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Merck
CN

1494057

USP

Pancreatin amylase and protease

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Pancreatin

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About This Item

CAS Number:
8049-47-6
MDL number:
MFCD00063077
UNSPSC Code:
41116107
NACRES:
NA.24

Key Documents

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grade

pharmaceutical primary standard

form

powder

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

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General description

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.

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H315,H317,H319,H334,H335

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 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

低风险生物材料
动植物源性产品

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B N P Sah et al.
Journal of dairy science, 99(6), 4233-4242 (2016-03-21)
The search for alternative therapeutics is on the rise due to the extensive increase in bacterial resistance to various conventional antibiotics and side effects of conventional cancer therapies. Bioactive peptides released from natural sources such as dairy foods by lactic
Pancreatin
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 3379-3379 (2013)
Pancrelipase
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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