European pharmacopoeia reference standards

European pharmacopoeia reference standards DEFAULT

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EDQM / Job opportunities| News| 22 July | Strasbourg, France

Vacancy Notice - Scientific Assistant – Quality Management

Do you have a diploma in pharmacy, chemistry, biochemistry, biology or Quality Management Systems (QMS) with professional experience in QMS? Do you have the capacity to use your quality skills in the EDQM’s scientific-focused entities? Are teamwork, client orientation and analytical thinking part of your key skill set? Are you ready to play a critical role in maintaining a “Quality Culture”

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EDQM / Job opportunities| News| 22 July | Strasbourg, France

We are hiring: Principal Scientific Assistant – Hazard classification

Do you have experience in chemical hazard classification and Safety Data Sheet (SDS) requirements? Are you detail-oriented and able to work under pressure and meet deadlines? Do you have the excellent written and oral communication skills required to gather and provide technical information to users? Would you like to contribute to the activities of an International Organisation working for human

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EDQM / Job opportunities| News| 22 July | Strasbourg, France

Join the EDQM as Head of the Communications Section!

Do you have professional media or communications experience, including drafting press releases, social media news and responding to journalist requests, gained in a medical/scientific setting? Alternatively, do you have a scientific background with professional media or communications experience?  Would you be able to lead a team in implementing the EDQM’s communications strategy promoting the

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Sours: https://www.edqm.eu/en/news/reference-standards

Get access to harmonised quality standards applicable in Europe from 1 January

Why you need the European Pharmacopoeia

The European Pharmacopoeia (Ph. Eur.) is a single reference work for the quality control of medicines. The official standards it contains provide a scientific basis for quality control during the entire life cycle of a product.

These standards are legally binding – as laid down in the Council of Europe Convention on the Elaboration of a European Pharmacopoeia and in EU and national pharmaceutical legislation. Ph. Eur. quality standards become mandatory on the same date in all States Parties to the convention.

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The 10th Edition at a glance

  • Legally binding in 39 European countries and applied in more than countries worldwide.
  • Provides new and revised texts.
  • Delivers crucial information for European markets earlier than any other Pharmacopoeia.
  • The 10th Edition (including Supplement ) contains monographs (including dosage forms),  general texts (including general monographs and methods of analysis) and about descriptions of reagents.

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Initial release and updates

The 10th Edition of the Ph. Eur. was released in July and will be updated with eight periodic supplements over the following three years ( to ). 

Publication schedule for the Ph. Eur. 10th Edition () available here.

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Available in print and electronic versions

  • Print version: the 10th Edition consists of three initial volumes () complemented by eight non-cumulative supplements ( to ). For the convenience of users, direct access to complementary information (Knowledge Database) is included for each monograph and general chapter through a data matrix code. Available in either English or French, the print version contains a subscription key (EPID code) that allows access to online archives.
  • Electronic version:
  • completely cumulative versions, bilingual (English and French), with new features and direct access to complementary information (Knowledge Database);
  • access to the European Pharmacopoeia Online website from all recent common operating systems (tablet and smartphone friendly);
  • an application fully compatible with recent Windows and Linux operating systems;
  • Two installation options for each electronic licence: either individual or shared access (one option to be chosen):
    • individual use: install the application on one computer and on one USB stick, for online or offline use and easy access while on the move or in environments where using the book or the website is not possible or practical;
    • shared use: install the application on one computer or one USB stick, for online or offline use, for example for non-nominative access in university libraries or laboratories.

Technical requirements

Other features of the electronic version of the Ph. Eur. include:

  • direct links to texts;
  • search query management;
  • visibility of changes (for revised and corrected texts).

For more information and for technical specifications, please consult the EDQM FAQs and the user manual.

Access to archives included in the subscription. The Ph. Eur. online archives are available to all users with an up-to-date subscription (print or electronic).

 subscription

  • 10th Edition print version: the subscription includes the three non-cumulative updates (, and ) and provides access to the Ph. Eur. online archives until 31 December

  • 10th Edition electronic version: the subscription provides access to the cumulative content of the updates ( to ) as well as to the Ph. Eur. online archives until 31 December

  • Languages: the print version is available in either English or French, whereas the electronic version is bilingual (English and French).

  • Prices and offers:

    • € per subscription (print or electronic);
    • a package including both print and electronic versions is available at a significantly reduced price;
    • no handling charges (for the print version) when you order online;
    • save money by purchasing more than two electronic versions at the same time;
    • special prices for universities.
  • 10th Edition price list available here.

  • For more information, see “Sales information” opposite, or contact [email protected]

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Reseller

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Sours: https://www.edqm.eu/en/european-pharmacopoeia-ph-eurth-edition
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Catalogue

The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It is updated daily.

Download the PDF format of our catalogue here. To access the most updated information about our reference standards we advise to use the online database.

Online database

This database is updated daily and gives access to all our reference standards as well as to:

  • a list of newly adopted standards and batches and their released dates (click on "New" to consult this list);
  • Batch Validity Statement (BVS)* for each reference standard;
  • Safety Data Sheets;*
  • Leaflets.*

* These documents can be downloaded.

Search European Pharmacopoeia Reference standards

Important information

In order to ensure that reference to the EDQM Reference Standards is correctly reported, the EDQM would like to remind users that they have an obligation to ensure that any reference made to an EDQM Reference Standard in any publication, presentation or public document (ex. scientific articles, data sheets for kits) bears the exact name, and catalogue code of the Reference Standard and the exact name and address of EDQM as given by the EDQM on the label or in the official leaflet.

Sours: https://www.edqm.eu/en/ph-eur-reference-standards-orders-catalogue

Purpose and Use

The EDQM supplies chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP) as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the European Pharmacopoeia.

Establishment

Specific batches of candidate material are selected. These are characterised at the EDQM laboratory according to the principles described in Chapter (Reference Standards) of the European Pharmacopoeia and ‘ISO  General requirements for the competence of reference material producers'.

Candidate materials can also be the subject of international collaborative studies. Once adopted by the European Pharmacopoeia Commission, official reference standards become available for distribution. They are then used in pharmaceutical analysis, for example, for identification, purity tests or assays according to the corresponding monograph of general chapter of the European Pharmacopoeia.

For reference standards established within the Biological Standardisation Programme (BSP), go to BSPBackground & Mission.

Participate in Establishing the Reference Standards

The EDQM encourages OMCLs and other medicine control laboratories and donors of candidate materials to get involved in the establishment of its reference standards.

Sours: https://www.edqm.eu/en/ph-eur-reference-standards-purpose-and-use

Pharmacopoeia standards european reference

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What is a Pharmacopeia?

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