1494057

Pancreatin amylase and protease

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Pancreatin
• CAS Number: 8049-47-6
• MDL number: MFCD00063077
• NACRES: NA.24
• UNSPSC Code: 41116107

Properties

• grade: pharmaceutical primary standard
• agency: USP
• form: powder
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule); pharmaceutical
• format: neat

Description

General description

Find answers to frequently asked questions on USP products in USP FAQs.

Pancreatin Amylase and Protease are enzymatic components derived from porcine pancreas. Amylase catalyzes the hydrolysis of starch into sugars, while protease facilitates the breakdown of proteins into peptides and amino acids. These enzymes are employed in digestive aid formulations.

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.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

One USP Unit of amylase activity is contained in the amount of pancreatin that decomposes starch at an initial rate such that 0.16 µEq of glycosidic linkage is hydrolyzed per minute under the conditions of the Assay for amylase activity. One USP Unit of protease activity is contained in the amount of pancreatin that under the conditions of the Assay for protease activity hydrolyzes casein at an initial rate such that there is liberated per minute an amount of peptides not precipitated by trichloroacetic acid that gives the same absorbance at 280 nm as 15 nmol of tyrosine.

This product is part of the USP Biologics program.

Disclaimer

Sales restrictions may apply.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Codes: 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: 11 - Combustible Solids
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable