Meldonium / Mildronate

CAS number: 86426-17-7

Molecular formula: C6H14N2O2

molecular weight:

Chemical structure:

Inspection itemStandard formResult
CharacterWhite or almost white crystalline powder, very hygroscopicWhite crystalline powder
SolubilityVery soluble in water, soluble in methanol and 96% ethanol,
almost insoluble in chloroform
Complies
Indentification(1) Qualitative reaction with Dragandorf reagent
Formation of orange sediment
Complies
(2) The IR spectrum of the substance by the position of
the absorption bands should correspond to the IR spectrum
of the standard sample
Melting point85.0 – 90.0℃85.6℃
Clearness of solution
Color of solution
A 20% solution of the substance in water must be clearComplies
A 20% solution of the substance in water must be colorless
PH (10% solution)7.5 – 8,38.0
Any single impurity (HPLC)Not more than 0,1%0.04%
The total impurity (HPLC)Not more than 0,5%0.04%
ChloridesLess than 0.01%Complies
BromidesNot detectedNot detected
SulphatesLess than 0.05%Complies
Sulphated ashLess than 0.1%0.07%
Heavy metalsNot more than 0.001%Complies
WaterNot less than 19,7% but not more than 21%19.80%
Organic residuesMethanolLess than 0.3%Not detected
EthanolLess than 0.5%0.08%
Assay99.0%-101.0%99.7%
Bacterial endotoxinsNot more than 0.35 IU/mgComplies
Microbiological purityTotal plate count: ≤1000/g<30/g
Fungi: ≤100/g<20/g
Salmonella: Not detectedNot detected
E.coli: Not detectedNot detected
Staphylococcus aureus :Not detectedNot detected