1494079

Pancreatin lipase

United States Pharmacopeia (USP) Reference Standard

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

Properties

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

Description

General description

Pancreatin lipase is a substance containing enzymes, principally lipase, with amylase and protease. This product Pancreatin lipase USP reference standard is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

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