Description

Lubiprostone Related Compound 3 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Lubiprostone through precise analytical control. It serves as an essential tool for scientists and quality control professionals in the pharmaceutical and biotechnology industries. Its primary role is in method development, validation, and impurity profiling during drug manufacturing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material for the identification and quantification of specific impurities in Lubiprostone API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure regulatory compliance.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor and control the purity of Lubiprostone drug substance and finished products.
• Stability Studies: Used to track the formation of related substances in Lubiprostone formulations under various stability-indicating conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Contract Research and Manufacturing (CRO/CMO): A vital reagent for third-party laboratories providing analytical and manufacturing services to the pharma industry.

Basic Information

Product Name	Lubiprostone Related Compound 3
CAS No.	1263283-38-0
Molecular Formula	C20H32F2O5
Molecular Weight	390.47 g/mol
Synonyms	Lubiprostone Impurity 3; Lubiprostone Related Substance 3; (2S,4R)-4-[(1R,2R)-2-[(3S)-3-[(1S)-1,1-Difluoropentyl]-3-oxopropoxy]-5-phenylpentyl]-2-[(E)-3-phenylprop-2-enoyl]oxy-3,4-dihydro-2H-pyran-5-carboxylic Acid; Amitiza Related Compound 3; SPI-0211 Related Compound 3; RU-0211 Related Compound 3
EINECS	Contact for details

Quality Control

Every batch of Lubiprostone Related Compound 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities. Identity, purity, and impurity content are confirmed using advanced spectroscopic and chromatographic techniques. A comprehensive Certificate of Analysis (COA) detailing all test results, including HPLC purity, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.