Esomeprazole Magnesium Amorphous is an amorphous form of esomeprazole magnesium, a proton pump inhibitor (PPI) used as an active pharmaceutical ingredient in medicines for acid-related gastrointestinal disorders. It suppresses gastric acid secretion by inhibiting the H⁺/K⁺-ATPase proton pump in gastric parietal cells.
The amorphous form is characterized by a non-crystalline solid-state structure, which distinguishes it from crystalline forms of esomeprazole magnesium. Control of solid-state form and physical characteristics is important during pharmaceutical manufacturing and quality evaluation.
Esomeprazole Magnesium Amorphous is the magnesium salt of the S-enantiomer of omeprazole, present in an amorphous solid form.
It belongs to the proton pump inhibitor class and is used in pharmaceutical formulations designed to reduce gastric acid production.
CAS Number: 217087-09-7 (for esomeprazole magnesium; confirm the exact CAS/form against your approved specification)
Esomeprazole inhibits the gastric H⁺/K⁺-ATPase proton pump in parietal cells, thereby suppressing the final step of gastric acid secretion.
This results in:
Esomeprazole Magnesium Amorphous is used as an API for pharmaceutical formulations associated with:
Specific indications depend on the approved pharmaceutical formulation and applicable regulatory labeling.
Esomeprazole Magnesium Amorphous is a chiral pharmaceutical API with a controlled amorphous solid-state form. In addition to conventional chemical quality attributes, characterization of the solid-state form is particularly relevant.
Typical analytical evaluation may include:
Pharmaceutical-grade Esomeprazole Magnesium Amorphous should comply with the applicable approved specification and relevant regulatory requirements.
For an amorphous API, solid-state characterization is an important quality consideration. Depending on the approved specification, techniques such as XRPD, DSC or related solid-state analytical methods may be used to characterize the material.
A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.
Store Esomeprazole Magnesium Amorphous in a tightly closed container, protected from moisture, heat and direct light, according to the manufacturer's approved storage and stability requirements.
| Parameter | Specification |
|---|---|
| Appearance | 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 | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |