In the pharmaceutical industry, accurate and reliable chemical analysis is essential. The United States Pharmacopeia (USP) has developed several standards to ensure the quality and safety of pharmaceutical products. These standards include USP 788, USP 789, USP 790 and USP 1790. In this article, we explain what these standards mean, what the differences are and how we can help you comply with them.
What is USP 788?
USP 788 is a standard that describes the requirements for the determination of particle number and particle size in injectables. These tests are crucial for quality assurance and safety assessment of pharmaceutical products. The procedure includes both light transmission methods and microscopy methods. The aim is to ensure that injectables are free from particle contamination that could affect the efficacy and safety of the product.
Differences between USP 788, USP 789, USP 790 and USP 1790
Each of these USP standards has specific test methods and requirements that are customized for different product types and applications:
- USP 789: This standard focuses on the determination of particles in ophthalmic (eye) solutions. As these products come into direct contact with the sensitive eye area, strict requirements for particle size and number are essential.
- USP 790: Refers to particle contamination in protein solutions. Since protein preparations often contain sensitive active ingredients, the control of particles in these solutions is particularly important.
- USP 1790: Covers specific requirements for subvisually visible particles. These particles are not visible to the naked eye, but can be detected under certain conditions.
Importance of compliance with USP standards
Compliance with USP standards is crucial to ensure the safety and efficacy of pharmaceutical products. It helps to meet regulatory requirements and increase confidence in product quality. Manufacturers who adhere to these standards can ensure that their products meet the highest quality requirements and are therefore safe and effective for patients.
Compliance with USP standards is essential for quality assurance in the pharmaceutical industry. With Giant Labs GmbH, you have a reliable partner at your side to support you in implementing these requirements. Contact us to learn more about our services and how we can help you analyze your products to the highest quality standards.
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