Description

Sitagliptin Impurity 1 CAS NO 823817-55-6 is a designated pharmaceutical impurity used as a critical reference standard in the quality control of Sitagliptin, an active pharmaceutical ingredient (API) for type 2 diabetes medication. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity during analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Sitagliptin Impurity 1 in Sitagliptin API and finished dosage forms.
• Analytical Method Development and Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) by providing impurity characterization data.
• Stability Studies: Employed to track the formation and level of this impurity under various stress conditions and throughout the drug product's shelf life.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Sitagliptin to minimize the formation of this impurity.

Basic Information

Product Name	Sitagliptin Impurity 1
CAS No.	823817-55-6
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 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; (R)-3-Amino-1-(5,6-dihydro-3-(trifluoromethyl)-7H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-(2,4,5-trifluorophenyl)butan-1-one; Sitagliptin Related Compound A; Januvia Impurity A; MK-0431 Impurity A; Desfluoro Sitagliptin; 7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-[1,2,4]triazolo[4,3-a]pyrazine
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a pharmaceutical reference standard. Each batch is characterized and controlled against a comprehensive specification, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity assessment by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided, supporting compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

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