UV‑Visible Spectrophotometer Qualification Services

The UV‑Visible spectrophotometer is a core laboratory instrument used to measure the ultraviolet light absorption of chemical compounds and pharmaceutical products. It is a fundamental tool in the pharmaceutical industry and drug quality control processes.

In pharmaceutical applications, UV spectrophotometry determines UV light absorption as a quality control method for assessing drug purity and chemical composition. It is also used to accurately determine the concentration of active pharmaceutical ingredients (APIs).

By comparing a sample’s UV absorption with defined quality standards, researchers and manufacturers can ensure compliance with specifications and confirm that products deliver their intended therapeutic effects. This makes the UV‑Vis spectrophotometer essential for guaranteeing purity, correct chemical composition, and compliance with quality standards.

Our company conducts UV‑Vis spectrophotometer qualification in strict accordance with EDQM Annex 3, USP <857>, and other pharmaceutical protocols.

Service Scope & Documentation:

• Pre‑assessment: Review of existing documentation, needs analysis, and free consultation
• Installation Qualification (IQ): Protocol development and documentation to confirm proper installation
• Operational Qualification (OQ): Test execution, protocol completion, and performance verification under controlled conditions
• Performance Qualification (PQ): Test execution and documentation to confirm analytical performance in real working conditions

Fourier Transform Infrared Spectrophotometer (FT‑IR) Qualification Services

The FT‑IR spectrophotometer is another key analytical instrument in the pharmaceutical industry, used for qualitative and quantitative identification of chemical compounds and drug products.

By analyzing near‑infrared fingerprint patterns, FT‑IR spectroscopy helps determine material composition, detect impurities, and verify product integrity. This technique ensures that manufactured pharmaceutical products meet required purity and quality levels. It is also suitable for monitoring changes in chemical composition during production and stability studies.

Our company performs FT‑IR qualification based on EDQM Annex 4 protocols. Given the increasing use of FT‑IR for quantitative applications in pharma, quantitative qualification tests are also performed in accordance with Thermo Scientific protocols (USA). Full ATR sampling system qualification is likewise included.

Service Scope & Documentation:

• Pre‑assessment: Review of existing documentation, needs analysis, and free consultation
• Installation Qualification (IQ): Protocol preparation and verification of proper system setup
• Operational Qualification (OQ): Execution of standard tests and verification of correct instrument function
• Performance Qualification (PQ): Execution of performance tests, including quantitative analysis validation, and full ATR module testing