
First Century ◽  
World Health ◽  
Health Security ◽  
The World ◽  
Twenty First Century ◽  
The Stability ◽  
Health Organization

In March 2003, the world discovered, again, that I humanity's battle with infectious diseases continues. The twenty-first century began with infectious diseases, especially HIV/AIDS, being discussed as threats to human rights, economic development, and national security. Bioterrorism in the United States in October 2001 increased concerns about pathogenic microbes. The global outbreak of severe acute respiratory syndrome (SARS) in the spring of 2003 kept the global infectious disease challenge at the forefront of world news for weeks. At its May 2003 annual meeting, the World Health organization (WHO) asserted that SARS is “the first severe infectious disease to emerge in the twenty-first century” and “poses a serious threat to global health security, the livelihood of populations, the functioning of health systems, and the stability and growth of economies.”

scholarly journals Review of Quality Deficiencies Found in Active Pharmaceutical Ingredient Master Files Submitted to the WHO Prequalification of Medicines Programme

2014 ◽  
Vol 17 (2) ◽  
pp. 169 ◽  
Author(s):  
Isabel Ortega Diego ◽  
Antony Fake ◽  
Matthias Stahl ◽  
Lembit Rägo
Keyword(s):  
Technical Assistance ◽  
Active Pharmaceutical Ingredient ◽  
The United States ◽  
World Health ◽  
European Medicines Agency ◽  
United States Food ◽  
Materials Used ◽  
The Stability ◽  
Health Organization ◽  
Over Time

Purpose. The aim of this work was to determine the number and type of active pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as submitted to the World Health Organization (WHO) Prequalification of Medicines Programme (PQP). Methods. We conducted a retrospective review of API quality deficiencies identified following the assessment of new APIMFs for non-sterile APIs during a 6-year period from 1 January 2007 to 31 December 2012. All deficiencies were collected, classified and quantified according to the Common Technical Document (CTD) sections and subsections and as groups of commonly raised questions. Results. There were 5446 deficiencies collected from 159 APIMF deficiency letters by CTD section, by selected CTD subsections and by selected CTD subsections and year. More than 50% of the total number of deficiencies related to the manufacturing sections of the CTD, followed by deficiencies concerning the impurities, the API specification and the stability sections of the CTD.  A pattern of API deficiencies across the different CTD subsections and over time was identified. Conclusions. The most frequent critical deficiencies were related to how the specific manufacturing process and the key materials used, in particular the API starting material, impact the API impurities content. The number and pattern of APIMF deficiencies did not change over time. The results are compared to the findings in similar studies as reported by the United States Food and Drug Administration (USFDA), the European Directorate for the Quality of Medicines (EDQM) and the European Medicines Agency (EMA) and similarities and differences are discussed. Our findings highlight the need for greater guidance and technical assistance for API manufacturers submitting APIMFs to the PQP. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Development of wheelchair caster testing equipment and preliminary testing of caster models

2017 ◽  
Vol 6 ◽  
Author(s):  
Anand Mhatre ◽  
Joseph Ott ◽  
Jonathan Pearlman
Keyword(s):  
Environmental Conditions ◽  
Failure Modes ◽  
Test System ◽  
Test Methods ◽  
World Health ◽  
Expert Opinions ◽  
Adverse Environmental Conditions ◽  
Health Organization ◽  
Testing Standards ◽  
Future Work

Background: Because of the adverse environmental conditions present in less-resourced environments (LREs), the World Health Organization (WHO) has recommended that specialised wheelchair test methods may need to be developed to support product quality standards in these environments. A group of experts identified caster test methods as a high priority because of their common failure in LREs, and the insufficiency of existing test methods described in the International Organization for Standardization (ISO) Wheelchair Testing Standards (ISO 7176).Objectives: To develop and demonstrate the feasibility of a caster system test method.Method: Background literature and expert opinions were collected to identify existing caster test methods, caster failures common in LREs and environmental conditions present in LREs. Several conceptual designs for the caster testing method were developed, and through an iterative process using expert feedback, a final concept and a design were developed and a prototype was fabricated. Feasibility tests were conducted by testing a series of caster systems from wheelchairs used in LREs, and failure modes were recorded and compared to anecdotal reports about field failures.Results: The new caster testing system was developed and it provides the flexibility to expose caster systems to typical conditions in LREs. Caster failures such as stem bolt fractures, fork fractures, bearing failures and tire cracking occurred during testing trials and are consistent with field failures.Conclusion: The new caster test system has the capability to incorporate necessary test factors that degrade caster quality in LREs. Future work includes developing and validating a testing protocol that results in failure modes common during wheelchair use in LRE.

scholarly journals Effect of Repeated Freeze–Thaw Cycles on Influenza Virus Antibodies

Vaccines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 267
Author(s):  
Alessandro Torelli ◽  
Elena Gianchecchi ◽  
Martina Monti ◽  
Pietro Piu ◽  
Irene Barneschi ◽  
...  
Keyword(s):  
World Health ◽  
Who Guidelines ◽  
Serum Samples ◽  
Serological Tests ◽  
Freeze Thaw ◽  
Before And After ◽  
The Stability ◽  
Health Organization ◽  
Internal Procedures ◽  
The Impact

Background: Vaccine effectiveness relies on various serological tests, whose aim is the measurement of antibody titer in serum samples collected during clinical trials before and after vaccination. Among the serological assays required by the regulatory authorities to grant influenza vaccine release there are: Hemagglutination inhibition (HAI), microneutralization (MN), and Single Radial Hemolysis (SRH). Although antibodies are regarded to be relatively stable, limited evidences on the effect of multiple freeze–thaw cycles on the stability of antibodies in frozen serum samples are available so far. In view of this, the present paper aimed to evaluate the impact of multiple freeze–thaw cycles on influenza antibody stability, performing HAI, MN and SRH assays. Methods: Ten serum samples were divided into 14 aliquots each, stored at −20 °C and taken through a total of 14 freeze–thaw cycles to assess influenza antibody stability. Each assay measurement was carried out following internal procedures based on World Health Organization (WHO) guidelines. Results: No statistically significant effect of 14 freeze–thaw cycles on antibody stability, measured through three different assays, was observed. Conclusions: Collectively, these data demonstrated that specific influenza antibody present in serum samples are stable up to 14 freeze–thaw cycles.

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