Description

Sitagliptin Impurity 12 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sitagliptin. This compound is critical for ensuring the safety and efficacy of pharmaceutical formulations by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the development and manufacturing of antidiabetic medications.

Application

• Primary use as a certified reference standard for the analytical validation of Sitagliptin API.
• Critical component in method development and validation for HPLC, UPLC, and LC-MS impurity profiling.
• Used for pharmacopeial compliance testing (e.g., USP, EP, ICH guidelines Q3A(R2) and Q3B(R2)).
• Essential for stability studies and forced degradation studies to monitor impurity formation.
• Serves as a system suitability test component in routine QA/QC release testing of Sitagliptin batches.
• Valuable for regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and control strategies.
• Used in academic and industrial research on the synthesis, metabolism, and degradation pathways of Sitagliptin.

Basic Information

Product Name	Sitagliptin Impurity 12
CAS No.	1803026-54-1
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 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; 1-[[(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]amino]acetyl-2-(2,5-difluorophenyl)-4,5-dihydro-1H-pyrrole; Sitagliptin Related Compound 12; Januvia Impurity 12; MK-0431 Impurity 12; DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles as per ICH guidelines. We support compliance with cGMP and relevant pharmacopeial standards (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed 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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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