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Glimepiride is a potent third-generation sulfonylurea derivative widely used for the management of Type 2 Diabetes Mellitus (T2DM). It effectively lowers blood glucose by stimulating insulin secretion from pancreatic β-cells and improving insulin sensitivity in peripheral tissues.
At Bluepill Express, we manufacture and export high-purity Glimepiride API that meets IP, BP, USP, and EP pharmacopoeial standards. Our Glimepiride is recognized globally for its superior assay value, low impurity profile, and excellent stability, making it ideal for tablet and capsule formulations.
Therapeutic Uses
- Management of Type 2 Diabetes Mellitus (T2DM)
- Used as monotherapy or in combination with other antidiabetic agents (e.g., metformin, pioglitazone)
- Helps in reducing fasting and postprandial blood glucose levels
- Improves glycemic control in patients resistant to dietary therapy and exercise alone
Mechanism of Action
Glimepiride binds to the sulfonylurea receptor (SUR1) on pancreatic β-cells, leading to the closure of ATP-sensitive potassium channels. This action results in:
- Membrane depolarization
- Opening of calcium channels
- Increased intracellular calcium
- Enhanced insulin secretion
Additionally, Glimepiride increases peripheral glucose uptake and reduces hepatic glucose production, ensuring overall glycemic control.
Pharmacological Information
- Chemical Name: 3-Ethyl-4-methyl-N-[2-[4-[(N-(1-phenylethyl)carbamoyl)sulfamoyl]phenyl]ethyl]-2-oxo-2H-pyrrole-1-carboxamide
- Molecular Formula: C24H34N4O5S
- Molecular Weight: 490.62 g/mol
- CAS Number: 93479-97-1
- Therapeutic Category: Antidiabetic / Sulfonylurea Derivative
- Pharmacopoeial Standards: IP / BP / USP / EP
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Taste | Tasteless |
| Melting Point | 207°C – 210°C |
| Solubility | Practically insoluble in water; soluble in dimethylformamide and slightly soluble in methanol |
| pH (1% suspension) | 5.5 – 7.5 |
| Assay (on dried basis) | 98.0% – 102.0% |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR / HPLC – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.3% (individual), ≤ 0.5% (total) |
| Heavy Metals | ≤ 10 ppm |
| Storage Conditions | Store in a cool, dry, dark place, below 25°C |
Applications
- Used in oral antidiabetic formulations (tablets and capsules)
- Commonly combined with Metformin, Pioglitazone, or Sitagliptin
- Suitable for generic and branded formulations in domestic and export markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH-compliant)
- Drug Master File (DMF) – available upon request
Packaging & Export Details
| Packaging Type | Net Weight |
|---|---|
| HDPE Drum | 25 kg |
| Fiber Drum | 25 kg |
| LDPE Inner Bag | 1 kg / 5 kg / 10 kg |
- Labeling: Product name, Batch no., MFG/EXP date, Net weight, Storage instructions
- Shelf Life: 5 years (when stored below 25°C)
- Export Markets: Africa, Latin America, CIS, Middle East, Asia
