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进口化学试剂最常见的七种质量分类等级及纯度区别

进口化学试剂最常见的七种质量等级及纯度区别


化学试剂在药品、医疗器械、生物制品、细胞和组织产品以及许多其他医疗保健相关解决方案的制造和测试中发挥着关键作用,使用化学品和试剂的实验室和研究人员相信他们的制造商已经正确识别了每种化学品的等级,并确保这些化学品符合其预期用途的所有监管和合规标准,监管供应链中的每个人都必须了解和了解不同等级的化学品及其用途,本文将对此进行解释。


在制定解决方案时,制造商必须首先根据预期用途确定所需的化学纯度。以下列表描述了七种最常见的化学品和试剂等级,从最高到最低等级/纯度:


ACS级,ACS grade 达到或超过美国化学学会 (ACS) 制定的纯度标准。该等级可用于食品、药物或医药用途,可用于 ACS 应用或要求严格质量规范和纯度≥95% 的一般程序。

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试剂级,Reagent grade 通常等于 ACS 等级 (≥95%),可用于食品、药物或医药用途,适用于许多实验室和分析应用。



USP级,USP grade 符合或超过美国药典 (USP) 的要求。该等级可用于食品、药物或医药用途。它也用于大多数实验室用途,但在开始之前应始终审查所遵循的 USP,以确保等级适合该方法。

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NF级,NF grade 满足或超过美国国家处方集 (NF) 的要求。 USP 和 NF (USP-NF) 联合出版了一本关于化学和生物原料药、剂型、复方制剂、赋形剂、医疗器械和膳食补充剂的公共药典标准。应审查此处的列表以确定哪些将被视为等效等级。



实验室级,Laboratory grade 是教学实验应用中最流行的等级,但其确切的杂质水平尚不清楚。虽然非常适合教学和培训,但它的纯度不足以提供食物、药物或任何种类的药用。



纯化级,Purified grade 也称为Pure级或实用级,不符合官方标准;它不够纯净,不能提供给任何种类的食物、药物或药用。



工业级,Technical grade 用于商业和工业用途;然而,像许多其他未列级别一样,它还不够纯净,不能用于食物、药物或任何种类的药用。




ACS级、试剂级和 USP-NF 等级通常是等效的和可互换的,但即便如此,在应用前应始终确认适当性。这可以通过审查适用的监管要求来完成。


实验室级、纯化级和技术级各有各的用途。例如,实验室级化学品,因其成本低、化学纯度好,被广泛用于教学应用,如中学和大学的教学实验室;但是,实验室级化学品不适合在制药或医疗器械制造商的质量控制实验室中使用。 ACS 级、USP 级或试剂级化学品应在这种情况下使用,因为它们含有较少的杂质,最终可能影响服用这些化学品制成的药物的患者。


七种不同级别且不等价的化学纯度等级,了解它们如何影响产品至关重要。使用比产品预期用途要求更低的纯度等级可能是一个代价高昂的错误;同样,在不需要时使用更高纯度的等级可能会导致不必要的成本。再加上增加的监管审查,全面了解您的流程所需的组件变得更加重要。



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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