Salcaprozate Sodium; CAS 203787-91-1

Appearance

White to off-white powder

Identification

HPLC: in the chromatogram recorded under the content check item, the retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay.

Hygroscopicity

Extremely hygroscopic

Solubility

Easily soluble in methanol and water, soluble in 1-methyl-2-pyrrolidone, slightly soluble in ethanol, and almost insoluble or insoluble in isopropanol.

PH

6.5~8.5

Moisture

≤ 2.0%

Related Substances

SNAC-02 ≤ 0.1%

2488 A ≤ 0.1%

SNAC-01 ≤ 0.1%

SNAC-03-B ≤ 0.1%

SNAC-03-F ≤ 0.1%

SNAC-02-C ≤ 0.1%

Other single impurity ≤ 0.1%

Total impurities ≤ 1.0%

N-(2-Hydroxyethyl) ethylenediaminetriacetic acid ≤ 0.1%

Residual Solvents

Methanol ≤ 0.3%

Ethanol ≤ 0.5%

N-heptane ≤ 0.5%

Ethyl acetate ≤ 0.5%

Dimethyl carbonate ≤ 0.1%

Isopropanol ≤ 0.5%

N, N-dimethylformamide ≤ 0.088%

Total Aerobic Microbial Count

≤ 1000cfu/g

Yeasts & Molds

≤ 100cfu/g

E.Coli

Negative in 1g

Assay (on anhydrous basis)

97.0%~103.0%