Esomeprazole Magnesium Dihydrate is a hydrated magnesium salt of esomeprazole, a proton pump inhibitor (PPI) used to reduce gastric acid secretion. It is an active pharmaceutical ingredient used in formulations for the management of acid-related gastrointestinal disorders.
Esomeprazole is the S-enantiomer of omeprazole and acts by inhibiting the gastric H⁺/K⁺-ATPase proton pump in gastric parietal cells. The dihydrate form contains two molecules of water of crystallization associated with the magnesium salt.
Esomeprazole Magnesium Dihydrate is a hydrated salt form of esomeprazole. It is used in pharmaceutical manufacturing where the specified API form requires controlled hydration and solid-state characteristics.
The commonly referenced molecular formula for Esomeprazole Magnesium Dihydrate is:
C₃₄H₃₆MgN₆O₆S₂ · 2H₂O
Molecular Weight: approximately 803.20 g/mol
CAS Number: 217087-09-7 (verify against your exact supplier specification/registration because CAS assignment can vary by specific hydrate/form representation).
Esomeprazole inhibits the H⁺/K⁺-ATPase proton pump in gastric parietal cells.
This results in:
Esomeprazole Magnesium Dihydrate is used in pharmaceutical formulations associated with:
Specific indications depend on the approved formulation and applicable regulatory labeling.
This API is a chiral proton pump inhibitor in a defined hydrated salt form. For pharmaceutical manufacturing, both the chemical quality and water/hydration state are important quality attributes.
Typical analytical evaluation may include:
Pharmaceutical-grade Esomeprazole Magnesium Dihydrate should comply with the applicable approved specification and relevant regulatory requirements.
For a hydrated API, water content and solid-state/hydrate form should be controlled according to the approved specification. Analytical techniques such as XRPD, DSC/TGA or Karl Fischer water determination may be applicable depending on the specification.
A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.
Store Esomeprazole Magnesium Dihydrate 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) | NLT 98.0% by HPLC |
| 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 | ≤ 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |