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Ensuring Purity for Chromatography in Pharmaceutical Analysis
An analytical technique, chromatography contributes significantly to the development and quality control of drug compounds.
Vials
Screw Caps
Crimp Caps
Septa
Chromatography helps guarantee the purity and potency of drug compounds, addressing the industry’s rigorous standards.
Choosing pharmaceutical cap liners depends on their compatibility with the contained substance as well as the level of security needed to prevent contamination of a sample.
Silicone
Provides a tight seal and is commonly used in septa and liners for pharmaceutical applications.
Butyl rubber
Known for its inertness and resistance to gasses.
Polytetrafluoroethylene (PTFE)
Offers chemical resistance and is often used in liners for aggressive chemicals.
Polyethylene (PE)
Known for its flexibility and chemical resistance.
Foil liners
Made of aluminum foil, offering excellent barrier properties against moisture and gasses.
Polypropylene (PP)
Provides excellent chemical resistance and is commonly used in caps and liners.
Quality and cleanliness of pharmaceutical chromatography supplies are paramount.
These consumables are components in the preparation and containment of samples. Vials, typically made of glass or plastic, hold the samples and solvents. Caps secure the vials, maintaining the integrity of the sample by preventing leaks and exposure to air, which could alter the sample’s composition. Septa, usually made of rubber or silicone, are fitted into the caps. They allow for the syringe needle to penetrate for sample injection or withdrawal while keeping a sealed environment. These supplies, though seemingly minor, significantly impact the reliability and reproducibility of chromatographic results. Their role is to safeguard the sample’s purity and stability, which is fundamental in obtaining consistent and trustworthy data in pharmaceutical analysis.
Chromatography is relevant at various stages of drug development and production.
In research and development, chromatography helps identify and quantify the active pharmaceutical ingredients (APIs) and impurities in drug formulations to help scientists understand the drug’s composition and assess its safety and efficacy. During the quality control phase, chromatography is used to check the purity of the final product and that each batch of medication meets the stringent regulatory standards set for pharmaceuticals. Chromatography also aids in drug stability testing, monitoring any changes in the drug’s composition over time under different environmental conditions. In the production of biopharmaceuticals, such as proteins and vaccines, chromatography is indispensable for the purification process. It separates the desired therapeutic compounds from a complex mixture of biological materials. This step is fundamental for obtaining a pure, effective, and safe product for medical use.
Various international organizations oversee and establish pharmaceutical chromatography regulations.
Protects public health by ensuring the safety and effectiveness of food, drugs, and medical devices.
Safeguards human health and the environment by setting and enforcing regulations for air, water, land, and waste management.
Works to achieve global harmonization for the development and regulatory requirements of pharmaceuticals.
Protects public and animal health in Europe by evaluating and supervising medicinal products for human and veterinary use.
Develops and publishes international standards for a wide range of products, services, and processes.
European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP)
Set quality standards for medicines and their ingredients.
