EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

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 (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , Scope Database , Academia , 

 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

STUDY OF STABILITY AND LABELING REQUIREMENTS OF INHALATION AND NASAL PRODUCT IN US AND EUROPE

Darshil B. Shah*, Deval K. Shah, Dr. Dilip G. Maheshwari

ABSTRACT

Inhalation and Nasal products are used in the Asthma and COPD so it requires precise regulation. Stability studies ensure the maintenance of product quality throughout the shelf life that is pre-requisite for the acceptance and approval of Inhalation and Nasal product. Stability studies play an important role in Inhalation development, possibly more than other delivery systems. These studies are required to conduct in a planned approach following the rules issued by ICH. Labeling is essential for any pharmaceutical product as it gives all the detail about the product which will be benefit for patient. Label facilitate manufacturer to market their product and catch people’s attention. It is useful to Consumer additionally to allow them distinguish the product form one another. In this article Stability studies which are required for Inhalation and Nasal product are same for both the countries. By studying the stability guideline we can easily find out the shelf life of the product and it is necessary for pharmaceutical companies to file their product in US and Europe. And labeling requirement which is essential for Inhalation and Nasal product are given in both the countries.

Keywords: Stability Requirements, labeling, Stability studies, ICH, Inhalation and Nasal product.


[Full Text Article] [Download Certificate]

Citation

  All Since 2019
 Citation  3086  2560
 h-index  18  17
 i10-index  64  44

INDEXING

NEWS & UPDATION

  • New Issue Published

    Its Our pleasure to inform you that, EJPMR 1 March 2024 Issue has been Published, Kindly check it on https://www.ejpmr.com/issue

  • EJPMR: MARCH ISSUE PUBLISHED

    MARCH 2024 issue has been successfully launched on MARCH 2024.

  • EJPMR New Impact Factor

    EJPMR Impact Factor has been Increased to 7.065 for Year 2024.

  • Index Copernicus Value

    EJPMR Received Index Copernicus Value 79.57, due to High Quality Publication in EJPMR at International Level

  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.

    .

  • Article Invited for Publication

    Article are invited for publication in EJPMR Coming Issue

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 (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia