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Technology Research of Applications of Nirs on Heparin Quality Control

Author: SunChunXiao
Tutor: ZuoHengChang；GuoXuePing
School: Shandong University
Course: Pharmaceutical Engineering
Keywords: near infrared spectroscopy heparin potency oversulfated chondroitin sulfate quality control
CLC: TQ463.6
Type: Master's thesis
Year: 2010
Downloads: 249
Quote: 1
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Abstract


Heparin is a primary implemented anticoagulant used for life-saving medical therapies, which is a polydisperse mixture of polysaccharides formed by disaccharide repeating units of glucuronic-iduronic acid linked to glucosamine, belonging to the family of glycosaminoglycans.There have been a number of reports of adverse responses in february of 2008 relating to contaminated heparin solutions and oversulfated chondroitin sulfate (OSCS) was found to be the contaminant representing up to approximately 30% wt/wt in suspect heparin samples. Lots of methods were then reported to determine OSCS in heparin, such as capillary electrophoresis (CE), nuclear magnetic resonance (NMR), cellulose acetate plate membrane/plate (CAM/P) method, infrared spectroscopy (IR), high performance liquid chromatography (HPLC) and so on.FDA considers that quality should depend on process design but not detection. And FDA introduced process analytical technology (PAT) manual in 2004, which encourages modern process analysis and monitoring technology entering every step of production process. And PAT could decrease production risks to minimum and strengthen competition of industry through increasing comprehension and valid control of production process.Under the background, it is essential to introduce on-line control to production process of heparin. However, all those analytical methods above need sample pretreatments, causing reagents consuming and contamination to some degree, thus, it is impossible to detect heparin online by the above methods. Nowadays near infrared spectroscopy (NIRS) have developed to one of the most process analytical technology. And NIRS is a modern analysis technology depending on chemometrics and computer technology, which could carry out qualitation and quantitation analysis to organic materials. As a fast and non-destructive method, NIRS has been reported to be successfully applied in pharmaceutical industries.Potency and impurities contents are important parameters representing heparin quality, thus we constructed potency analysis models of crude and pure heparin samples and impurities models of pure heparin samples. And we have investigated the impacts of different spectral pretreatment methods, division of calibration/prediction samples and spectral regions on performance of models. What is more, models for identifying contamination of heparin with OSCS and quantifying OSCS in heparin were also constructed by "addition method", namely OSCS was added into heparin. PLS Components (PCs), correlation coefficient of calibration set (Rc), the root mean square-of cross-validation (RMSECV) and correlation coefficient of prediction set (Rp), the root mean square of prediction (RMSEP) were used to evaluate the performance of the models. The overall results demonstrated that it is potential to detect potency of heparin and identify contamination of heparin with OSCS in heparin by NIRS with PLS algorithm, thus this method could be chosen as source and ending judgement technology in quality control (QC) department in heparin industry.We have made design of applying NIRS to alcohol precipitating step, and it is a long way to go for process control of glycosaminoglycans by NIRS.Major achievements:1 Potency analysis models of crude and pure heparin samples were constructed, and impacts of different spectral pretreatment methods, division of calibration/prediction samples and spectral regions on performance of models were investigated.2 Models for identifying contamination of heparin with OSCS and quantifying OSCS in heparin were also constructed by "addition method", and spectral regions on performance of models were investigated.3 Design of applying NIRS to alcohol precipitating step was made.

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CLC: > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > Production of organic compounds in drug > Elements of organic compounds in drug
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