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Merck
CN

1494079

USP

胰脂肪酶

United States Pharmacopeia (USP) Reference Standard

别名:

Pancreatin Lipase

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化学文摘社编号:
MDL number:
NACRES:
NA.24
UNSPSC Code:
41116107
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General description

Pancreatin Lipase is a lipolytic enzyme obtained from porcine pancreas. It catalyzes the hydrolysis of dietary triglycerides into monoglycerides and free fatty acids, aiding in lipid digestion. This enzyme is used in the treatment of exocrine pancreatic insufficiency.

The USP biologics proteins category provides critical standards and reference materials necessary for the development and manufacturing of therapeutic proteins. These proteins, which can be naturally derived or genetically engineered, are essential in treating various diseases and conditions, ensuring that they meet quality, safety, and efficacy standards.

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.

Application

胰酶脂肪酶USP参考标准品的预期用途是美国药典(USP)规定的指定质量测试和检测。也用于下列USP专论:
  • 胰酶片
  • 胰酶
  • 胰脂肪酶肠溶胶囊
  • 胰脂肪酶片
  • 胰脂肪酶胶囊
  • 胰脂肪酶

Other Notes

1个USP脂肪酶活性单位是指在脂肪酶活性检测条件下,pH 9.0、37°下,每分钟释放1.0 µEq酸所需的胰酶量。
可能适用相应的销售限制。
该产品可用作药物研究和开发中的参考标准品。本品仅供测试和分析使用。不适用于动物或人类食用、临床测试或治疗用途。
该产品是美国药典生物制品计划的一部分。

pictograms

Health hazardExclamation mark

signalword

Danger

Hazard Classifications

Eye Irrit. 2 - Resp. Sens. 1 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3

target_organs

Respiratory system

存储类别

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

动植物源性产品
低风险生物材料
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历史批次信息供参考:

分析证书(COA)

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Pancreatin
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 3379-3379 (2013)
Pancrelipase
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 3382-3382 (2013)
Yangchao Luo et al.
Food chemistry, 155, 146-154 (2014-03-07)
Sodium caseinate (NaCas) was hydrolyzed by papain, pancreatin and trypsin from 10 min to 24h, and the hydrolysates were partially characterized for several important properties. At the studied conditions, papain and trypsin were more effective in hydrolyzing NaCas than pancreatin.

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