Metformin Hydrochloride Powder

Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of metformin hydrochloride powder in China. Welcome to wholesale bulk high quality metformin hydrochloride powder for sale here from our factory. Good service and reasonable price are available.

Metformin Hydrochloride Powder is a white crystalline powder belonging to the biguanide class of oral antihyperglycemic agents, widely used in the management of type 2 diabetes mellitus. It exhibits high solubility in water (50 mg/mL at 20 °C), is slightly soluble in ethanol, and is practically insoluble in acetone and dichloromethane. Chemically, it is 1,1‑dimethylbiguanide hydrochloride, with a molecular formula of C₄H₁₂ClN₅ and a molecular weight of 165.62. Its primary mechanism of action centers on improving insulin sensitivity and reducing hyperglycemia through multiple pathways: it suppresses hepatic gluconeogenesis and glycogenolysis, thereby decreasing endogenous glucose production, and enhances insulin‑mediated glucose uptake and utilization in peripheral tissues, particularly skeletal muscle. Unlike sulfonylurea drugs, metformin does not stimulate direct insulin secretion from pancreatic β‑cells, which contributes to its relatively low risk of hypoglycemia as a monotherapy. In addition to its glucose‑lowering effects, metformin activates AMP‑activated protein kinase (AMPK), a key cellular energy sensor, which in turn inhibits the expression of adipogenic enzymes, promotes fatty acid oxidation, and exerts favorable effects on lipid profiles and body weight regulation. These pleiotropic actions make metformin not only a cornerstone in glycemic control but also a valuable agent in the comprehensive management of metabolic risk factors associated with type 2 diabetes.

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Metformin Hydrochloride Powder

Metformin Hydrochloride Pill

Additional information of chemical compound:

Metformin Hydrochloride COA

Certificate of Analysis
Compound name	Metformin hydrochloride
Grade	Pharmaceutical grade
CAS No.	1115-70-4
Quantity	30g
Packaging standard	PE bag+Al foil bag
Manufacturer	Shaanxi BLOOM TECH Co., Ltd
Lot No.	202501090041
MFG	Jan 9th 2025
EXP	Jan 8th 2028
Structure
Item	Enterprise standard	Analysis result
Appearance	White or almost white powder	Conformed
Water content	≤5.0%	0.39%
Loss on drying	≤1.0%	0.28%
Heavy Metals	Pb≤0.5ppm	N.D.
	As≤0.5ppm	N.D.
	Hg≤0.5ppm	N.D.
	Cd≤0.5ppm	N.D.
Purity (HPLC)	≥99.0%	99.90%
Single impurity	<0.8%	0.47%
Total microbial count	≤750cfu/g	80
E. Coli	≤2MPN/g	N.D.
Salmonella	N.D.	N.D.
Ethanol (by GC)	≤5000ppm	500ppm
Storage	Store in a sealed, dark, and dry place below 2-8°C

Metformin Hydrochloride Powder, as the most widely used oral hypoglycemic drug globally, has a direct impact on drug quality, bioavailability, and clinical efficacy due to the stability of its solid form. The diversity of solid forms, such as polymorphs and hydrates, may lead to significant differences in drug solubility, dissolution rate, and physicochemical properties, which in turn affect formulation processes and storage conditions.

Physical and Chemical Properties and Solid Form Basis of Metformin Hydrochloride

Basic Physical and Chemical Parameters

The molecular formula of metformin hydrochloride is C ₄ H ₁₂ ClN ₅, with a molecular weight of 165.62 and a CAS number of 1115-70-4. Its solid form is a white crystalline powder, with a melting point of 223-226 ° C, a boiling point of 224.1 ° C (760 mmHg), and a vapor pressure of 0.0929 mmHg at 25 ° C. In terms of solubility, the compound is easily soluble in water (50 mg/mL), slightly soluble in ethanol, and almost insoluble in acetone and dichloromethane. The pharmacopoeia standard specifies that pharmaceutical grade raw materials must be white or off white crystalline powders with a content of not less than 99%, a moisture content of less than 0.5%, and no obvious impurities or unpleasant odors.

 

 

The influence of solid form on drug performance

The solid form (crystal form, hydrate, amorphous) directly affects the solubility, dissolution rate, bioavailability, and stability of drugs. For example, drugs with different crystal forms may have different solubility due to differences in lattice energy, which in turn affects dissolution behavior and clinical efficacy. The formation of hydrates may alter the hygroscopicity, flowability, and compressibility of drugs, placing higher demands on the formulation process. Therefore, screening and controlling the polymorphic and hydrate states of metformin hydrochloride is a key step in ensuring drug quality consistency.

