USP 43 NF38 is a US Pharmacopeia chapter that lays out requirements for the uniform quality control of pharmaceutical and medical devices. This chapter is intended to provide standards for testing and validating the purity, potency, and effectiveness of the products that may be in contact with humans.
The USP 43 NF38 highlights the various parameters that pharmaceutical and medical products must adhere to in regards to the following:
-Purity: The amount of impurity or active ingredient in the product must meets certain quality standards, must also not be adulterated with any adulterants, and must not contain any prohibited substances.
-Potency: The amount of active ingredient present in the product must be sufficient in order for the product to be effective.
-Effectiveness: The product must be capable of performing its intended purpose.
-Stability: The product must remain stable and consistent in quality over time.
These guidelines are intended to ensure the safety and efficacy of any and all medical and pharmaceutical products. USP 43 NF38 is available in its entirety and free of cost, at the website of the US Pharmacopeia.
For more information, please see the following links:
USP 43 NF38: https://www.usp.org/usp-nf/notices/usp-43-nf-38-general-chapter
US Pharmacopeia: https://www.usp.org/