Salcaprozate Sodium, commonly known as SNAC, is a pharmaceutical-grade oral absorption enhancer and intestinal permeation-promoting excipient. Chemically, it is the sodium salt of salcaprozic acid and is also known as sodium 8-[(2-hydroxybenzoyl)amino]octanoate. Salcaprozate Sodium has attracted significant pharmaceutical interest because of its ability to enhance the oral absorption of molecules that would otherwise have limited gastrointestinal bioavailability. The FDA Substance Registration System identifies Salcaprozate Sodium under UNII 1YTW0422YU and CAS Number 203787-91-1.
Salcaprozate Sodium has the molecular formula C₁₅H₂₀NNaO₄ and molecular weight 301.31 g/mol. PubChem identifies it as the sodium salt form of salcaprozate and gives the systematic chemical name sodium 8-[(2-hydroxybenzoyl)amino]octanoate.
SNAC is particularly relevant to oral delivery technologies involving peptides and other macromolecules with poor membrane permeability. It functions as a chemical permeation enhancer and can facilitate intestinal transport by interacting with the intestinal environment and increasing the effective absorption of selected active substances. Research literature describes SNAC as an intestinal permeation enhancer for oral delivery of macromolecules.
Salcaprozate Sodium is an achiral small molecule derived from salcaprozic acid. It contains a salicylamide-type structure linked to an eight-carbon chain terminating in a sodium carboxylate. The sodium salt provides the ionic form used in pharmaceutical formulations.
For pharmaceutical manufacturing, correct identification of SNAC is important because Salcaprozate Sodium should not be confused with salcaprozic acid, which has a different molecular formula and molecular weight. The sodium salt is specifically identified by CAS 203787-91-1, formula C₁₅H₂₀NNaO₄, and molecular weight approximately 301.31 g/mol.
The most prominent pharmaceutical application of Salcaprozate Sodium is as an oral absorption enhancer. FDA's review of oral semaglutide identifies SNAC as an excipient in the tablet formulation, with 300 mg SNAC per tablet in the 3 mg, 7 mg and 14 mg semaglutide strengths reviewed in the application.
SNAC has also been investigated as an absorption-promoting technology for other poorly absorbed compounds, including peptides and proteins such as insulin and heparin. Its role is therefore particularly relevant to pharmaceutical companies developing oral delivery platforms for biologics and other molecules with limited gastrointestinal permeability.
Quality control of Salcaprozate Sodium can include identity testing by infrared spectroscopy, chromatographic identification, assay, related substances, water content, residual solvents, inorganic residue and microbiological quality where applicable.
Publicly available pharmaceutical specifications for SNAC commonly use HPLC-based assay and related-substance testing. One pharmaceutical reference specification reports 98.0%–102.0% assay on a dried basis, while other commercial specifications differ in their water, impurity and residual-solvent limits. These should therefore be treated as product-specific specifications rather than universal pharmacopoeial limits.
Salcaprozate Sodium is relevant to pharmaceutical manufacturers working on oral absorption-enhancement technologies, peptide formulations and advanced drug-delivery systems. Manufacturing quality programs can include validated analytical methods, controlled raw materials, batch traceability and appropriate pharmaceutical documentation.
Typical documentation may include a Certificate of Analysis (CoA), specification sheet, Safety Data Sheet (SDS/MSDS), Certificate of Origin, residual-solvent data and applicable regulatory documentation.
Salcaprozate Sodium should be protected from moisture and stored in packaging appropriate to the validated stability specification. Commercial pharmaceutical references recommend controlled storage, including 2–8°C for certain grades, while other suppliers specify room-temperature storage. Therefore, the final storage condition should follow the actual validated API/excipient specification and stability data, rather than applying one commercial condition universally.
Salcaprozate Sodium is an important pharmaceutical absorption-enhancing excipient with established use in oral drug-delivery technology. Its relevance to oral semaglutide and other macromolecule-delivery approaches makes it an important material for pharmaceutical formulation and drug-development programs. Consistent control of identity, assay, related substances, moisture, residual solvents and microbiological quality supports reliable pharmaceutical use.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 1.0% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |