1. Product Name: Salcaprozate Sodium

2. Alias: SNAC; Salcaprozate Sodium; Salcaprozate sodium; Salcaprozate Sodium (SNAC); sodium 8-(2-hydroxybenzamido)octanoate; sodium,8-[(2-hydroxybenzoyl)amino]octanoate; SODIUM 8-(2-HYDROXYBENZAMIDO)OCTANOATE (SNAC); SNAC,sodium 8-[(2-hydroxybenzoyl)amino]octanoate; Octanoic acid, 8-[(2-hydroxybenzoyl)amino]-, monosodium salt

3. CAS No.: 203787-91-1

4. EINECS: 231-019-4

5. Chemical Formula: C₁₅H₂₀NNaO₄

6. Molecular Weight: 301.31

7. Storage Condition: Stored in unopened containers at room temperature.

8. Physical & Chemical Properties: Salcaprozate sodium (SNAC) is an oral absorption enhancer with potential as a delivery agent for oral forms of heparin and insulin. Salcaprozate sodium increases lipophilicity induced by non-covalent macromolecular complexation, thereby increasing passive transcellular penetration of intestinal epithelial cells.

9. Application: It is an absorption enhancer for dicarbonate phosphate compounds, which is used for treating gastrointestinal diseases, especially for gastrointestinal diseases caused by malabsorption of dicarbonate phosphate compounds.

10. Specifications:

Appearance: White to yellowish or pinkish crystalline powder

HPLC: The retention time of the main peak of the Sample solution corresponds to that of the Standard solution.

UV: The maximum absorption should be at the wavelength of 301nm and 238nm, and the minimum absorption should be at the wavelength of 228nm.

IR: Corresponding to Cholesterol CRS

Relevant substance:

Impurity A≤0.15%

Impurity E≤0.15%

Impurity G≤0.5%

The maximum unknown single impurity≤0.1%

Total impurities≤1.0%

Water: ≤2.0%

Heavy Metals: ≤20ppm

Arsenate: ≤0.0002%

Residual Solvents:

Methyl Alcohol≤0.5%

Isopropanol≤0.5%

DMF≤0.088%

Ethyl Alcohol≤0.5%

Benzene≤0.0002%

Microbial Contamination:

TAMC≤1000CFU/g

TYMC≤100CFU/g

E. coli should not be detected per 1g

Residue on Ignition: ≤0.1% w/w

[Assay] Sodium: 7.1%~8.1%(On Dried Basis)

Salcaprozate Sodium: 98.0%~102.0%(On Dried Basis)