Registration Dossier
Registration Dossier
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EC number: 214-230-6 | CAS number: 1115-70-4
Solubility in organic solvents / fat solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- solubility in organic solvents / fat solubility
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Principles of method if other than guideline:
- Excess Metformin hydrochloride was added to various solvents in stoppered tubes. The suspension was shaken mechanically for 90 minutes at 22 °C. It was then filtered through a 0.50-micron membrane filter for nonaqueous solvents (Millex SLSR 025 NS) or a 0.45-micron membrane filter for aqueous solvents (Millex SLHA 025 BS). The concentration of the solution was measured by ultraviolet absorption spectrophotometry at 237 nm. A dilution of each test solution was prepared in methanol so as to obtain an absorbance close to 0.5. A blank was prepared by using the dilution solvent in the same way.
A standard was prepared by dissolving 10 mg of Metformin hydrochloride in 100 mL of methanol, then diluting 1:10. - GLP compliance:
- no
- Conclusions:
- Test substance is slighthly soluble in alcohol and practically insoluble in acetone as well as methylene chloride.
- Executive summary:
European Pharmacopeia, Monograph Metformin Hydrochlorid, 2012
The reference for the solubilities is the General Notices of the European Pharmacopoeia, page 4455
Test substance is slighthly soluble in alcohol and practically insoluble in acetone as well as methylene chloride.
The meaning of the descriptive terms "slightly soluble" and "practically insoluble" is defined in the European Pharmacopeia as follows slighthly soluble: 100 -1000 ml approximate volume of solvent per gram of solute
practically insoluble: > 10000 ml approximate volume of solvent per gram of solute
Reference
Description of key information
Test substance is slighthly soluble in alcohol and practically insoluble in acetone as well as methylene chloride.
Key value for chemical safety assessment
Additional information
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