Description

Sitagliptin Impurity 35 is a high-purity chemical reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of drug products by enabling the accurate identification and quantification of specific process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Sitagliptin, a leading medication for type 2 diabetes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Sitagliptin API and finished dosage forms.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for the identification, characterization, and quantification of impurity profiles during stability studies and forced degradation studies.
• Regulatory Compliance: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Chemistry: Aids in the optimization of synthetic routes and purification processes by tracking the formation and clearance of this specific impurity.
• Quality Assurance/Control: Employed as a system suitability component and for calibrating analytical instruments to ensure accurate and reliable impurity detection limits.

Basic Information

Product Name	Sitagliptin Impurity 35
CAS No.	945261-47-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(7R)-7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-7,8-dihydro-8-oxo-1,3-dihydro-2H-imidazo[4,5-c]azepin-2-one; Sitagliptin Related Compound 35; Januvia Impurity 35; MK-0431 Impurity 35; DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 35 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 industry standards for reference materials. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and available upon request 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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. Ensure the container is sealed tightly after each use to prevent degradation.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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