EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (Under Process) , 

 ISSN 2394-3211

Impact Factor: 4.897

 ICV - 79.57

Abstract

EXTRACTABLES AND LEACHABLES - PHARMACEUTICAL REVIEW

Rajendra Phadke*, Rupali Mali and Dr. Amit Gosar

ABSTRACT

Establishing a link between extractables and leachables must necessary to understand, interpret, assess, quantify, or control the interaction between a drug product and its container/closure system. Extractables and Leachables (E/L) studies help to identify, quantify and minimize harmful impurities which could leach from pharmaceutical container closure systems and packaging into pharmaceutical products. To incorporate quality by design concepts into the management of leachable, an emphasis is often put on understanding the extractable profile for the materials of construction for manufacturing disposables, container-closure, or delivery systems. Component manufacturing processes may also impact the extractable profile. Since the FDA released their Container Closure Systems for Packaging Human Drugs and Biologics guidance in 1999, evaluation of final packaging components for extractables and leachables has become the expectation within the industry. Additionally, the increase in the use of single-use systems in manufacturing has drawn scrutiny as another potential source of extractables and leachables. These single-use systems include bioprocess bags, filters, tubing, fittings, connectors, bioreactors, etc. Many of these single-use systems are constructed from polymeric materials, increasing the concern of the introduction of leachable compounds to product. This paper considers the applied to evaluate the impact of material composition and processing parameters on extractable profiles and utilized to manage product leachable early in the development process and throughout the product lifecycle hence need to control impurities in drug product.

Keywords: Extractables and Leachables, Container closer, Analytical method development, Isolation and Characterization.


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (Under Process)