Description

Dapagliflozin Impurity 14 is a high-purity reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the development and manufacturing of the active pharmaceutical ingredient (API) Dapagliflozin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling. Ensuring the integrity of this impurity standard is fundamental to maintaining the safety and efficacy of the final drug product.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Dapagliflozin API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure impurity levels are within ICH and pharmacopeial limits (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to monitor the formation and growth of this specific impurity under various stress and storage conditions.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to support process optimization and scale-up.

Basic Information

Product Name	Dapagliflozin Impurity 14
CAS No.	2271248-78-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 14; Dapagliflozin EP Impurity J; Dapagliflozin USP Impurity; Forxiga Impurity 14; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol Impurity; SGLT2 Inhibitor Impurity; BMS-512148 Impurity 14
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity 14 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 techniques such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia guidelines for impurities in new drug substances and products.

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 inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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