Salcaprozate sodium/SNAC 203787-91-1

99.5% up by HPLC, US-DMF

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Product Details

Product Information

Product name	Salcaprozate sodium; SNAC; sodium,8-[(2-hydroxybenzoyl)amino]octanoate
CAS No.	203787-91-1
Molecular Formula	C15H22NNaO4
Molecular Weight	303.33
Quality Standard	99.5% up by HPLC, US-DMF
Appearance	White to off-white powder

COA

Test Items	Specifications	Results
Appearance	White to off-white powder	Off-white powder
pH	6.5-8.5	7.5
Humidification	Extremely humidifying	Conforms
Identification	The retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution	Conforms
Identification	IR spectrum corresponds to that of the reference standard	Conforms
Solubility	Freely soluble in methanol and water, soluble in 1-methyl-2-pyrrolidone, slightly soluble in ethanol, almost insoluble or insoluble in isopropanol	Conforms
Sodium ion content	7.17%-8.09%	7.58%
Water	≤2.0%	0.95%
Related substances I
SAL-02	≤ 0.1%	Not detected
SAL-SM1	≤ 0.1%	Not detected
SAL-01	≤ 0.1%	Not detected
SAL-03-B	≤ 0.1%	Not detected
SAL-03-F	≤ 0.1%	Not detected
SAL-02-C	≤ 0.1%	0.02%
Any single unspecified	≤ 0.1%	0.02%
Total impurities	≤ 1.0%	0.06%
Related substances II
HEDTA	≤ 0.1%	Not detected
Residual solvents I
Methanol	≤ 0.3%	Not detected
Ethanol	≤ 0.5%	Not detected
N-heptane	≤ 0.5%	0.0005%
Ethyl acetate	≤ 0.5%	Not detected
Dimethyl carbonate	≤ 0.1%	Not detected
Isopropanol	≤ 0.5%	0.01%
N,N-dimethylformamide	≤ 0.088%	Not detected
Residual solvents II
Methyl Chloride	≤ 0.0005%	Not detected
Ethyl Chloride	≤ 0.0005%	Not detected
Benzene	≤ 0.0002%	Not detected
Assay	97.0% -103.0% of C₁₅H₂₀NNaO₄. calculated on the dried basis.	100.1%
Microbial Limit
Total aerobic microbial count	≤ 1000 cfu/g	< 10cfu/g
Total yeasts and molds count	≤ 100 cfu/g	10cfu/g
Conclusion	The product complies with the In-house specification

Usage

Salcaprozate Sodium (SNAC)‌

SNAC (salcaprozate sodium) is a clinically validated oral absorption enhancer designed to improve the bioavailability of peptide drugs such as semaglutide (Rybelsus®). Its dual-action mechanism includes:

1. ‌Enhanced Lipophilicity and Permeability‌

By forming ‌non-covalent complexes‌ with macromolecules (e.g., insulin, heparin, GLP-1 agonists), SNAC increases drug lipophilicity, facilitating passive transcellular transport across intestinal epithelial cells. This process reduces gastric acid/enzyme degradation and enhances intestinal absorption efficiency.

2. ‌Gastric Environment Modulation‌

SNAC transiently elevates gastric pH, suppresses pepsin activity, and stabilizes drugs in monomeric forms to optimize permeability.

3. ‌Key Applications‌

（1）‌Semaglutide Formulations‌: Critical for oral Rybelsus® production, SNAC enables >0.5% bioavailability (vs. <0.01% without enhancers)

（2）‌Insulin/Heparin Delivery‌: Reduces degradation rates by >70% and extends plasma half-life

SNAC’s unique profile positions it as a cornerstone excipient for next-generation oral biologics, with validated safety and formulation flexibility.