Metformin hydrochloride

CAS Number
1115-70-4
EC Number
214-230-6

What is Metformin hydrochloride?

Metformin hydrochloride (CAS 1115-70-4) is the active pharmaceutical ingredient form of metformin, its stable salt for pharmaceutical manufacturing. Also known as N,N-Dimethylbiguanide hydrochloride.

Where is Metformin hydrochloride used?

  • Pharmaceutical manufacturing: API in immediate-release and extended-release oral solid dosage forms, including tablets and film-coated tablets made to pharmacopeial specifications
  • Fixed-dose combination products with other antidiabetic agents
  • Contract manufacturers and generic drug producers: bulk quantities for high-throughput tableting lines
  • Research institutions and formulation development labs: smaller quantities for bioequivalence studies and novel delivery system development
  • It is one of the highest-volume oral antidiabetic APIs in global pharmaceutical production.

Good to know: Grade selection is typically driven by the target market's regulatory requirements. Consistent particle size and compressibility are critical procurement criteria.

Commercial specifications

  • Packaging from multi-kilogram drums to metric-ton quantities

Other Names (Synonyms)

N1,N1-Dimethylbiguanide|N,N-Dimethylbiguanide hydrochloride|Metiguanide monohydrochloride|Metformin monohydrochloride|Metformin HCl|Glucophage (TN)|Dimethylbiguanide hydrochloride|1,1-Dimethylbiguanide monohydrochloride

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What are the physical properties of Metformin hydrochloride?

Melting Point 232 °C
Density 1.351 g/cm³ (solid)
Flash Point 9°C
Appearance Crystalline Solid
Color White
Form Powder
Water Solubility Soluble in water (50 mg/ml), ethanol, and DMSO (50 mM).
Vapor Pressure 0.001Pa at 25℃
Log P -3.5 at 20℃

How is Metformin hydrochloride classified and handled safely? Learn More

Warning
GHS07· Irritant

Hazard Statements

H302 Harmful if swallowed
H315 Causes skin irritation
H319 Causes serious eye irritation
H335 May cause respiratory irritation
H412 Harmful to aquatic life with long lasting effects

Precautionary Statements

P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P264 Wash … thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P271 Use only outdoors or in a well-ventilated area.

Which trade and regulatory codes apply to Metformin hydrochloride?

HS Code 29252900
UN Number 1230
Packing Group II
Storage Class 11 - Combustible Solids
WGK (Germany) 3
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