Relying upon its independently-developed PI System (high performance separation and purification-high performance pumps, high performance columns, high performance separation materials and methods) and efficient synthesis technology, and taking as its central work the manufacturing of drug impurities involved in the process of drug registration application, Guangzhou Pi & Pi Biotech Inc. provides drug R& D and manufacturing enterprises and institutes with comprehensive solutions to the efficient separation and custom synthesis of impurity reference substances in the process of drug R and D, and impurity problems in the process of registration application. Based on innovation and development, the company has won national, provincial and municipal support for establishment of many scientific research projects.
Whether the impurities in drugs are completely controlled or not has the direct bearing on the clinical safety of drugs and so impurity research and control is one of the important aspects of drug quality control research. PI&PI mainly supplies antibiotic drug impurity reference substances at present. In terms of antibiotics, most of them are products derived from semi-fermentation and semi-synthesis, and the kinds and content of impurities included in them are usually more complex than those of common synthesized chemical drugs and thus more comprehensive research of chemical characterization is needed.
The company now has a 1400 m2 space for research and development, which consists of the pilot-scale test laboratory in the Private Science and Technology Park and Laboratory 611 in the South China Centre for Innovative Pharmaceuticals. The company includes the quality control department, the synthesis department, the purification department, the pilot-scale test reaction area etc. which are equipped with 11 latest HPLC’s such as one Thermo-3000 UHPLC [DGLC-DAD-LCQ-ESI-MS(n=11)], one Thermo-3000 UPLC [CAD- VWD]，lots of Thermo-3000 UHPLC’s [DGLC-DAD or UV] etc. and more than 20 PI separation and purification systems. More than 35 employees holding bachelor’s degree, master’s degree and doctorate are engaged in research and development, manufacturing, sales and management work. All these show that the company has first-class laboratories, first-class equipment and first-class talents.
Based on many types of detection, the structure confirmation data of PI&PI impurity reference substances is full and exact, and can be used for the impurity identification and control in the process of drug registration application. The specific analytical methods for the chemical characterization of PI&PI impurity reference substances are as follows:
——HPLC purity detection, carried out according to pharmacopeias of different countries and satisfying the requirements of API’s and their impurities
——UV absorption spectrophotometry, the UV whole spectrograms are provided
——IR absorption spectrophotometry
——HD-MS，MS and MS-MS
——Thermal Gravimetric Analysis （TGA）
——HNMR quantitative analysis
——HPLC-CAD quantitative analysis
The above-mentioned chemical characterization analyses can free users from the ponderous structure confirmation research from lack of official sources of reference substances .