Description

Dapagliflozin Impurity 13 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the SGLT2 inhibitor, Dapagliflozin. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) by enabling the accurate identification, quantification, and control of specific process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, supporting compliance with stringent regulatory guidelines from agencies like the FDA and EMA.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Dapagliflozin and related substances.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control the levels of this specific impurity in Dapagliflozin API batches to ensure they meet pharmacopeial specifications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Dapagliflozin.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections of NDA, ANDA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports process chemistry research aimed at minimizing or eliminating the formation of this impurity during API synthesis.

Basic Information

Product Name	Dapagliflozin Impurity 13
CAS No.	1938090-31-3
Molecular Formula	C21H25ClO6
Molecular Weight	408.87 g/mol
Synonyms	Dapagliflozin Related Compound 13; DAPA Impurity 13; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol; BMS-512148 Impurity 13; Forxiga Impurity 13; Farxiga Impurity 13; SGLT2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Dapagliflozin Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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