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首页 > Pharmaceutical Materials > 99.5% up by HPLC Salcaprozate sodium/SNAC 203787-91-1
99.5% up by HPLC Salcaprozate sodium/SNAC 203787-91-1
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更新 2025-08-13 18:51
 
详细信息

Grade: Pharmaceutical Grade

Factory Location: Xiamen

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Monthly Production Capacity: 10tons/year

Contract Manufacturing: CRO,CMO

Packaging Information: 25kg/bag

Delivery Lead Time: 7 days after payment

Sample Provided: yes

Payment Terms: L/C

  

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

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.