High performance liquid chromatography, or HPLC, is an analytical testing instrument used to separate components out of a sample in an effort to identify and quantify the ingredients within a formulation. It has many uses in the medical, polymer, coatings, pharmaceutical, and other commercial or industrial industries. For those regulated by the FDA or governed by industrial standards, HPLC analysis is an industry tool for product validation and can be used for both qualitative and quantitative analysis.
A HPLC analysis can be used to test both the raw materials and the finished goods. When first finding a raw material supplier or for routine quality control checks it is important to test the raw materials to ensure you have received the correct purity and grade of product. Many raw materials look and feel alike, but to truly understand if you are receiving exactly what you are paying for they should be tested and verified.
Manufacturers also use laboratories with hplc capabilities to also reverse engineer formulations, solve product failure problems, perform competitor product analyses, and look for contaminants or other impurities. These types of testing can be performed on both the raw materials and the finished product.
Often times once the manufacturing process is finished, the final product is tested again to verify it contains the proper amount of active ingredients as claimed on the label. And since this type of testing will identify any contaminates or other product defect that may have occurred with the batch during the manufacturing process, performing these tests will reduce the chance of having product recalled.
HPLC analysis can also be used in conjunction with additional analytical instrumentation to determine the stability and shelf life of products. The advantages of using HPLC for analysis are that it requires a small sample size, testing can be modified depending on level of quantification needed, and it produces reliable results. Using an hplc laboratory can help you develop better products, gain a better understanding of your competitors products, and can be used to help solve/prevent product recalls.
Labels: HPLC Analysis