Definitions of reference standardsA

Definitions of reference standards
Apart from the challenges of marker selection and method development for herbal preparations, appropriate characterisation of reference standards is absolutely essential (EMA, 2008; Sahoo et al., 2010). There are official, often country-specific stipulations, which define the requirements that must be met by a compound in order to qualify as a reference standard. Furthermore, the term"reference standard" is also used in the context of reference preparations and reference spectra within the European Pharmacopoeia's scope of application (EDQM, 2012).
European Pharmacopoeia Chemical Reference Substances (CRS) offered by the European Directorate
on the Quality of Medicines & HealthCare (EDQM), are primary reference standards by definition. A primary standard is defined as being: "A standard shown to have suitable properties for the intended use, the demonstration of suitability being made without comparison to an existing standard." Establishment and qualification take place within the framework of an elaborate process, which frequently includes testing in several laboratories, as well as the performance of inter-laboratory tests. Secondary standards are derived by comparison with primary
standards. The term "working standard" is used to describe secondary standards that serve as standards within the framework of routine analysis. They are derived from primary reference standards and are therefore equivalent to secondary reference standards.
United States Pharmacopoeia (USP) Standards have been established in accordance with an extensive protocol and released for use by the USP References Substance Expert Committee. The rulings of the USP are described in detail in Section of the General Chapters (United States Pharmacopeial Convention 2012). A relatively new development is that substances that were
previously labelled "Authentic Substances" (AS) by the USP, which are highly characterised but not required for use in a USP-NF monograph, are now distributed as "USP Reference Standards". Although this transition simplifies the official definition, it does not absolve the customer from his obligation to prove suitability. Attention must be also paid to the validity statement for a current lot because it may be used only for as long as it remains listed on the web site (www.usp.org). Similar batch validity statements for reference substances from the EP are available from the EDQM home page (www.edqm.org). The user assumes responsibility for ensuring the validity of a batch and receives a substance with a label providing information concerning the quality but no certificate of analysis. In contrast to these official reference standards, some wellestablished and acknowledged suppliers offer marker compounds with comprehensive certificates of analysis, which may be used in the same way.

Hasil (Bahasa Indonesia) 1:

Definitions of reference standardsApart from the challenges of marker selection and method development for herbal preparations, appropriate characterisation of reference standards is absolutely essential (EMA, 2008; Sahoo et al., 2010). There are official, often country-specific stipulations, which define the requirements that must be met by a compound in order to qualify as a reference standard. Furthermore, the term"reference standard" is also used in the context of reference preparations and reference spectra within the European Pharmacopoeia's scope of application (EDQM, 2012).European Pharmacopoeia Chemical Reference Substances (CRS) offered by the European Directorateon the Quality of Medicines & HealthCare (EDQM), are primary reference standards by definition. A primary standard is defined as being: "A standard shown to have suitable properties for the intended use, the demonstration of suitability being made without comparison to an existing standard." Establishment and qualification take place within the framework of an elaborate process, which frequently includes testing in several laboratories, as well as the performance of inter-laboratory tests. Secondary standards are derived by comparison with primarystandards. The term "working standard" is used to describe secondary standards that serve as standards within the framework of routine analysis. They are derived from primary reference standards and are therefore equivalent to secondary reference standards.United States Pharmacopoeia (USP) Standards have been established in accordance with an extensive protocol and released for use by the USP References Substance Expert Committee. The rulings of the USP are described in detail in Section <11> of the General Chapters (United States Pharmacopeial Convention 2012). A relatively new development is that substances that were
previously labelled "Authentic Substances" (AS) by the USP, which are highly characterised but not required for use in a USP-NF monograph, are now distributed as "USP Reference Standards". Although this transition simplifies the official definition, it does not absolve the customer from his obligation to prove suitability. Attention must be also paid to the validity statement for a current lot because it may be used only for as long as it remains listed on the web site (www.usp.org). Similar batch validity statements for reference substances from the EP are available from the EDQM home page (www.edqm.org). The user assumes responsibility for ensuring the validity of a batch and receives a substance with a label providing information concerning the quality but no certificate of analysis. In contrast to these official reference standards, some wellestablished and acknowledged suppliers offer marker compounds with comprehensive certificates of analysis, which may be used in the same way.

Hasil (Bahasa Indonesia) 2:

Definisi standar referensi
Terlepas dari tantangan seleksi marker dan pengembangan metode untuk persiapan herbal, karakterisasi yang sesuai standar acuan adalah mutlak penting (EMA, 2008; Sahoo et al, 2010.). Ada, ketentuan sering khusus negara resmi, yang menentukan persyaratan yang harus dipenuhi oleh senyawa agar memenuhi syarat sebagai standar acuan. Selanjutnya, istilah "acuan standar" juga digunakan dalam konteks persiapan referensi dan spektrum referensi dalam lingkup Eropa Farmakope untuk aplikasi (EDQM, 2012).
Zat Pharmacopoeia Chemical Referensi Eropa (CRS) yang ditawarkan oleh Direktorat Eropa
Terhadap Kualitas obat & HealthCare (EDQM), adalah standar referensi utama dengan definisi. Sebuah standar primer didefinisikan sebagai: "Sebuah standar terbukti memiliki sifat yang cocok untuk penggunaan yang dimaksudkan, demonstrasi kesesuaian yang dibuat tanpa dibandingkan dengan standar yang ada." Pendirian dan kualifikasi berlangsung dalam kerangka proses yang rumit, yang sering mencakup pengujian di beberapa laboratorium, serta kinerja tes antar-laboratorium. Standar sekunder yang berasal dibandingkan dengan primer
standar. Istilah "standar bekerja" digunakan untuk menggambarkan standar sekunder yang berfungsi sebagai standar dalam kerangka analisis rutin. Mereka berasal dari standar acuan utama dan karena itu setara dengan standar referensi sekunder.
Farmakope Amerika (USP) Standar telah ditetapkan sesuai dengan protokol yang luas dan dirilis untuk digunakan oleh USP Referensi Komite Ahli Zat. Putusan dari USP dijelaskan secara rinci dalam Bagian <11> dari Bab Umum (Amerika Serikat Pharmacopeial Convention 2012). Sebuah perkembangan yang relatif baru adalah bahwa zat yang
sebelumnya diberi label "Authentic Zat" (AS) oleh USP, yang sangat ditandai tetapi tidak diperlukan untuk digunakan dalam monografi USP-NF, kini didistribusikan sebagai "Standar Referensi USP". Meskipun transisi ini menyederhanakan definisi resmi, itu tidak membebaskan pelanggan dari kewajiban untuk membuktikan kesesuaian. Perhatian harus juga membayar untuk pernyataan validitas untuk banyak saat ini karena hanya dapat digunakan selama tetap tercantum pada situs web (www.usp.org). Pernyataan serupa validitas batch zat referensi dari EP yang tersedia dari halaman rumah EDQM (www.edqm.org). Pengguna bertanggung jawab untuk memastikan keabsahan batch dan menerima zat dengan informasi label menyediakan mengenai kualitas tapi tidak ada sertifikat analisis. Berbeda dengan standar referensi resmi, beberapa pemasok wellestablished dan diakui menawarkan senyawa penanda dengan sertifikat komprehensif analisis, yang dapat digunakan dengan cara yang sama.