Description

Linagliptin Impurity 16 is a designated impurity of the antidiabetic pharmaceutical agent Linagliptin, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Linagliptin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Linagliptin batches comply with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and marketing authorization.
• Process Chemistry Research: Aids in understanding and optimizing the Linagliptin synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Linagliptin Impurity 16
CAS No.	1955514-80-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linagliptin Related Compound 16; BI 1356 Impurity 16; 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione Impurity; Tradjenta Impurity 16; (R)-8-(3-Aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione Impurity
EINECS	Contact for details

Quality Control

Our Linagliptin Impurity 16 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We support compliance with ICH guidelines and major pharmacopeial standards, providing the traceability and documentation required for cGMP applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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