Compliance of Materials Used in Chromatography Vials with Pharmaceutical Safety and Purity Standards
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Compliance of Materials Used in Chromatography Vials with Pharmaceutical Safety and Purity Standards

Apr. 8th, 2024
When discussing the choice of material for a chromatography vial, one should consider whether it meets the standards for drug safety and purity that are important for laboratory work. Chromatography bottles are typically made of glass or plastic, but each material has its advantages and limitations, so several factors should be considered when making your choice.

First, let's look at glass chromatography bottles. Glass offers excellent chemical inertness and stability, making it less prone to chemical attack or dissolution, which helps maintain the purity and quality of the drug product. Glass chromatography bottles also have excellent transparency and optical properties, allowing you to clearly observe the state and changes in your sample. For this reason, glass chromatography bottles have become one of the preferred containers in many laboratories. However, glass chromatography bottles are relatively brittle and can be easily broken if subjected to strong shocks or temperature changes, so care must be taken when using and storing them.

Four Part of the Vial

Glass Vials

Glass vials are the most commonly used material in chromatography because they are inert and can withstand a wide range of temperatures. Borosilicate glass is especially preferred because of its resistance to chemical interactions that may affect sample integrity. These vials usually meet the standards set by regulatory agencies such as the United States Pharmacopeia (USP) and European Pharmacopeia (Ph. Eur.) for extractables and leachables, minimizing the impact on sample purity.

Plastic Vials

Polymeric materials such as polypropylene (PP) and polyethylene terephthalate (PET) are also used for chromatography vials, especially for applications where glass is not suitable, such as bioanalytical assays. However, when plastic vials are used, careful consideration must be given to solvent and sample compatibility to prevent leaching of contaminants. Manufacturers should ensure that these plastic vials meet regulatory standards relevant to pharmaceutical applications, including guidelines for extractables and leachables as specified by USP and Ph.

Silicone/PTFE Septum

Septums that seal chromatography vials are often made of silicone or polytetrafluoroethylene (PTFE). These materials must also comply with safety and purity standards to prevent sample contamination. Silicone septums are preferred for their inertness and durability, while PTFE septums offer superior chemical resistance. Both types must meet regulatory requirements for extractables, leachables, and biocompatibility.

Crimp Caps and Screw Caps

Caps used to seal chromatography vials are typically made of aluminum or plastic. Aluminum crimp caps are often used to provide a tight seal and prevent evaporation and contamination. Plastic screw caps, on the other hand, offer ease of use and are suitable for applications where vials must be opened and closed frequently. To ensure sample integrity, caps, regardless of material, must meet standards for purity and compatibility with the vial material.

Learn how to choose between Crimp Vial, Snap Vial, and Screw Cap Vial options in this insightful article:Crimp Vial vs. Snap Vial vs. Screw Cap Vial, How to Choose?

5 Factors should be Considered

Chemical inertness and reactivity

Glass is relatively chemically inert, but some plastics can react with certain chemicals. Therefore, it is important to select the appropriate material based on the needs of the experiment and the agent or chemical being used.

Heat and pressure resistance

If your experiment requires high temperature or high pressure conditions, the chromatography bottle material should have excellent heat and pressure resistance to prevent deformation or damage to the bottle.

Transparency and optical properties

Transparency and optical properties are important factors in experiments that require clear observation of sample condition and color changes.

Impact and leak resistance

Chromatography bottles must have excellent impact resistance to avoid liquid fluctuations and splashing during transport and operation. At the same time, the bottle cap and seal design must guarantee leak-proof performance.

Easy cleaning and corrosion resistance

The chromatography bottle material should be easy to clean and have good corrosion resistance to ensure a clean environment inside the bottle and avoid contamination by chemical residues.

When considering chromatography vial materials to meet pharmaceutical safety and purity standards, factors such as chemical inertness and reactivity of the material, temperature and pressure resistance, clarity and optical properties, impact and leak resistance, ease of cleaning, and corrosion resistance should also be considered. Gender and other factors. By comprehensively considering these factors, selecting the appropriate chromatography bottle material, and strictly following instructions and operating procedures for use and maintenance, the quality and purity of the drug product can be effectively protected, ensuring the accuracy, reliability, and safety of the experimental results.

Discover comprehensive answers to 50 questions about HPLC vials in this informative article:50 Most Frequently Asked Questions on HPLC Vials