南宫NG28

Service Background

In the pharmaceutical and food industries, fully automatic amino acid analysis and testing are crucial! Among them, the control of ninhydrin-positive substances and ammonium is the key to ensuring product quality, safety and functionality. The European Pharmacopoeia (EP) amino acid monographs have clearly required the use of Amino Acid Analyzer (AAA) method to determine ninhydrin-positive substances and ammonium. The fully automatic amino acid analysis service provided by CTI Pharma and Medical Services to provide customers with accurate and efficient testing solutions to meet industry standards and regulatory requirements.

Fully automatic amino acid analysis

1.  Fully automatic amino acid qualitative/quantitative analysis
Use Hitachi LA8080 high-speed automatic amino acid analyzer for qualitative and quantitative analysis. In addition to the European Pharmacopoeia (EP) and other national pharmacopoeias, suitable detection methods and conditions can be selected according to industry standards or customer-specific requirements.

2. Method development and validation
Customize specific amino acid organic impurity detection methods for customers, conduct strict validation, and provide a full set of parameter reports for method validation.

Applicable objects

● Pharmaceutical companies: for the detection of amino acids and their derivatives of APIs, intermediates and finished drugs.
● Scientific research institutions: for the analysis of amino acids and their derivatives.
● Various amino acids: Alanine, Histidine, Arginine, Tryptophan, Aspartic acid, Glycine, etc.

Our advantages

1. Professional scientific research team
The team consists of senior biochemists and analytical chemists, with profound professional knowledge and rich practical experience, ensuring the scientificity and authority of the analysis results;
2. Advanced experimental equipment
Adopt Hitachi LA8080 High-Speed Amino Acid Analyzer, equipped with sodium system and lithium system, to provide efficient and accurate testing services;
3. Strict quality control
Implement the cGMP system and implement strict quality control processes to ensure the authority of the test results;
4. Comprehensive amino acid coverage
According to domestic and foreign pharmacopoeias, industry standards, etc., dozens of amino acids are comprehensively and accurately determined, including but not limited to: Alanine, Histidine, Arginine, Tryptophan, Aspartic acid, Glycine, etc.
5. Customized service
According to the specific needs of customers, adjust the analysis parameters and methods, and shorten the detection cycle as much as possible to meet specific research and application scenarios.

Service process