Definition and classification of polymorphs
Polycrystalline form refers to multiple crystal structures formed by the same compound in different molecular arrangements. According to the differences in intermolecular forces, polymorphs can be classified into inclusion complexes, eutectics, solvates (including hydrates), and other types. For metformin hydrochloride, the polymorphic phenomenon may lead to significant differences in its physicochemical properties (such as solubility, melting point) and biological activity (such as pharmacokinetic parameters).

Research progress on polymorphic forms of metformin hydrochloride
Existing studies have reported multiple crystal forms of metformin hydrochloride, among which the X-ray powder diffraction pattern of metformin dihydrochloride (a new crystal form) shows characteristic diffraction peaks at specific 2 θ values (such as 12.2 °± 0.2 °, 13.1 °± 0.2 °). The discovery of this crystal form provides new possibilities for drug development, such as optimizing drug solubility and dissolution rate through crystal form regulation.

Polycrystalline screening technology
X-ray diffraction (XRD)
XRD is the "gold standard" for polymorphic screening. By analyzing the diffraction pattern of crystals on X-rays, the cell parameters and molecular arrangement can be determined. For example, in the XRD pattern of metformin hydrochloride, the diffraction peaks at 12.2 ° and 13.1 ° are its characteristic identifiers, which can be used to quickly distinguish this crystal form from other forms.

Raman Spectroscopy
Raman spectroscopy provides structural information by detecting molecular vibration modes, and has advantages such as non-destructive, high sensitivity, and no need for sample preparation.

Research has shown that the Raman spectrum of metformin hydrochloride exhibits narrow spectral lines (4-10 cm ⁻¹) in the range of 70-1600 cm ⁻¹, corresponding to specific chemical bond vibrations (such as N-H stretching vibration, C-N bending vibration). These "fingerprint" features can be used to identify crystal types and crystal states without damaging the sample.

Fourier Transform Infrared Spectroscopy (FTIR)
FTIR analyzes chemical bonds and functional groups by detecting the absorption characteristics of molecules towards infrared light. The FTIR spectrum of metformin hydrochloride shows that the strong peak at 3368.23 cm ⁻¹ corresponds to N-H stretching vibration, and the peak at 1621.05 cm ⁻¹ corresponds to N-H bending vibration. The FTIR spectra of different crystal forms may exhibit subtle differences due to differences in intermolecular forces, and require comprehensive analysis in conjunction with other techniques.

Thermal analysis techniques (DSC/TGA)
Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) can detect the temperature of crystal transformation and thermal stability. For example, DSC can measure differences in melting points, while TGA can analyze changes in moisture content, providing supplementary information for crystal screening.

Formation mechanism and screening strategy of hydrates

Formation mechanism of metformin hydrochloride hydrate

The amino (- NH ₂) and imino (- NH -) groups in Metformin Hydrochloride Powder molecules can serve as hydrogen bond donors, forming a stable hydrogen bond network with water molecules. In humid environments, drug molecules may capture water molecules through hydrogen bonding to form hydrates. For example, improper storage conditions may lead to the conversion of anhydrous substances into hydrates, thereby affecting the quality of the drug.

Definition and classification of hydrates

Hydrate refers to the crystal structure formed by the combination of drug molecules and water molecules through hydrogen bonding or other forces. According to the ratio of water molecules to drug molecules, hydrates can be divided into monohydrate, dihydrate, etc. The formation of hydrates may significantly alter the physicochemical properties of drugs, such as hygroscopicity, solubility, and stability.

Hydrate screening technology

Combination of XRD and Raman Spectroscopy

XRD can detect the characteristic diffraction peaks of hydrates, while Raman spectroscopy can confirm the hydrate state by analyzing the vibration modes of water molecules (such as O-H stretching vibration). For example, the Raman spectrum of hydrates may exhibit broad peaks in the range of 3200-3600 cm ⁻¹, corresponding to O-H stretching vibrations.

Stability of Solid Form and Pharmacopoeia Standards

Pharmacopoeia Requirements for Solid Form

The pharmacopoeia clearly requires that pharmaceutical grade metformin hydrochloride should be a white or off white crystalline powder with no obvious impurities or unpleasant odor. This requirement implies control over crystal consistency, as the presence of impurities or different crystal forms may lead to abnormal appearance. In addition, the pharmacopoeia strictly limits the content (≥ 99%) and moisture (≤ 0.5%), indirectly ensuring the stability of solid form.

 

Metformin Hydrochloride Powder

 

It should be stored in a cool, dry place to avoid contact with strong oxidants. High temperature or high humidity environments may induce crystal transformation or hydrate formation, such as: Temperature effect: High temperatures may disrupt hydrogen bonding networks, leading to crystal transformation or amorphization.
Humidity impact: High humidity environments may promote the adsorption of water molecules, form hydrates, or cause moisture absorption and agglomeration.

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