Description

Sitagliptin Impurity H Hcl is a high-purity chemical reference standard used in the pharmaceutical development and quality control of antidiabetic drugs. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by serving as a known impurity for analytical method validation and stability studies. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals involved in the production and compliance of sitagliptin-based medications.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Sitagliptin API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical R&D and QC laboratories.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time.
• Used for regulatory compliance and submission to agencies like the FDA, EMA, and ICH, providing necessary impurity data.
• Serves as a system suitability test component in chromatographic assays.
• Supports pharmacopoeial testing to meet USP/EP/JP monograph requirements for impurity limits.

Basic Information

Product Name	Sitagliptin Impurity H Hcl
CAS No.	1334244-24-4
Molecular Formula	C16H16F6N5O·HCl
Molecular Weight	477.78 g/mol
Synonyms	7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine Hydrochloride; Sitagliptin Related Compound H Hydrochloride; (3R)-3-Amino-1-[5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one Hydrochloride; Januvia Impurity H HCl; MK-0431 Impurity H HCl; Sitagliptin EP Impurity H HCl; Sitagliptin USP Impurity H HCl
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity H Hcl is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to support pharmaceutical applications, with testing typically including HPLC for assay and related substances, residual solvent analysis, and spectroscopic identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We can supply material compliant with various pharmacopoeial standards (USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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