METFORMIN HYDROCHLORIDE GRANULES

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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