AMINO ACID ANALYSIS
Automatic Amino Acid Analyzer
There are different analytical methods that can be used to analyze amino acids, theAutomatic Amino Acid AnalyzerBiochrom 30 , however, unlike the others, including HPLC, satisfies the following requirements:
- Instrumentation compliant with IVDR Class directives of risk Medical Devices as per Annex VIII of EU Regulation IVDR 2017/746: Class A – Rule 5
- AOAC and the European Commission Directive 98/64/EC for the analysis of amino acids in food matrices, feed and fertilizers.
- Compliance with Decree No. 6890 of 28 April 2014 “Approval of the official analysis method for determining the content of free amino acids in cheeses”; Link to the publication
- Pharmacopoeia 5.0 - AMINO ACID ANALYSIS IN ACCORDANCE WITH PHARMACOPOEIA 5.0 method “2.5.56 Amino Acid Analysis method 1” (POST-COLUMN DERIVATIZATION WITH NINHYDRIN).
- New Phoenix Software Complies with 21 CFR Part 11
The Biochrom 30 is an instrument dedicated to the quantitative and qualitative analysis of all amino acids of physiological interest, using cation exchange chromatography with post-column derivatization using Ninhydrin.
Its use ranges from routine quality control to medical research projects, where a high degree of accuracy and reproducibility in analyses is required.
The BIOCHROM 30 is a fully automatic analyzer, specifically designed for the analysis of Amino Acids and capable of obtaining accurate and reproducible results.
The system and method are customized according to the specifications provided by the customer.
Biochrom, with over 25 years of experience in the sector, offers BIOCHROM 30 which brings together and exploits all the experience accumulated by the company in solving the needs and problems of users.
Below are the main new features introduced with the new version:
• New rapid methods for the analysis of amino acids (Lithium) with a 90-minute chromatogram for 48 amino acids, a program that allows you to save time (injection-injection) compared to classic working methods
• New rapid methods for amino acid analysis (Sodium) with 40 minute chromatogram for 24 amino acids, program that allows to save 33% of analysis time
• New refrigerated and insulated autosampler
• Improved analytical sensitivity
• Better reproducibility for area and retention time
Phoenix
Software di Gestione ed acquisizione dati conforme alle direttive CFR 21 Parte 11
- ICH Q6B - International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use)
- IQ/OQ – Installation Qualification and Operational Qualification (Documentation package installation performed on site by qualified engineer)
- ISO 17034 -- Relating to manufacturing of reference standards. Biochrom has the only ISO 17034 grade amino acid reference standards.
- Pharmacopoeia Compliance – Globally recognised set of directions of analytical methods to produce drugs
- 21 CFR Part 11 – FDA regulation on reliability on electronic records
-- Phoenix CFR software and OpenLab or Clarity data analysis package to ‘close the loop’.
