Assay Testing
Assay testing plays a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products by accurately quantifying the active pharmaceutical ingredient (API). In this article, we'll explore the significance of assay testing, the methods used for analysis, and why it's essential for pharmaceutical manufacturers and regulatory compliance.
Assay testing involves the quantification of the active pharmaceutical ingredient (API) in a pharmaceutical formulation. It verifies the concentration of the API to ensure that it meets specified quality standards and provides the intended therapeutic effect to patients.
Our Methods
Several methods are used for assay testing, depending on the nature of the pharmaceutical product and the properties of the active ingredient:
-
Titration Methods
Titration techniques, such as acid-base titration or complexometric titration, are commonly used for assay testing of substances with known chemical reactions. -
Chromatographic Techniques
High-performance liquid chromatography (HPLC) and gas chromatography (GC) are widely employed for assay testing due to their high sensitivity, selectivity, and accuracy.
-
Spectroscopic Methods
Spectroscopic techniques, including UV-visible spectroscopy and infrared (IR) spectroscopy, are utilised for quantifying API concentrations based on their characteristic absorption or emission spectra.
-
Gravimetric Methods
Gravimetric methods involve the measurement of mass changes to determine the concentration of the active ingredient, particularly for solid dosage forms.
Conducting Assay Testing
The process of assay testing involves several key steps:
1. Sample Preparation: The pharmaceutical sample is prepared according to standardised procedures, ensuring homogeneity and representativeness.
2. Method Validation: The assay method is validated to confirm its accuracy, precision, specificity, and robustness.
3. Instrument Calibration: Analytical instruments are calibrated using certified reference standards to ensure accuracy and reliability of results.
4. Analysis: The prepared sample is analysed using the selected assay method, and the concentration of the active ingredient is determined based on calibration curves or standard addition methods.
At Tentamus Pharma UK, we are committed to providing Assay Testing Services. Our goal is to support the pharmaceutical industry in delivering safe, effective, and high-quality products to the market.
Feel free to contact us by filling out our contact form.