edqm каталог стандартных образцов

Ph. Eur. Reference Standards: Orders & Catalogue

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:

* These documents can be downloaded.

pheur ref standards database

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.

How to order or request a quotation

Orders or quotation requests can be submitted to the EDQM:

Please submit each order or request only once, either via the WebStore or by e-mail.

Before ordering, we advise you to check the availability of the reference standards in our online database and to read our Terms and Conditions.

For more detailed instructions, please read «Order and dispatch of EDQM products».

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WHO ICRS Orders & Catalogue

EDQM / WHO ICRS collaboration

The EDQM and the World Health Organization (WHO) are pleased to announce that EDQM is responsible for the distribution of WHO’s International Chemical Reference Substances (ICRS).

The EDQM takes over responsibility for the establishment, preparation, storage and distribution of WHO ICRS from Apoteket AB, previously the WHO Collaborating Centre for ICRS. Reference material that was held and distributed by Apoteket AB will now be distributed by the EDQM.

ICRS are adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quality control of drugs published in the International Pharmacopoeia.

The EDQM will also organise international collaborative studies to establish new standards when required with WHO’s assistance.

Online database

Please consult the International Chemical Reference Substances database to:

icrs reference database

How to order or request a quotation

Orders or quotation requests can be submitted to the EDQM:

Please submit each order or request only once, either via the WebStore or by e-mail.

Before ordering, we advise you to check the availability of the reference standards in our online database and to read our Terms and Conditions.

For more detailed instructions, please read «Order and dispatch of EDQM products».

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Ph. Eur. Reference Standards: Purpose and use

Purpose and Use

Establishment

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 BSP Background & Mission.

Participate in Establishing the Reference Standards

Affiliation & conflict of interest statement

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is an independent organisation, free from any undue influence and confirms that it does not have privileged ties with any pharmaceutical company or provider of reference standards.

Having been recently informed that certain commercial providers of reference standards claim their key staff are former senior employees of the EDQM, we questioned the companies concerned and received no reply.

We therefore confirm that, to the best of our knowledge, these claims are unfounded.

PURPOSES AND USES OF EUROPEAN PHARMACOPOEIA REFERENCE STANDARDS

purposes and uses of european pharmacopoeia reference standards 2021 page 1

Videos

Reference Standards
This short video presents how the Reference Standards (RS) are manufactured at EDQM and distributed worldwide from EDQM.

The EDQM secondary building
Video and Media kit

about us presskit edqm inauguration secondary site page 01

Useful information

Looking for a Reference Standard?

Search for availability, price, batch validity statements (BVS), leaflets, safety data sheets (SDS), a list of newly adopted reference standards, batch release dates.

pheur ref standards database

Place an order

icrs order online

Council of europe portal

EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71

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Databases

Pharmeuropa

Knowledge

Melclass

The Melclass database contains the legal classification of medicines regarding their supply: conditions and details of prescription status.

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Каталоги поиска стандартных образцов

В этой статье мы рассмотрим вопрос поиска стандартных образцов и приведем ссылки на официальные каталоги наиболее востребованных поставщиков СО.

Каталоги стандартных образцов:

В РФ в нормативной документации на ЛС обычно предусматривают использование стандартных образцов Европейской, Британской и Американской фармакопей, что связано с отсутствием собственной системы производства, стандартизации и распространения фармакопейных СО.

При поиске и выборе стандартных образцов необходимо помнить, что их квалификация должна соответствовать целевому назначению. Так, многие СО EP CRS не подходят (не аттестованы) для количественного определения действующих веществ.

В целях экономии в нормативной документации разумно предусмотреть использование альтернативных (дополнительных) СО. При регистрации обычно без проблем проходят ФСО ГФУ.

В качестве примесей возможно использовать реактивы от Sigma-Aldrich, Merck и других производителей. Чистота и количественное содержание в этом случае не так важны. Главное, чтобы в сертификате была доказана структура вещества.

Стандартные образцы от LGC, Molcan и Toronto Research Chemicals обычно также очень дороги и используются в основном в случаях отсутствия соответствующих фармакопейных СО.

Примечание: Следует также иметь ввиду, что с юридической точки зрения СО EP CRS, BP CRS и USP RS могут использоваться только для целей и в условиях, предусмотренных монографией соответствующей фармакопеи. Это положение в полной мере касается аналитических методик. Обычно все сертификаты анализа на фармакопейные СО сопровождаются отказом от ответственности (Disclaimer) при non-compendial использовании. Однако, в настоящее время, регуляторные органы РФ не обращают на это абсолютно никакого внимания.

Более подробно о выборе и деталях использования стандартных образцов будет рассказано в нашей следующей статье.

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    Pharmeuropa Bio & Scientific Notes

    Pharmeuropa provides public inquiries on draft European texts or on matters of general policy, the latest official announcements on freshly adopted monographs, the latest news on Pharmacopoeial harmonisation and a readers’ tribune.

    Pharmeuropa Bio & Scientific Notes contains all the news in the biological standardisation area and scientific articles linked to the work of the European Pharmacopoeia.

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    Ph. Eur. Reference Standards

    Knowledge is a searchable database of information on a given substance or general method of analysis. It also contains information such as the revision history of monographs; chromatograms in PDF format; links to the reference standard catalogue number; trade names of some reagents, such as chromatography columns and biological kits; and access to the list of Certificates of Suitability (CEPs) of the European Pharmacopoeia monographs that have been granted for each substance.

    Search through our continually updated database for information on Ph. Eur. Reference Standards.

    WHO ISA

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    WHO ICRS

    This database contains information on WHO International Standards for Antibiotics (ISA).

    This database contains information on WHO International Chemical Reference Substances (ICRS).

    Certification

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    Standard Terms

    Search our Certification database for information on Certificates of Suitability (CEPs) granted by the EDQM.

    The Standard Terms database contains terms and definitions to describe pharmaceutical dose forms, routes and methods of administration, containers, closures and administration devices and patient-friendly terms.

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