Description

Sitagliptin n-Boc Impurity CAS NO 486460-23-5 is a high-purity chemical reference standard used in the analytical profiling and quality control of Sitagliptin, a leading anti-diabetic pharmaceutical. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification during the manufacturing process. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on developing and producing high-quality active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of the n-Boc protected impurity in Sitagliptin API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in Sitagliptin under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Sitagliptin to minimize the formation of this specific impurity.

Basic Information

Product Name	Sitagliptin n-Boc Impurity
CAS No.	486460-23-5
Molecular Formula	C23H34F3N5O3
Molecular Weight	485.55 g/mol
Synonyms	(3R)-3-Amino-4-(2,4,5-trifluorophenyl)-N-{[1-(tert-butoxycarbonyl)-4-(2-pyrimidinyl)-4-piperazinyl]methyl}butanamide; tert-Butyl 4-({[(2R)-4-(2,4,5-trifluorophenyl)-1-oxo-4-[(pyrimidin-2-yl)piperazin-1-yl]butan-2-yl]carbamoyl}methyl)piperazine-1-carboxylate; Sitagliptin tert-Butyloxycarbonyl Impurity; Sitagliptin Boc-Protected Impurity; Sitagliptin Related Compound; Januvia Impurity; MK-0431 Impurity
EINECS	Contact for details

Quality Control

Our Sitagliptin n-Boc Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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