Description

Linagliptin Impurity 30 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antidiabetic drug Linagliptin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by monitoring and controlling potential process-related substances. It is essential for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Linagliptin API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) to establish specificity, accuracy, and detection limits.
• Quality Control & Assurance testing in GMP manufacturing environments to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies to track impurity profiles and degradation pathways of Linagliptin under various storage conditions.
• Regulatory Submissions, providing essential data for Drug Master Files (DMFs), ANDAs, and other compliance documentation.
• Research and Development of Linagliptin synthesis processes to understand and minimize impurity formation.

Basic Information

Product Name	Linagliptin Impurity 30
CAS No.	2074688-81-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	BI-1356 Impurity 30; 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione; Tradjenta Impurity 30; Linagliptin Related Compound 30; (R)-8-(3-Aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione
EINECS	Contact for details

Quality Control

Every batch of Linagliptin Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) containing detailed analytical results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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