Chondroitin sulfate (CS) and glucosamine (GLcN) are recommended for the restoration of the articular cartilage surface in patients affected by osteoarthritis. They are commercialized as pharmaceutical-grade products and as food supplements, and there are reports that they do not undergo the strict quality controls of pharmaceuticals. Herein, we evaluated the physicochemical parameters of two raw materials (CS and GlcN) obtained from two distinct suppliers in Brazil and compare the obtained data with the product specification provided by the manufacturer. Also, the homogeneity and purity grade of samples were analyzed by FT-IR spectroscopy. The organoleptic properties and solubility of CS and GlcN samples obtained from pharmacy analyses and the supplier’s specifications are in accordance with the standards required by the Brazilian Health Regulatory Agency (ANVISA). However, the intraclass correlation coefficient (ICC) and Bland Altman analysis of pH and the density values of samples are statistically different between the suppliers. In addition, FT-IR analyses indicated that there is non-homogeneity in the CS and GlcN samples tested, showing that both manufacturers distribute the drugs in different concentrations, although both declare the same concentration in the product technical specifications. In summary, our study demonstrated that physicochemical parameters are insufficient to ensure product quality, and it is necessary to implement a more efficient protocol to ensure the quality of the final product.

中文翻译：

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傅里叶变换红外光谱，硫酸软骨素和葡萄糖胺的理化特性作为原料质量控制的辅助信息

建议将硫酸软骨素（CS）和葡萄糖胺（GLcN）用于恢复患有骨关节炎的患者的关节软骨表面。它们被商业化为药品级产品和食品补充剂，并且有报道称它们没有经过严格的药品质量控制。在这里，我们评估了从巴西两个不同的供应商处获得的两种原材料（CS和GlcN）的理化参数，并将获得的数据与制造商提供的产品规格进行了比较。另外，通过FT-IR光谱分析了样品的均质性和纯度等级。通过药房分析获得的CS和GlcN样品的感官特性和溶解度以及供应商的规格符合巴西卫生监督局（ANVISA）要求的标准。但是，供应商之间的类内相关系数（ICC）和pH值的Bland Altman分析以及样品的密度值在统计上是不同的。此外，FT-IR分析表明，所测试的CS和GlcN样品中存在非均质性，表明两家制造商以不同浓度分配药物，尽管两家公司在产品技术规格中声明的浓度相同。总而言之，我们的研究表明，理化参数不足以确保产品质量，