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  • 首頁 >> 實驗指南 >>分析化學 >> 進口化學試劑最常見的七種質量分類等級及純度區別
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    進口化學試劑最常見的七種質量分類等級及純度區別

    進口化學試劑最常見的七種質量等級及純度區別


    化學試劑在藥品、醫療器械、生物制品、細胞和組織產品以及許多其他醫療保健相關解決方案的制造和測試中發揮著關鍵作用,使用化學品和試劑的實驗室和研究人員相信他們的制造商已經正確識別了每種化學品的等級,并確保這些化學品符合其預期用途的所有監管和合規標準,監管供應鏈中的每個人都必須了解和了解不同等級的化學品及其用途,本文將對此進行解釋。


    在制定解決方案時,制造商必須首先根據預期用途確定所需的化學純度。以下列表描述了七種最常見的化學品和試劑等級,從最高到最低等級/純度:


    ACS級,ACS grade 達到或超過美國化學學會 (ACS) 制定的純度標準。該等級可用于食品、藥物或醫藥用途,可用于 ACS 應用或要求嚴格質量規范和純度≥95% 的一般程序。

    image.png


    試劑級,Reagent grade 通常等于 ACS 等級 (≥95%),可用于食品、藥物或醫藥用途,適用于許多實驗室和分析應用。



    USP級,USP grade 符合或超過美國藥典 (USP) 的要求。該等級可用于食品、藥物或醫藥用途。它也用于大多數實驗室用途,但在開始之前應始終審查所遵循的 USP,以確保等級適合該方法。

    image.png


    NF級,NF grade 滿足或超過美國國家處方集 (NF) 的要求。 USP 和 NF (USP-NF) 聯合出版了一本關于化學和生物原料藥、劑型、復方制劑、賦形劑、醫療器械和膳食補充劑的公共藥典標準。應審查此處的列表以確定哪些將被視為等效等級。



    實驗室級,Laboratory grade 是教學實驗應用中最流行的等級,但其確切的雜質水平尚不清楚。雖然非常適合教學和培訓,但它的純度不足以提供食物、藥物或任何種類的藥用。



    純化級,Purified grade 也稱為Pure級或實用級,不符合官方標準;它不夠純凈,不能提供給任何種類的食物、藥物或藥用。



    工業級,Technical grade 用于商業和工業用途;然而,像許多其他未列級別一樣,它還不夠純凈,不能用于食物、藥物或任何種類的藥用。




    ACS級、試劑級和 USP-NF 等級通常是等效的和可互換的,但即便如此,在應用前應始終確認適當性。這可以通過審查適用的監管要求來完成。


    實驗室級、純化級和技術級各有各的用途。例如,實驗室級化學品,因其成本低、化學純度好,被廣泛用于教學應用,如中學和大學的教學實驗室;但是,實驗室級化學品不適合在制藥或醫療器械制造商的質量控制實驗室中使用。 ACS 級、USP 級或試劑級化學品應在這種情況下使用,因為它們含有較少的雜質,最終可能影響服用這些化學品制成的藥物的患者。


    七種不同級別且不等價的化學純度等級,了解它們如何影響產品至關重要。使用比產品預期用途要求更低的純度等級可能是一個代價高昂的錯誤;同樣,在不需要時使用更高純度的等級可能會導致不必要的成本。再加上增加的監管審查,全面了解您的流程所需的組件變得更加重要。



    The Seven Most Common Grades for Chemicals and Reagents

    It is imperative that everyone in the custody supply chain know and understand the different grades of chemicals and their uses


    Chemicals and reagents play a critical role in the manufacturing and testing of pharmaceutical products, medical devices, biologics, cell- and tissue-based products, and many other healthcare-related solutions. Laboratories and researchers who use chemicals and reagents trust that their manufacturers have properly identified the grades of each chemical and ensured that the chemicals have met all regulatory and compliance standards for their intended use. It is imperative that everyone in the custody supply chain know and understand the different grades of chemicals and their uses, which are explained in this article.

    When making a solution, the manufacturer must first decide what degree of chemical purity is needed based on the intended use. The following list describes the seven most common grades for chemicals and reagents, from highest to lowest grade/purity:

    ACS grade meets or exceeds purity standards set by the American Chemical Society (ACS). This grade is acceptable for food, drug, or medicinal use and can be used for ACS applications or for general procedures that require stringent quality specifications and a purity of ≥95%.

    Reagent grade is generally equal to ACS grade (≥95%) and is acceptable for food, drug, or medicinal use and is suitable for use in many laboratory and analytical applications.

    USP grade meets or exceeds requirements of the United States Pharmacopeia (USP). This grade is acceptable for food, drug, or medicinal use. It is also used for most laboratory purposes, but the USP being followed should always be reviewed prior to beginning to ensure the grade is appropriate for that methodology.

    NF grade meets or exceeds requirements of the National Formulary (NF). The USP and the NF (USP– NF) jointly publish a book of public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. The listings here should be reviewed to determine which would be considered equivalent grades.

    Laboratory grade is the most popular grade for use in educational applications, but its exact levels of impurities are unknown. While excellent for teaching and training, it is not pure enough to be offered for food, drug, or medicinal use of any kind.

    Purified grade, also called pure or practical grade, meets no official standard; it is not pure enough to be offered for food, drug, or medicinal use of any kind.

    Technical grade is used for commercial and industrial purposes; however, like many others, it is not pure enough to be offered for food, drug, or medicinal use of any kind.


    ACS, Reagent, and USP-NF grades are typically equivalent and interchangeable but, even so, appropriateness should always be confirmed before application. This can be done by reviewing the applicable regulatory requirements.

    Lab, purified, and technical grades have their own uses. For example, lab-grade chemicals, because of their low cost and good chemical purity, are used widely in educational applications, such as teaching laboratories at both the secondary school and college levels; however, lab-grade chemicals would not be appropriate for use in the quality control laboratory of a pharmaceutical or medical device manufacturer. ACS-, USP-, or reagent-grade chemicals should be applied in this setting, because they have fewer impurities that could ultimately impact patients taking the drugs made with those chemicals.


    With seven different and inequivalent types of chemical purity grades, it is crucial to understand how they can impact products. Using a lower-purity grade than a product’s intended use requires could be a costly mistake. Similarly, using a higher-purity grade when not required could result in unnecessary costs. Add in the increased regulatory scrutiny and it becomes even more important to have a complete understanding of the components that your process requires.


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