Metformin Hydrochloride Granules are an oral antidiabetic intermediate formulation used in the production of Metformin tablets and capsules. This granulated form of Metformin offers excellent flowability, compressibility, and uniform particle size, ensuring enhanced tablet uniformity and consistent drug release.
At Bluepill Express, we produce pharmaceutical-grade Metformin Hydrochloride Granules under WHO-GMP and ISO 9001:2015-certified facilities, strictly adhering to IP, BP, USP, and EP standards.
These granules are designed for direct compression (DC) or wet granulation manufacturing, supporting cost-effective, high-yield pharmaceutical production.
Therapeutic Category
- Biguanide Antidiabetic Agent
- Oral Hypoglycemic API
Mechanism of Action
Metformin Hydrochloride reduces hepatic glucose production, enhances insulin sensitivity, and improves peripheral glucose uptake.
It works by activating AMP-activated protein kinase (AMPK), which helps regulate glucose metabolism without increasing insulin secretion—making it one of the most effective first-line therapies for Type 2 Diabetes Mellitus.
Chemical Information
| Parameter | Details |
|---|---|
| Chemical Name | 1,1-Dimethylbiguanide Hydrochloride |
| Molecular Formula | C4H11N5·HCl |
| Molecular Weight | 165.63 g/mol |
| CAS Number | 1115-70-4 |
| Pharmacopoeial Standards | IP / BP / USP / EP |
| Therapeutic Class | Oral Antidiabetic / Hypoglycemic Agent |
Physical & Chemical Properties
| Property | Specification |
|---|---|
| Appearance | White to off-white free-flowing granules |
| Odor | Odorless |
| Taste | Bitter |
| Solubility | Freely soluble in water, practically insoluble in acetone and methylene chloride |
| pH (1% w/v solution) | 6.5 – 7.5 |
| Melting Point | 220°C – 226°C (decomposition) |
| Stability | Stable under normal temperature and humidity |
| Storage | Store below 25°C, in a cool, dry, and well-ventilated area |
Technical Specifications (Bluepill Express Standard)
| Parameter | Specification |
|---|---|
| Identification | Positive (IR & UV match reference) |
| Assay (Purity) | ≥ 98.5% to ≤ 101.0% (on dry basis) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.2% (individual impurity) |
| Heavy Metals | ≤ 10 ppm |
| Granule Size | Uniform; 30–80 mesh range |
| Bulk Density | 0.4 – 0.6 g/ml |
| Tapped Density | 0.7 – 0.9 g/ml |
| Flow Property | Excellent (for tablet compression) |
| Moisture Content | ≤ 0.5% |
Pharmacological Applications
- Type 2 Diabetes Mellitus (T2DM) – First-line therapy for glucose control
- Metabolic Syndrome – Reduces insulin resistance and improves lipid profiles
- Polycystic Ovary Syndrome (PCOS) – Enhances ovulation and reduces insulin resistance
- Weight Management (Adjunct) – Supports metabolic regulation and glycemic balance
Packaging & Export Details
| Detail | Specification |
|---|---|
| Available Packs | 5 kg / 10 kg / 25 kg HDPE drums with double liner |
| Shelf Life | 36 months (under controlled storage) |
| Labeling | Export-compliant, includes batch no., manufacturing & expiry date |
| Export Markets | Asia, Africa, Middle East, Latin America, CIS, and Europe |
| Supply Form | Granulated ready-to-compress powder |
Documentation Supplied
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (as per ICH Q1A guidelines)
- Non-GMO, Allergen-Free, and Residual Solvent Declarations
- DMF / CTD dossier support available on request