Formulation Research of Ionic Components in Prescription

Most generic drugs are produced synthetically in bulk, and then formulated into small dosage forms such as tablets or injectables. Many of these substances are manufactured in specific salt forms to improve solubility, stability and bioavailability. For example, the most commonly used ions in basic drugs are chloride and sulfate. Therefore, accurate determination of the concentrations of these ionic components is important to determine the correct molecular weight of the Reference Listed Drugs (RLDs) drug, the stoichiometric relationship between the RLDs and the ionic components, and the integrity of the salt formation. However, these components are ionic or polar in nature, and lack the chromophores necessary for analysis by absorption measurements, making their detection and quantification a vexing problem. Alfa Chemistry provides ion chromatography (IC) and high performance liquid chromatography (HPLC) to determine the ionic compounds in the formulation of the RLDs to ensure the pharmaceutical equivalence between your manufactured generic drugs and the RLDs.

Figure 1. Flow chart of IC-CD analysis of H₃PO₃ in generic drugs. (Otto, S.; et al. 2022)

Our Services

IC - Amperometric Detector (IC-ED) Solution

IC with ED present a suitable technique for the determination of these ionic components. For cations in RLDs including monosaccharides and oligosaccharides, sugar alcohols, aminoglycosides (antibiotics), amino acids, peptides, organic acids, amines, alcohols, glycols, thiols, etc., we recommend Alfa Chemistry's advanced IC-ED analysis services.

Advantages of our IC-ED methods:

• Achieve excellent detection from high to low concentrations
• Excellent stability
• Support the selection of multiple wave forms and integration times to optimize individual analyte
• Flexible configuration for use in series with another detector or parallel for dual detection

IC - Conductivity Detector (IC-CD) Solution

Low molecular weight species such as amines and hydroxylamines in the RLDs are challenging to analyze using ultra-high performance liquid chromatography/mass spectrometry (UHPLC/MS) due to their high polarity resulting in poor retention. Ion chromatography is an emerging technique for the analysis of polar molecules that provides better separations. Alfa Chemistry provides high-quality IC analysis services to accurately identify ionic components in the RLDs.

Advantages of our IC-CD methods:

• High sensitivity across concentrations
• Achieve excellent detection from high to low concentrations
• Enhanced thermal stability
• Choice of capillary and analytical (standard and microbore) models
• Flexible configuration for use in series with another detector or parallel for dual detection
• Supports flow and volume optimization for capillary applications

HPLC/UHPLC - Charged Aerosol Detectors (HPLC/UHPLC-CAD) Solution

We offer HPLC and UHPLC universal detection services, with aerosol detectors to measure various analytes such as large and small molecules, biomolecules, etc. Our experts analyze ionic compounds in RLDs by adjusting pH, buffer strength and temperature to fully ionize analyte.

Advantages of our HPLC/UHPLC-CAD methods:

• Simple and repeatability
• Available for QC/QA applications
• Support the detection and quantitation of virtually any substance