Neomycin Sulfate CAS NO.1405-10-3

TEST ITEMS

SPECIFICATIONS

TEST RESULTS

Characters

White to slight yellow powder, odorless and hygroscopic. In solution it is dextrorotatory. Free of foreign particles.

Meet test

Identification

A;B;C The Positive reaction

Complies

Solubility

Freely soluble in water,very slightly in alcohol,insoluble and inether

Meet test

Ph

5.0 – 7.5

6.6

Loss on drying

≤ 8.0%

4.7%

Assay

Anhydrous potency≥600ug/mg

678ug/mg

Microbiological testing

a)Microbial count:≤10FCU/g at 25°C

<10CFU/g

b) Microbial count:≤10CFU/g at 35°C

<10CFU/g

b)No.of fungi and mould: ≤50CFU/g

Absence

c)Pathogenic bacteria Staphylococcus Aureus:Absence/g Pseudomonas Aeruginosa:Absence/g E.Coli:Absence/g

Absence

Absence

Absence

CONCLUSION: COMPLY WITH USP.35