Pantoprazole Sodium API is the sodium salt of pantoprazole, a proton pump inhibitor (PPI) used in pharmaceutical formulations for the treatment and management of acid-related gastrointestinal disorders. The USP-monographed substance is Pantoprazole Sodium Sesquihydrate, with the molecular formula C₁₆H₁₄F₂N₃NaO₄S·1.5H₂O and molecular weight 432.37 g/mol. Its USP CAS Number is 164579-32-2.
Pantoprazole Sodium is widely used as a pharmaceutical active ingredient because of its established acid-suppressing activity and compatibility with different pharmaceutical dosage forms. It is used in the manufacture of oral and parenteral products and is particularly associated with delayed-release formulations designed to protect the active ingredient from degradation in acidic gastric conditions.
USP specifically defines Pantoprazole Sodium as containing 98.0% to 102.0% of pantoprazole sodium calculated on the anhydrous basis.
Pantoprazole Sodium requires careful control of its hydrated state because the USP assay is calculated on the anhydrous basis, while water is separately controlled. USP identifies the pharmaceutical substance as a sesquihydrate and provides a defined analytical framework for assay and related substances.
Typical USP-related quality parameters include:
Pantoprazole Sodium Sesquihydrate is generally supplied as a white to off-white crystalline powder. Commercial analytical documentation describes the material as a powder and confirms identity through FTIR, HPLC retention time and sodium identification.
The material is freely soluble in water and has limited solubility in several organic solvents. Its physical behavior is important during pharmaceutical processing, formulation development, packaging and storage.
Quality testing for Pantoprazole Sodium API can include:
The USP monograph lists reference standards for Pantoprazole Related Compounds A, B, C, E and D/F mixture, demonstrating the importance of chromatographic impurity control for this API.
Pantoprazole Sodium API manufacturing requires appropriate control of raw materials, reaction conditions, purification, crystallization and the final hydration state. The sesquihydrate form should be maintained consistently because its water content directly affects calculations performed on an anhydrous basis.
For pharmaceutical manufacturing, API quality documentation should include analytical specifications, certificate of analysis, impurity profile, residual-solvent information, water content, packaging information and applicable pharmacopoeial compliance.
USP historical monograph information specifies preservation in well-closed, light-resistant containers and storage at room temperature.
Pantoprazole Sodium Bulk API is used by pharmaceutical manufacturers for the production of finished dosage forms. Bulk API procurement should clearly identify the hydrate form, CAS number, assay basis, water-content specification and applicable pharmacopoeial standard.
The USP form should be distinguished from anhydrous Pantoprazole Sodium. USP lists 164579-32-2 for the sesquihydrate and 138786-67-1 for the anhydrous substance.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.20% |
| Total Impurities | NMT 0.50% |
| Water Content | 5.0–8.0% |