Quality and purity
USP-grade substances are expected to meet high standards of quality and purity. This includes specifications for the composition, strength, and identity of the substance.
Pharmaceuticals and dietary supplements
The USP standards are particularly significant in the pharmaceutical and dietary supplement industries. Pharmaceutical companies use USP standards to ensure the quality of drugs, and dietary supplement manufacturers may adhere to USP standards to demonstrate the quality of their products.
Testing and verification
To achieve USP-grade status, a substance undergoes rigorous testing and verification processes as outlined in the USP standards. These tests may include analytical testing, assays, and other methods to ensure that the substance meets the required specifications.
While the USP is a U.S.-based organisation, its standards are recognized and used globally. Many countries and international organisations refer to USP standards as a benchmark for quality in pharmaceuticals and related products.
USP publishes monographs that provide detailed specifications for individual substances, including tests and acceptance criteria. Manufacturers can refer to these monographs to ensure their products meet the defined standards.
USP-grade substances are expected to be traceable back to a specific source or manufacturer. This traceability enhances accountability and helps ensure consistency in the quality of products.
Compliance with GMP
Manufacturers producing USP-grade substances are often required to follow Good Manufacturing Practices (GMP) to ensure the quality and consistency of their processes.
Labelling and certification
Products that meet USP standards may display the USP verification mark on their packaging, indicating that the product has been independently tested and verified to meet the established standards.
It's important to note that the USP-grade designation is specific to the standards set by the United States Pharmacopeia. Other regions may have their own pharmacopoeias with similar standards, such as the European Pharmacopoeia (Ph.Eur.) or the Japanese Pharmacopoeia (JP). Manufacturers and consumers use these standards to ensure the quality and safety of pharmaceuticals and related products.
Nedstar offers USP-grade products for use, for example, in manufacturing pharmaceuticals or as active ingredients in personal care products. The USP (US Pharmacopeia) sets the potency and purity standards for pharmaceutical-grade chemicals and solvents. A USP-grade product meets or exceeds these standards, and so can be used in food, drugs or medicinal products and for most lab purposes.