Pharmaceutical Identification

The identification test of pharmaceuticals is based on the composition, structure and properties of pharmaceuticals, using chemical, physical and chemical or biochemical methods to judge the authenticity of pharmaceuticals. Only when the pharmaceutical identification is correct, it is meaningful to check the impurities and content of the pharmaceutical. APIs should also be confirmed in combination with appearance, properties, solubility and physical constants. As a professional reliability third-party testing organization, T,C&A Lab can perform pharmaceutical identification according to ISO, FDA and other standards as well as industry requirements. Welcome to contact our experts for consultation.

Our pharmaceutical product identification services

• It is only suitable for identifying the authenticity of pharmaceutical products.
• It is a confirmatory test of a known pharmaceutical product.
• The identification test is individual analysis.
• When identifying pharmaceutical products, the interference of excipients in the preparation should be eliminated.

Our identification methods include but are not limited to

• Chemical identification methods, including color reaction identification, precipitation formation reaction identification, fluorescence reaction identification, gas generation reaction identification, reagent fading identification.
• Spectral identification, including infrared spectrophotometry and ultraviolet-visible spectrophotometry.
• Chromatographic identification, including thin layer chromatography, paper chromatography, high performance liquid chromatography and gas chromatography.
• Biological method, the use of biological methods to identify pharmaceuticals.

Our test cases include but are not limited to

• The identification of vitamin C, vitamin C has two chiral C atoms in the molecule, so it has optical rotation, which can be identified by measuring the optical rotation.
• Ninhydrin reaction, α-amino acids, primary amines and certain hydroxylamine pharmaceuticals can react with ninhydrin when heated to produce purple, blue or magenta products. The colored substance is not a single compound, but a condensation product of several mixture.

Standards we test to

ISO 11616, ISO/TS 20451, ISO/TS 20440, ISO 11238, ISO 11239, ISO 11240

In addition, the experts in our Pharmaceuticals Identification Laboratory also provide a variety of custom services as your needs and requirements. Let's discuss the custom services with our experts for free.

Instruments and data

Reference

1. https://microbenotes.com/ninhydrin-test/

Note: this service is for Research Use Only and Not intended for clinical use.

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