Description

Dapagliflozin Mono Acetyl Impurity is a key process-related impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dapagliflozin. Its precise characterization is critical for ensuring the purity, safety, and regulatory compliance of the final SGLT2 inhibitor drug product. This high-purity standard is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of antidiabetic medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the mono acetyl impurity in Dapagliflozin API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to monitor and control this specific impurity.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure Dapagliflozin batches meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability studies of the API.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Dapagliflozin to minimize the formation of this impurity.

Basic Information

Product Name	Dapagliflozin Mono Acetyl Impurity
CAS No.	1632287-34-3
Molecular Formula	C23H25ClO7
Molecular Weight	448.90 g/mol
Synonyms	(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-O-acetyl-D-glucitol; Dapagliflozin Acetyl Impurity; Dapagliflozin Monoacetate Impurity; Dapagliflozin Related Compound C (Mono Acetyl); BMS-512148 Mono Acetyl Impurity; Forxiga Mono Acetyl Impurity; Farxiga Mono Acetyl Impurity; SGLT2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Dapagliflozin Mono Acetyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance profiling, and structural confirmation (IR, NMR, MS) to ensure identity, strength, quality, and purity. A comprehensive Certificate of Analysis (COA) detailing all test results against predefined specifications is provided with every shipment to support your GMP and regulatory compliance requirements.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.