Impurities and stability studies.pdf
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impurities and stability studies in advanced pharmaceutical analysis. Definition of impurity, classification of impurity.
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INTRODUCTION
SCOPE OF GUIDELINES
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https://www.chapters.indigo.ca/en-ca/books/contributor/author/kiran-nivedh/
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Potential impurities in drug substance & drug product
Potential impurities are the substance which are formed during the reaction or already present in the form of starting materials, by products or intermediate products. Potential Impurities have no therapeutic value and are potentially harmful. Therefore, they need to be controlled.
Potential impurities may be arising due to:
• Residue of the starting material
• Residue of the intermediate
• Impurities in the starting material
• Reagents
• Solvents
• Catalysts
• Reaction by-products
• Degradation products
• Excipient-API interactions
• Drug substance/product manufacturing process
• Container closer interactions
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This quiz was conducted as a promotional event for the 2024 Annual Meet of Kerala Chapter of API.
More than 20 participants took part everyday !
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One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Cell Therapy Expansion and Challenges in Autoimmune Disease
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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- 1. IMPURITY AND STABILITY STUDIES Submitted by, Jikhila Machado 1st year M. Pharm Department of pharmaceutical analysis
- 2. IMPURITY Defined as any substance co-existing with the original drug, such as starting material or intermediates or that is formed due to any side reactions . → Impurity means presence of unwanted foreign particle other than active drugs which may be or may not be toxic and is found in pharmaceutical substance.
- 3. CLASSIFICATION Categories :- i) Organic Impurity (Process and drug related ) ii) Inorganic Impuri iii) Residual solvents => Organic Impurities Can arise during the manufacturing process and/or storage of the new drug substances.
- 4. -They can be identified or unidentified, volatile or non-volatile. - can be divided into two types : a) Degradation related impurities (DRI) -In finished products •API degradation •API excipients interactions •API residue interactions •API container interactions
- 5. b) Process related Impurities (PRI) -During the process •Excipients interactions •Starting material • Biproducts •Intermediates •Reagents, ligands, catalyst.
- 6. =>Inorganic Impurities -This can result from manufacturing process → normally known and identified - It include, •Reagents , catalyst, ligands •Heavy metals or other residual metals –cadmium , Arsenic, Cu •Inorganic salts such as Copper sulphate • other materials such as charcoal, filter aids.
- 7. =>Residual Solvents - Solvents are organic or inorganic liquids used as vehicles for the preparation of solutions, or suspensions in the synthesis of a new drug substances. - Residual solvents in pharmaceuticals are defined as organic volatile chemicals that Or used in the manufacturing of drug substances. • Organic solvents: - CHCl3, CCl4, Ethanol, Methanol etc. • Aqueous solvents :- Distilled water, Demineralised water, Hard water, soft water .
- 8. REFERENCES • Guidance for Industry Q3A –Impurities in New drug substances by, U. S. Department of health and human services, FDA, CDER, CBER, ICH –Revision 2,page no:1-6
- 9. THANK YOU