1A03330

Orlistat Open Ring Amide

Pharmaceutical Analytical Impurity (PAI)

• Synonym(s): reference material
• Empirical Formula (Hill Notation): C₃₇H₆₄N₂O₅
• Molecular Weight: 616.91
• UNSPSC Code: 41116107
• eCl@ss: 25140904

Properties

• grade: pharmaceutical analytical impurity (PAI)
• agency: USP
• form: semisolid
• manufacturer/tradename: USP
• color: colorless
• application(s): pharmaceutical small molecule
• format: neat
• storage temp.: 2-8°C

Description

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS 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

• Pharmaceutical QC release and stability testing. Identify and quantify Related Compound A in amisulpride drug substance and drug product.
• Manufacturing and process control. Monitor impurity levels from raw material through finished product.
• System suitability and peak identification. Confirm the position of the impurity peak and support chromatographic performance checks.
• Analytical method development and validation. Establish specificity, linearity, limits of detection and quantitation.

Features and Benefits

• Official USP Reference Standard. Provided as delivered and specified by the United States Pharmacopeia, and accompanied by documentation issued under USP′s authority.
• Backed by a trusted supply chain. It is available from MilliporeSigma with the global distribution and customer support, alongside a wide portfolio of USP standards.
• Confidence in compliance. A pharmacopeial standard supports your regulatory submissions and quality documentation, so your results rest on an accepted reference.
• Accurate impurity identification. An authentic reference lets you confirm retention time and identity, which reduces misidentification risk during method development and routine testing.

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

USP issued SDS can be found here

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Codes: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Eye Irrit. 2
• Storage Class: 11 - Combustible Solids
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable