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DAPAGLIFLOZIN IP/BP/EP/USP

Name: DAPAGLIFLOZIN IP/BP/EP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

Get a Price/Quote

MOQ : 25 Kilograms

DAPAGLIFLOZIN IP/BP/EP/USP Specification

Residue on Ignition
0.1%

Assay
>=99%

Molecular Weight
408.88 g/mol

Heavy Metal (%)
0.001%

Place of Origin
India

Storage
Store in a cool, dry place, protected from light.

Loss on Drying
0.5%

HS Code
29420090

Molecular Formula
C21H25ClO6

Particle Size
D90 10 micron

Moisture (%)
0.5%

Melting Point
124C130C

Other Names
Dapagliflozin Propanediol Monohydrate

CAS No
461432-26-8

Type
Pharmaceutical Raw Materials

Grade
Pharmaceutical Grade

Usage
Antidiabetic agent, SGLT2 inhibitor

Purity
>=99%

Appearance
Solid

Application
Used for formulation of antidiabetic drugs

Raw Material
API for pharmaceutical manufacturing

Smell
Odorless

Color
White to off-white

Form
Powder

Packing
As per customer requirement (typically 1kg/5kg/10kg drum)

Solubility
Slightly soluble in water, soluble in ethanol and DMSO

Impurities
Total impurities 0.2%

Identification
Meets requirements as per pharmacopeia

Shelf Life
2 years when properly stored

About DAPAGLIFLOZIN IP/BP/EP/USP

Dapagliflozin is an oral medication prescribed primarily for the management of type 2 diabetes mellitus. It belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, which function by inhibiting SGLT2 in the proximal renal tubules of the kidneys. This action reduces the reabsorption of glucose from the urine back into the bloodstream, thereby increasing urinary glucose excretion and lowering blood glucose levels.

Consistent Quality and Compliance

Manufactured to rigorous pharmacopeial specifications, dapagliflozin API stands out for its high purity and consistent particle size. Each batch meets identification standards required by IP/BP/EP/USP and is thoroughly tested to ensure impurity levels are well below acceptable limits, ensuring efficacy and safety in finished formulations.

Versatility in Pharmaceutical Formulation

Dapagliflozin's solubility in ethanol and DMSO, combined with its stability and moderate particle size (D90 10 micron), facilitates its use in various dosage forms. Its application as an SGLT2 inhibitor makes it an essential component in modern antidiabetic therapies, aiding pharmaceutical developers in creating effective medications for metabolic health.

FAQ's of DAPAGLIFLOZIN IP/BP/EP/USP:

Q: How should dapagliflozin API be stored for optimal shelf life?

A: Dapagliflozin should be stored in a cool, dry place and protected from light. Proper storage conditions will help maintain its potency and ensure a shelf life of two years.

Q: What is the recommended usage of dapagliflozin API in pharmaceutical manufacturing?

A: Dapagliflozin is primarily used as an active pharmaceutical ingredient (API) for formulating antidiabetic drugs, particularly those targeting SGLT2 inhibition in type 2 diabetes management.

Q: When should the identification and purity of dapagliflozin API be tested?

A: Testing for identification, purity, and compliance with pharmacopeial requirements should be performed upon receipt and before formulation to ensure product quality and safety.

Q: Where is dapagliflozin API manufactured and supplied from?

A: This product is manufactured, supplied, and traded from India by established pharmaceutical raw material providers who adhere to global quality standards.

Q: What benefits does using pharmaceutical grade dapagliflozin offer to drug manufacturers?

A: Drug manufacturers benefit from dapagliflozin's excellent purity (99%), consistent quality, low impurity levels, and compliance with international pharmacopeial standards, ensuring reliable formulation of antidiabetic medications.

Q: What packing options are available for dapagliflozin API?

A: Packing can be tailored to customer requirements, most commonly available in drums of 1 kg, 5 kg, or 10 kg for flexible handling and storage.

Q: How is the process of using dapagliflozin in formulations ensured to be safe?

A: Pharmaceutical manufacturers follow strict quality control protocols, including impurity profiling, particle size analysis, and compliance with pharmacopeial specifications, to guarantee safe and effective drug formulations.

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