内毒素

• 除热原内毒素指示剂
• 枸橼酸镓67注射液
• 碘化钠I-131溶液
• 锝Tc-99m依地酸钙钠注射液
• 钇Y-90利妥昔单抗注射液
• 碘沙醇钠I-125注射液

• 按美国药典专论《去热原用内毒素指示剂》所示，用于内毒素的特性分析。
• 按照美国药典通则所示，在确认标记裂解物灵敏度的预试验中，用于制备标准溶液。
• 按USP-NF官方专论所示，在医药及相关行业中，这种高度表征的标准品可用于肽类药物的ID、强度、质量和纯度的测试。

Endotoxins are lipopolysaccharides located in the outer membrane of Gram-negative bacteria. They are potent pyrogens and can elicit strong immune responses, making their detection and quantification essential in pharmaceutical and medical device manufacturing to prevent adverse patient reactions.​

The USP Endotoxin standard provides a benchmark for the detection and quantification of bacterial endotoxins.

The USP biologics carbohydrates category includes a variety of carbohydrate-based substances that are essential in the development and manufacturing of therapeutic products. These carbohydrates play crucial roles in biological processes and are often utilized as excipients, stabilizers, or active ingredients in pharmaceuticals. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of carbohydrate therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.