Quality Control of Pharmaceutical Raw Materials: Purity and Strength

Why Raw Material Control is Important in Pharmaceuticals?

Raw materials control in the pharmaceutical industry

In the pharmaceutical industry, quality control of raw materials is an important phase in the production of effective and safe medicines. The purity and potency of raw materials determine the effectiveness of medicines and the safety of patients. That is why pharmaceutical manufacturers attach great importance to the quality control processes of raw materials.

Purity analysis in the pharmaceutical industry

The purity of raw materials is assessed to determine the presence of unwanted impurities. Purity analysis is carried out using the following methods:

1. Chromatographic methods
• High-performance liquid chromatography (HPLC): Widely used to determine the composition of substances and levels of impurities.
• Gas chromatography (GC): Used for the analysis of volatile components.
• Thin-layer chromatography (TLC): Preferred for qualitative analysis.
2. Spectroscopic methods
• UV-Vis spectroscopy: Analyzes the purity of raw materials based on their absorption properties.
• Fourier Transform Infrared Spectroscopy (FTIR): Used to determine functional groups.
• Nuclear Magnetic Resonance (NMR): Used for structural analysis.
3. Chemical titration methods
• Acid-base titration: Used to quantify certain compounds.
• Complexometric titration: Preferably used to measure the presence of metal ions as impurities.

Potency analysis in the pharmaceutical industry

The potency of pharmaceutical raw materials is tested to determine their pharmacological effect. Potency analysis is done using the following methods:

1. Biological tests
• Cell culture tests: Effects on cells are evaluated.
• Animal model tests: The pharmacodynamic properties are examined.
2. Chemical analysis methods
• HPLC and GC analyses: Used to measure the concentration of the active ingredient.
• Spectrophotometric methods: Potency is evaluated by measuring absorption at specific wavelengths.
3. Pharmacokinetic evaluations
• Solubility tests: Used to understand the biological availability of the drug.

• Stability tests: Determines whether efficacy is maintained over time.

Quality control of raw materials for medicines is a critical process to guarantee the safety, efficacy and stability of medicines. Purity and potency is one of the most important parameters in the quality control of pharmaceutical raw materials. These controls must be carried out in accordance with pharmaceutical standards and requirements of regulatory authorities (FDA, EMA, USP, EP). Therefore, you should contact accredited and expert laboratories.

Nanolab Laboratories Group continues to provide services in the field of Pharma Analysis. You can also consult us about Nitrosamine Analysis.

Please contact us for more information.

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