Gliclazide is a second-generation sulfonylurea used for the management of type 2 diabetes mellitus. It works by stimulating insulin secretion from pancreatic beta-cells, improving glycemic control and helping maintain blood glucose levels in diabetic patients.
At Bluepill Express, we provide high-purity Gliclazide API, manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API meets IP/BP/USP/EP standards, ensuring consistent quality, stability, and therapeutic efficacy for global pharmaceutical formulations.
Therapeutic Uses
- Management of type 2 diabetes mellitus
- Effective for monotherapy or combination therapy with metformin or insulin
- Improves glycemic control and reduces fasting and postprandial blood glucose levels
- Helps in reducing the risk of diabetic complications such as retinopathy, neuropathy, and nephropathy
Mechanism of Action
Gliclazide acts by stimulating pancreatic beta-cells to release insulin in response to glucose.
Key effects include:
- Increased insulin secretion
- Reduced hepatic glucose output
- Improved peripheral glucose utilization
- Minimal effect on body weight compared to some other sulfonylureas
Pharmacological Information
| Parameter | Details |
|---|---|
| Chemical Name | 1-(hexahydrocyclopenta[c]pyrrol-2(1H)-ylcarbonyl)-3-phenylsulfonylurea |
| Molecular Formula | C15H21N3O3S |
| Molecular Weight | 323.41 g/mol |
| CAS Number | 21187-98-4 |
| Therapeutic Category | Oral Antidiabetic / Sulfonylurea |
| Pharmacopoeial Standards | IP / BP / USP / EP |
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Melting Point | 165°C – 169°C |
| Solubility | Slightly soluble in water; freely soluble in DMF, DMSO |
| Assay (on dried basis) | 98.0% – 102.0% |
| pH (1% suspension) | 5.0 – 7.0 |
Technical Specifications
| Test | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR / UV / HPLC – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Loss on Drying | ≤ 1.0% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.3% (individual), ≤ 0.5% (total) |
| Heavy Metals | ≤ 10 ppm |
| Storage | Store below 25°C, in airtight container, away from light and moisture |
Applications
- Used in oral tablet formulations for type 2 diabetes
- Suitable for generic and branded antidiabetic products
- Can be combined with metformin or other antidiabetic agents
- Ideal for long-term therapy for stable glycemic control
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH guidelines)
- Drug Master File (DMF) – available on 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 Includes: Product name, batch number, manufacturing & expiry date, net weight, storage instructions.
Shelf Life: 5 years (stored below 25°C)
Export Markets: Africa, Asia, Middle East, Latin America, CIS
