Pantoprazole Sodium Sesquihydrate API is the sesquihydrate form of pantoprazole sodium and belongs to the proton pump inhibitor (PPI) class of pharmaceutical active ingredients. It is used in pharmaceutical formulations designed to reduce gastric acid secretion and is widely associated with medicines for acid-related gastrointestinal disorders.
Pantoprazole Sodium Sesquihydrate has the molecular formula C16H14F2N3NaO4S·1.5H2O and a molecular weight of 432.37 g/mol. The CAS Number is 164579-32-2. The corresponding anhydrous pantoprazole sodium has a different molecular weight and CAS number, so the hydrate form should be clearly specified in API documentation.
Pantoprazole Sodium Sesquihydrate API is used in the manufacture of pharmaceutical products intended for acid suppression. It is incorporated into oral and parenteral formulations depending on the formulation design and applicable regulatory requirements.
Typical applications include:
Pantoprazole Sodium Sesquihydrate requires controlled analytical testing because the API exists as a defined hydrate. The amount of water associated with the crystal structure is important when calculating assay on an anhydrous basis.
The USP monograph specifies an assay of 98.0–102.0%, calculated on the anhydrous basis. Water content is separately controlled at 5.0–8.0% in the cited USP specification.
Important quality parameters include:
Pantoprazole Sodium Sesquihydrate has a defined related-substances profile under the USP framework. The specified impurity controls include Pantoprazole Related Compounds A, B, C, D, E and F.
The cited USP limits include:
These values should be used only with the applicable pharmacopoeial method and current controlled specification.
Pantoprazole Sodium Sesquihydrate is supplied as a white to off-white crystalline material. It is freely soluble in water and has limited solubility in several organic solvents.
The sesquihydrate form is particularly important for pharmaceutical manufacturing because its molecular weight and water content differ from the corresponding anhydrous sodium salt.
The material should therefore be identified in purchase specifications, certificates of analysis and regulatory documentation as Pantoprazole Sodium Sesquihydrate, rather than simply using the generic term Pantoprazole Sodium.
Pantoprazole Sodium Sesquihydrate API manufacturing requires controlled synthesis, purification, crystallization and hydration-state management. Control of water content is particularly important because the material is supplied as a sesquihydrate and the assay is calculated on an anhydrous basis.
Quality-control testing can include:
Pantoprazole Sodium Sesquihydrate Bulk API is used by pharmaceutical manufacturers for the development and manufacture of pantoprazole-containing formulations. For bulk API procurement, the exact hydrate state, CAS Number, molecular weight, assay basis, water content and impurity limits should be specified.
The distinction between Pantoprazole Sodium Sesquihydrate and anhydrous Pantoprazole Sodium is important:
Using the correct hydrate-specific information helps maintain consistency between purchasing specifications, CoA documentation, analytical calculations and regulatory submissions.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.20% |
| Total Impurities | NMT 0.50% |
| Water Content | 5.0–8.0% |