Sucralfate CAS NO.54182-58-0

tem

Specification

Result

Assay (dried substance)

98.5% ~ 101.5%

99.5%

Specific rotation[α]D20

+6.3 ~ +7.3°

+6.8°

Loss on drying, %

≤0.30

0.20

Residue on ignition, %

≤0.10

0.06

Heavy metals (Pb), ppm

≤10

8

Arsenic (As2O3), ppm

≤1

0.5

State of solution, %

≥98 (2.5% aqueous solution)

98.6

pH

4.5 ~ 6.0

5.2

Sulfate (SO4), %

≤0.020

<0.020

Chloride (Cl), %

≤0.020

<0.020

Ammonium (NH4), %

≤0.10

<0.10

Iron (Fe), ppm

≤10

5

Other amino acids, %

≤0.5

0.2

Aerobic plate count, cfu/g

≤1000

<1000

Pathogenic bacteria, cfu/g

Negative

Conforms

Conclusion

Conforms to AJI2002/FCCV/USP29