Impurity profile studies play significant roles in active pharmaceutical ingredient (API) development, which are closely related to the quality, safety and efficacy of drug products. And the impurity profile of API for drug products requires studying in the view of stringent quality standards. The recent guidelines published by International Conference on Harmonization (ICH) recommended identification and characterization of all the impurities present at a level of ~0.10% or more. Regulatory agencies give significant importance to quantifying the impurities present in the drug substance and also in the drug product. Hence impurities standards are required in pure form.
Figure 1. The content of enantiomeric contaminants
Pharmaceutical impurities are generally related to specific drugs and can be divided into organic impurities and inorganic impurities. Derived from the following aspects:
BOC Sciences can provide various types of methods to help you synthesize impurity, whatever group or chemical constitutions you want to introduce. We are expert at designing the routine and using multiple techniques (NMR, LCMS, GCMS, and X-ray) to analyze compounds after the impurity synthesis completed. Our advantages as following:
What is the method of determination of impurities?
Impurities are typically identified and quantified using analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), nuclear magnetic resonance (NMR), and infrared spectroscopy (IR). These methods provide both qualitative and quantitative impurity profiles.
How are impurities formed in chemical synthesis?
Impurities can arise from incomplete reactions, side reactions, degradation of starting materials or intermediates, contamination during processing, or residual solvents and reagents left after synthesis.
What are the common impurities in peptide synthesis?
In peptide synthesis, common impurities include deletion sequences, truncated peptides, racemized residues, aggregation products, and residual protecting groups. Careful optimization of synthesis and purification steps is required to minimize these byproducts.
What is the process of removing impurities called?
The process of removing impurities is known as purification. Techniques such as preparative chromatography, crystallization, distillation, and filtration are commonly used to isolate the target compound with high purity.
What impurity synthesis capabilities does BOC Sciences provide?
BOC Sciences offers custom synthesis of impurities and degradation products for use as reference standards in analytical method development, validation, and stability studies. Our capabilities cover organic compounds, peptides, APIs, and complex chemical structures.
We provide impurities synthesis with accurate structural confirmation and purity for method development and quality control.
Submit your inquiry to request a custom solution.
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