Description

Rac-Sitagliptin Ep Impurity B Hcl is a high-purity chemical reference standard, specifically the hydrochloride salt of a stereoisomeric impurity related to the antidiabetic drug Sitagliptin. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily used by research institutions, quality assurance laboratories, and API producers focused on developing and monitoring the purity of Sitagliptin and related compounds.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments and validating testing methods in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS systems to establish retention times, identify impurity peaks, and develop robust separation protocols for Sitagliptin drug substance and product analysis.
• Quality Control & Assurance: Essential for routine batch testing to quantify and control the levels of this specific stereoisomeric impurity, ensuring final drug product safety and efficacy.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity profiles and justify specification limits for Sitagliptin.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways of Sitagliptin under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Rac-Sitagliptin Ep Impurity B Hcl
CAS No.	1334244-32-4
Molecular Formula	C16H16F6N5O·HCl
Molecular Weight	445.78 g/mol (Free base: 408.33 g/mol)
Synonyms	(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one hydrochloride; Sitagliptin EP Impurity B Racemate Hydrochloride; Sitagliptin Racemic Epimer B HCl; Sitagliptin Diastereomer Impurity B HCl; Januvia Impurity B Racemate HCl; (±)-Sitagliptin Ep Impurity B Hydrochloride; 7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo[4,3-a]pyrazine hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Rac-Sitagliptin Ep Impurity B Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single 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.