CAS number: 461432-26-8
Therapeutic segment: Antidiabetic / Glycemic Control
API class/drug class: Sodium–glucose co-transporter 2 (SGLT2) inhibitor
Chemical name: (2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
Molecular formula: C21H25ClO6
Molecular weight: 408.9 g/mol
Form: White to off-white crystalline powder or solid
Packaging type: Double LDPE bags packed in HDPE drums or equivalent pharma-grade, moisture-protective packaging
Storage conditions: Store at 20°C to 25°C (68°F to 77°F). Keep in a tightly closed container, protected from light and moisture
Specification: As per USP/PhEur/IP (as applicable) or in-house specifications
Application area: Management of type 2 diabetes mellitus; glycemic control as monotherapy or in combination therapy
GMP: Y
DMF: T/P
USFDA: Y
EDQM: Y

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Product Description:

Dapagliflozin is a sodium–glucose co-transporter 2 (SGLT2) inhibitor API supplied as a white to off-white crystalline powder for use in oral antidiabetic formulations. It reduces renal glucose reabsorption, thereby increasing urinary glucose excretion. It is widely incorporated into formulations intended for glycemic management in type 2 diabetes mellitus, either as a single-agent therapy or in combination with other antidiabetic agents. It is packaged in double LDPE bags within HDPE drums, or equivalent moisture-protective pharma-grade containers, to ensure stability under recommended storage conditions.

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