Esomeprazole Magnesium Trihydrate is a hydrated magnesium salt form of esomeprazole, a proton pump inhibitor (PPI) used to reduce gastric acid secretion. It is used as an active pharmaceutical ingredient in pharmaceutical formulations for acid-related gastrointestinal disorders.
Esomeprazole is the S-enantiomer of omeprazole and works by inhibiting the gastric H⁺/K⁺-ATPase proton pump in gastric parietal cells. The trihydrate form contains three molecules of water of crystallization associated with the magnesium salt.
Esomeprazole Magnesium Trihydrate is a specific hydrated form of esomeprazole magnesium. The defined hydration state is an important characteristic of the API and should be controlled according to the manufacturer's approved specification.
Chemical Name: Esomeprazole Magnesium Trihydrate
Active Moiety: Esomeprazole
Drug Class: Proton Pump Inhibitor (PPI)
Hydration State: Trihydrate
Esomeprazole inhibits the H⁺/K⁺-ATPase proton pump located in gastric parietal cells, suppressing the final stage of gastric acid secretion.
This results in:
Esomeprazole Magnesium Trihydrate may be used in pharmaceutical formulations for:
Specific applications depend on the approved pharmaceutical formulation and regulatory labeling.
Esomeprazole Magnesium Trihydrate is a chiral pharmaceutical API in a defined hydrated magnesium-salt form. For this material, controlling the hydration state, water content and solid-state characteristics is particularly important.
Typical quality evaluation may include:
Pharmaceutical-grade Esomeprazole Magnesium Trihydrate should comply with the applicable approved specification and relevant regulatory requirements.
Depending on the specification, analytical methods such as Karl Fischer water determination, XRPD, DSC/TGA and chromatographic analysis may be used to characterize the API and its hydrated form.
A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.
Store Esomeprazole Magnesium Trihydrate in a tightly closed container, protected from excessive moisture, heat and direct light, according to the approved storage and stability requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |