Description

Sitagliptin Ep Impurity B CAS NO 1345822-87-8 is a high-purity reference standard specifically used in the pharmaceutical quality control process. This compound is critical for the accurate identification, quantification, and monitoring of a specified impurity during the development and manufacturing of the antidiabetic drug Sitagliptin. It is an essential material for analytical laboratories and pharmaceutical manufacturers focused on ensuring product safety, efficacy, and regulatory compliance. The use of this well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements for drug substance and finished product specifications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Quality Control & Assurance: For the identification and quantification of Impurity B in Sitagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity profile data.
• Stability Studies: Used to monitor impurity levels in Sitagliptin formulations under various stress and storage conditions.
• Process Chemistry R&D: Aids in understanding and controlling the formation of this impurity during the synthetic pathway of Sitagliptin.
• Pharmacopeial Testing: Employed in testing to comply with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other international standards.

Basic Information

Product Name	Sitagliptin Ep Impurity B
CAS No.	1345822-87-8
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	(2R)-1-[2,5-Difluorophenyl]-4-[(3R)-3-amino-4-(2,4,5-trifluorophenyl)butanoyl]piperazine-2-carbonitrile; (R)-1-(2,5-Difluorophenyl)-4-((R)-3-amino-4-(2,4,5-trifluorophenyl)butanoyl)piperazine-2-carbonitrile; Sitagliptin Impurity B; Januvia Impurity B; MK-0431 Impurity B; Stereoisomer of Sitagliptin; Diastereomer of Sitagliptin
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Ep Impurity B is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials, supporting compliance with ICH Q3A/B guidelines and pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.