Omeprazole Sodium is an important pharmaceutical active ingredient belonging to the proton pump inhibitor (PPI) class. It is the sodium salt form of omeprazole and is widely associated with medicines used for controlling excessive gastric acid secretion. Omeprazole Sodium acts on the gastric proton pump, the H+/K+-ATPase, which is responsible for the final stage of gastric acid secretion in the stomach. By inhibiting this enzyme system, omeprazole reduces gastric acid production and provides an important pharmacological approach for acid-related gastrointestinal disorders.
Omeprazole Sodium API is identified by CAS Number 95510-70-6. FDA's Global Substance Registration System identifies the substance with the UNII KV03YZ6QLW. The molecular formula of the anhydrous sodium salt is C17H18N3NaO3S, with a molecular weight of 367.4 g/mol. However, the current BP/Ph. Eur. monograph describes the pharmaceutical substance as Omeprazole Sodium monohydrate, with the formula C17H18N3NaO3S·H2O and molecular mass 385.4 g/mol.
Omeprazole Sodium is a benzimidazole-derived proton pump inhibitor. Chemically, it is described as sodium 5-methoxy-2-[(RS)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole monohydrate in the Ph. Eur./BP monograph. The sodium salt provides a distinctly different material profile from neutral Omeprazole and should therefore be identified separately in pharmaceutical procurement and technical documentation.
The BP 2025/Ph. Eur. monograph describes Omeprazole Sodium as a white or almost white, hygroscopic powder. It is reported as freely soluble in water and ethanol (96%), soluble in propylene glycol and very slightly soluble in methylene chloride. These physical characteristics are particularly relevant when evaluating the pharmaceutical material and distinguishing it from the neutral Omeprazole API.
The compound has one stereogenic sulfur center and is represented as a racemic material in the FDA substance record. FDA records the optical activity as (+/−) and identifies the substance as Omeprazole Sodium.
Omeprazole Sodium is a proton pump inhibitor that suppresses gastric acid secretion. In the acidic environment of gastric parietal cells, omeprazole is converted to an active sulfenamide species that interacts with the gastric H+/K+-ATPase. This inhibits the final step in gastric acid secretion into the gastric lumen.
Because of this mechanism, Omeprazole and its sodium salt have pharmaceutical relevance in the management of acid-related gastrointestinal conditions. Pharmacopoeial references describe Omeprazole Sodium as a proton pump inhibitor used in connection with the treatment of peptic ulcer disease.
The sodium form also has particular importance in pharmaceutical formulations where the physicochemical properties of the sodium salt are advantageous. Omeprazole Sodium is used in pharmaceutical preparations including parenteral formulations, and BP specifically lists Omeprazole for Injection as a preparation associated with the substance.
Quality control is a critical consideration when selecting an Omeprazole Sodium Pharmaceutical API. The BP/Ph. Eur. monograph provides defined requirements for identification, assay, water content, pH and related substances.
The monograph specifies a content of 98.0% to 101.0% calculated on the anhydrous substance. This is an important distinction because Omeprazole Sodium is described pharmacopoeially as a monohydrate. The assay therefore should not be incorrectly presented as a simple percentage of the hydrated material without reference to the calculation basis.
Water is also a specifically controlled characteristic. The BP/Ph. Eur. monograph specifies 4.5% to 10.0% water, determined on 0.300 g of substance. This range reflects the monohydrate nature and hygroscopic characteristics of the pharmaceutical material.
The Ph. Eur./BP monograph provides defined chromatographic controls for related substances. Omeprazole impurities D and E are each limited to NMT 0.15%, unspecified impurities are limited to NMT 0.10% each, and total impurities are limited to NMT 0.50%. A 0.05% reporting/disregard threshold is also specified.
The monograph identifies impurity D as omeprazole sulfone and impurity E as a corresponding pyridine N-oxide-related substance. Other detectable impurities identified in the monograph include compounds designated A, B and C. These controls are important for demonstrating the chemical quality and purity of Omeprazole Sodium API.
The BP/Ph. Eur. monograph specifies a pH range of 10.3 to 11.3 for Solution S. Solution S is prepared by dissolving 0.50 g of the substance in carbon-dioxide-free water and diluting to 25 mL. The solution must also be clear and not more intensely coloured than the specified reference solution.
Identification is established through multiple approaches. The monograph includes optical rotation, infrared absorption spectrophotometry, and a sodium identification reaction. The specified optical rotation range is −0.10° to +0.10°, determined on Solution S.
Omeprazole Sodium Bulk API is relevant to pharmaceutical manufacturing, formulation development and organizations involved in producing medicines containing Omeprazole Sodium. When evaluating bulk material, the exact form of the substance should be confirmed because Omeprazole Sodium monohydrate has different molecular mass and water-content characteristics from anhydrous Omeprazole Sodium.
The pharmacopoeial material is hygroscopic and therefore appropriate packaging and protection from environmental exposure are important. BP specifies storage in an airtight container and protected from light.
For pharmaceutical applications, a bulk API technical package can include the product specification, batch-specific Certificate of Analysis, identity data, assay, water content, related-substance profile, residual-solvent information where applicable and relevant regulatory documentation.
India has a large pharmaceutical manufacturing ecosystem and is an important market for pharmaceutical API development and production. Organizations researching an Omeprazole Sodium API Manufacturer India may evaluate sources based on quality systems, manufacturing capabilities, analytical facilities, batch consistency and regulatory documentation.
When selecting an Omeprazole Sodium Manufacturer India, technical identification should clearly state whether the material is the pharmacopoeial monohydrate. This is especially important because databases may report the anhydrous molecular weight of 367.4 g/mol, while the BP/Ph. Eur. monograph lists the monohydrate at 385.4 g/mol.
A comprehensive technical package for Omeprazole Sodium API can include:
The BP/Ph. Eur. monograph provides particularly useful numerical information for Omeprazole Sodium API. The pharmaceutical substance contains 98.0%–101.0% of Omeprazole Sodium calculated on the anhydrous substance. Its water content is controlled at 4.5%–10.0%, while Solution S must have a pH of 10.3–11.3. Related impurities D and E are each limited to 0.15%, unspecified impurities to 0.10% each, and total impurities to 0.50%.
These values make Omeprazole Sodium a good example of why API specifications should be taken from the correct salt form and pharmacopoeial monograph rather than copied from the specification of neutral Omeprazole.
Omeprazole Sodium is a well-established pharmaceutical API and proton pump inhibitor with clearly defined chemical and pharmacopoeial characteristics. The substance is identified by CAS 95510-70-6, while the BP/Ph. Eur. monograph describes the pharmaceutical material as a monohydrate with molecular mass 385.4 g/mol.
For organizations searching for Omeprazole Sodium API Manufacturer in India, Omeprazole Sodium API Supplier India, Omeprazole Sodium Pharmaceutical API, Omeprazole Sodium Bulk API or Omeprazole Sodium Manufacturer India, product identity, pharmacopoeial compliance, assay, water content, impurity control and documentation should be carefully evaluated.
The availability of defined BP/Ph. Eur. numerical requirements provides a strong technical basis for evaluating Omeprazole Sodium API. Using the correct monohydrate form, CAS Number 95510-70-6, assay basis and water range is essential for maintaining an accurate pharmaceutical product database and avoiding confusion between Omeprazole Sodium and neutral Omeprazole.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| pH (1% Solution) | 10.3 – 11.3 |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |
| Water Content | 4.5% – 10.0% |
| Specific Rotation | −0.10° to +0.10° |