Formulation Research of Organic Components in Prescription

In recent years, the manufacturing and use of generic drugs has continued to increase, and has been widely recognized for a long time. The development and employment of excipients or APIs for the manufacture of generic drugs varies among pharmaceutical manufacturers, and many combinations have been produced. Therefore, the components in the Reference Listed Drugs (RLDs) need to be accurately analyzed. For the development of complex and consistently effective generic drugs, analysis of the RLD prescription is critical to determine the efficacy and safety. Many new drug candidates for the treatment of numerous diseases are organic compounds, and a lot of drugs in the market are small organic molecules. Fully investigation of the organic composition of the RLDs is very important for the development of generic drugs. As an important part of pharmaceutical equivalence evaluation, Alfa Chemistry provides identification and quantitative analysis services for organic compounds in the RLD formulations.

Figure 1. Relationship Between Drug Discovery and Organic Chemistry. (Grygorenko, O. O.; et al. 2019)

Our Services

Identification of Organic Compounds

Liquid Chromatography with Mass Spectrometry (LC/MS) Method

For the formulation analysis of the RLDs, LC/MS analysis is one of the most powerful analytical tools for the analysis of organic compounds, combining the physical separation ability of liquid chromatography with the mass analysis ability of mass spectrometry. Liquid chromatography methods are used to separate mixtures with multiple components in formulations, while mass spectrometry provides accurate structural characterization of individual components with high molecular specificity and detection capability.

Advantages of our LC-MS methods:

• Deliver full-spectrum, high-resolution and accurate-mass data
• For screening, analysis and identification of organics of various molecular weights: Capable of measuring molecular weights ranging from 120 Da to 22,000 Da
• Support the application of conjunction with HPLC-UV to determine the purity and subsequent molecular weight of each fraction, including relative isotopic abundance

High Performance Liquid Chromatography (HPLC)-UV Method

As one of the most common component analysis methods, HPLC technique brings an effective analysis method for the formulation research of organic components in pharmaceutical products. In addition to LC/MS analysis, we also provide simple, sensitive, cost-effective and time-saving HPLC-UV analysis services following the International Committee for Harmonization (ICH) guidelines for the validation of technical requirements for the registration of medicinal products for human use. Method validation of this method is performed by our experts to determine linearity, sensitivity, accuracy, and precision.

Identification of Volatile and Semi-volatile Organic Compounds in Liquid RLDs

We provide GC/MS analysis services to identify volatile and semi-volatile organic compounds in liquid RLDs. Alfa Chemistry's advanced analytical labs introduce headspace sampling and large volume liquid Injection to perform the identification of these organic compounds. Leachable organics are selected for further analysis based on their toxicological information: Single ion monitoring (SIM) technique is employed to further confirm the leachable organic compound.

GC/MS Analysis and Compound Identification

We provide characterization services for all volatile and semi-volatile organic compounds in the RLDs, with structure confirmation by matching mass spectra of all compounds to NIST libraries.