Impurities Identification

What is Impurities? Where is It Coming From?

Impurities are chemical substances that differ from the chemical composition of the material or compound. Impurities that abruptly arise in quality control or other processes may deliver unexpected or even adverse effects on the development of products, especially medical devices and drugs.

In order to avoid the presence of unexpected impurity during the manufacturing process at most, it will be a great question to think about where is the impurity coming from. The result of this question, the origin of the impurity may also determine the guidelines or standards, as well as control limits for manufactures to follow in the final evaluation of the drug impurity.

What is Impurities Identification?

Impurity identification is the process of using a variety of analytical techniques to clarify the properties of unknown substances in drugs, medical devices, combination meidical products or consumer products. The three types of impurities that are usually evaluated during impurity identification are organic impurities, inorganic impurities and residual solvents. Identifying and describing the impurities is important for the development of products, as well as for safety reasons, since some impurities can be hazardous to the health of the person using the product.

Related Standards/ Guidelines

Various organizations such as the FDA and ICH gives out the guidance for identification of impurities as well as acceptable criteria for impurities qualification of impurities, qualification thresholds, and qualification procedures in a medical device or pharmaceutical product.

USP general chapter <1086> "Impurities in Drug Substances and Drug Products" and USP <476> "Organic Impurities in Drug Substances and Drug Products" provide regulations for pharmaceutical impurities.

USP <232> and <233> provide guidelines for elemental impurities

Outsourcing your Impurities Identification to STEMart

• Our Product Expertise
• Pharmaceutical Products (API, Drug Substance, Drug Product, etc.)
• Medical Devices
• Combination Medical Devices
• Consumer Products
• Our Analytical Techniques
• Chromatography: HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
• Spectroscopy: ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
• Microscopy: SEM, TEM, AFM, STM, LSCM
• Other: TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer

STEMart offers Impurities Identification services to medical device, pharmaceutical product, and consumer product industries with multiple technologies, following the guidance in various standards. Our Impurities Identification services include isolate, analyze, and identify impurities, in addition, we can develop and validate a method in order to help you monitor the impurity.

If you have additional questions about Impurities Identification or would like to find out more about our services, please feel free to contact us.