99.5% up by HPLC Salcaprozate sodium/SNAC 203787-91-1

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