1494079

Pancreatin lipase

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Pancreatin
• CAS Number: 8049-47-6
• MDL number: MFCD00131789
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• form: solid
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat

Description

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

Pancreatin lipase USP Reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:

• Pancreatin Tablets
• Pancreatin
• Pancrelipase Delayed-Release Capsules
• Pancrelipase Tablets
• Pancrelipase Capsules
• Pancrelipase

Unit Definition

One USP Unit of lipase activity is contained in the amount of pancreatin that liberates 1.0 µEq of acid per minute at a pH of 9.0 and 37° under the conditions of the assay for lipase activity.

Other Notes

This product is intended for use as a reference standard in pharmaceutical research and development. This product is for test and assay use only. It is not tested for animal or human consumption, clinical testing, or therapeutic use.

This product is part of the USP Biologics program.

Sales restrictions may apply.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Statements: H315,H317,H319,H334,H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Resp. Sens. 1 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable