Description

Sitagliptin Ep Impurity B Hcl is a high-purity chemical reference standard critical for pharmaceutical analysis and quality control. This compound serves as a specified impurity in the synthesis and purification of Sitagliptin, a leading active pharmaceutical ingredient (API) for type 2 diabetes treatment. It is essential for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sitagliptin and related drug substances.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in accordance with ICH guidelines.
• Quality Control (QC) and Quality Assurance (QA): Employed as a system suitability standard and for setting impurity limits in the release testing of Sitagliptin API and finished dosage forms.
• Regulatory Submissions and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Sitagliptin.
• Research and Development (R&D): Facilitates process chemistry research aimed at minimizing impurity formation and optimizing synthetic pathways for Sitagliptin.

Basic Information

Product Name	Sitagliptin Ep Impurity B Hcl
CAS No.	486459-70-5
Molecular Formula	C16H15F6N5O • HCl
Molecular Weight	467.77 g/mol (Free base: 431.32 g/mol)
Synonyms	(2R)-1-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6-dihydro-1H,3H-pyrrolo[1,2-c]imidazol-7-ium chloride; Sitagliptin EP Impurity B Hydrochloride; (R,R)-Sitagliptin Impurity B HCl; Januvia Impurity B HCl; MK-0431 Impurity B Hydrochloride; Sitagliptin Diastereomer Impurity B HCl; 5,6-Dihydro-1H,3H-pyrrolo[1,2-c]imidazol-7-ium, 1-[(3R)-3-amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-, chloride, (2R)-
EINECS	Contact for details

Quality Control

Every batch of 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 analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Assay (on dried basis)	97.0% - 103.0%

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