PRODUCT  NAME:   STREPTOMYCIN SULFATE STERILE EP6

EXPIRY DATE:4 years

CAS NO.: 223-286-0

ITEMS

SPECIFICATIONS

RESULTS

CHARACTERS

A WHITE OR ALMOST WHITE POWDER

A WHITE  POWDER

IDENTIFICATION

A  TLC,COMPLIES

B REACTION WITH FERRIC CHLORIDE SOLUTION,COMPLIES

C REACTION WITH α-NAPHTHOL SOLUTION AND STRONG SODIUM HYPOCHLORITE SOLUTION,COMPLIES

D REACTION WITH α-NAPHTHOL SOLUTION,COMPLIES

E REACTIONS OF SULPHATES,COMPLIES

COMPLIES

COMPLIES

COMPLIES

COMPLIES

COMPLIES

APPEARANCE OF SOLUTION

CLARITY:≤2^#

COLOUR:NO MORE INTENSE THAN REFERENCE SOLUTION 3

<1^#

6^#

PH

4.5~7.0

5.6

STREPTOMYCIN B

≤3.0%

<3.0%

LOSS ON DRYING

≤7.0%

3.7%

SULPHATED ASH

≤1.0%

0.5%

SULPHATE

18.0% ~21.5%

19.2%

COLORIMETRIC TEST

≥90.0%

99.8%

ASSAY(DRIED SUBSTANCE)

≥720IU/MG

763 IU/MG

STERILITY

STERILITY

STERILITY

BACTERIAL ENDOTOXINS

<0.25IU/MG,COMPLIES

COMPLIES

ABNORMAL TOXICITY

1MG/0.5ML,COMPLIES

COMPLIES

SODIUM METABISULPHITE

≤0.3%

0.012%

CONCLUSION

COMPLIES WITH PH EUR 6.0