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Pharmaceutical Source of Impurities - An overview

Unwanted chemical entity present in a confined amount in API or FP. Differs in the chemical composition of that API or FP. Causes undesirable effect on the pharmaceutical product. Present naturally or arises during the manufacturing process<br><br>

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Pharmaceutical Source of Impurities - An overview

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  1. Pharmaceutical Impurities-An overview Corporate Presentation2017 Pharmaffiliates

  2. Meaning of Impurities – In the scientific parlance • Unwanted chemical entity present in a confined amount in API or FP • Differs in the chemical composition of that API or FP • Present naturally or arises during the manufacturing process • Causes undesirable effect on the pharmaceutical product Corporate Presentation2017 Pharmaffiliates

  3. Sources of impurities – An overview • Unwanted chemicals in API • Unreacted reactants, intermediates, reagents or residual solvents • A degradation product of API or formulation • By products arising during the synthesis of API or formulation Corporate Presentation2017 Pharmaffiliates

  4. Effects of impurities • Change the efficacy of the FP • Harmful effect on human health • Teratogenic, mutagenic and carcinogenic effects • No therapeutic role and are potentially harmful • Need to be controlled Corporate Presentation2017 Pharmaffiliates

  5. Classification of Impurities Synthesis related impurities Formulation related impurities Ageing related impurities Corporate Presentation2017 Pharmaffiliates

  6. Synthesis related Impurities • Organic Impurities • Starting material • Intermediates • By-products • Degradation products • Inorganic Impurities • Derive from manufacturing process • Excipients • Leached from the packing material • Residual Solvents • Use of Class I, Class II, Class III and Class IV should be limited • Should be used as per ICH permissible concentration limit Corporate Presentation2017 Pharmaffiliates

  7. Formulation Related Impurities • Dosage form impurities • Precipitation of main ingredients • Topochemical and nucleation reaction in the presence of moisture and excipients • Method/process related impurities • Environment related impurities • Temperature • Light-UV light • Humidity Corporate Presentation2017 Pharmaffiliates

  8. Ageing related impurities • Chemical reactions occur on ageing • Hydrolysis • Oxidation • Photolysis • Decarboxylation • Mutual interaction among ingredients on ageing • Effects of packaging material on ageing Corporate Presentation2017 Pharmaffiliates

  9. Role of Regulatory Authorities ICH Q3 guidelines classifies Impurities as • Organic Impurities • Inorganic Impurities • Residual Solvents • Metallic Impurities Corporate Presentation2017 Pharmaffiliates

  10. Impurity Profiling – An imperative aspect in New Drug Development • Identification • Characterization (structure elucidation) • Isolation (Quantitative determination) Corporate Presentation2017 Pharmaffiliates

  11. Role of a CRO (Contract Research Organization) • Reduces the time taken to conduct a project • Reduces cost of the hiring company • No infrastructure, office space or man power required for the hiring company • Manufacturing as per world class standards Corporate Presentation2017 Pharmaffiliates

  12. Pharmaffiliates - A reliable and preferred CRO partner • Pharmaffiliates, a strategic outsourcing firm located in the North Indian state of Haryana • Facility is stretched over 40,000 sq feet of work area and expansion capacity to 52,000 sq ft • Core team of 10 PhD’s and a total strength of almost 150 employees • Independent Quality Assurance, Regulatory affairs and Supply Chain management departments Corporate Presentation2017 Pharmaffiliates

  13. Pharmaffiliates - A reliable and preferred CRO partner • Over 10,000 impurity standards readily available in stock • State of art Research and Development department, with a core team of scientists having an expertise in chemistry. • Subject matter experts, who are engaged in the synthesis of impurities and metabolites of APIs and FPs • Identification and synthesis of degradants and impurities, that are new and challenging • Leading manufacturers of impurity standards, Chemical Intermediates, Drug Metabolites, Drug analogs, Analytical Standards and reference standards worldwide • Provides Full Time Equivalent (FTE) based projects Corporate Presentation2017 Pharmaffiliates

  14. Pharmaffiliates- A reliable and preferred CRO partner • Majority of the impurities synthesized at are 98% pure • Available in pack sizes as small as 50mg and 25mg. • Customized pack size suiting your requirement. • Complete structure elucidation and data interpretation with Certificate of Analysis Corporate Presentation2017 Pharmaffiliates

  15. Pharmaffiliates- A reliable and preferred CRO partner • Audited and accepted by USFDA and ISO 17025 • One of the largest inventory holder of impurities. • Present worldwide in more than 45 countries • Complete customized solution for Pharmaceutical research under one roof Corporate Presentation2017 Pharmaffiliates

  16. Thank you

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