PRODUCT NAME: AMBROXOL HCL EP6.0

EXPIRY DATE:5 years

CAS NO.:

ITEMS

SPECIFICATION

RESULTS

APPEARANCE

WHITE OR YELLOWISH CRYSTALLINE POWDER

CONFORM

APPEARANCE OF SOLUTION

NOT MORE INTENSELY COLORED THAN THE REFERENCE SOLUTION Y6

CONFORM

MELTING POINT

235-240°C

235.1-239.1°C

SOLUBILITY

WATER

METHANOL

METHYLENE CHLORIDE

SPARINGLY SOLUBLE

SOLUBLE

PRACTICALLY INSOLUBLE

CONFORM

CONFORM

CONFORM

IDENTIFICATION

A)     UV ABSORPTION

B)     IR SPECTRUM

C)     THIN LAYER CHROMOTOGRAPHY

D)     CHLORIDES TEST

3.2-3.4 RATIO

CONFORM

CONFORM

CONFORM

CONFORM

TESTS

A)     RELATED SUBSTANCE

i)                    SINGLE IMPURITY

ii)                  TOTAL IMPURITY

B)     HEAVY METALS

C)     LOSS ON DRYING

D)     SULPHATED ASH

E)     PH(1% AQUEOUS SOLUTION)

0.1%

0.3%

≤20PPM

≤0.5%

≤0.1%

4.5-6.0

0.02%

0.04%

<20PPM

0.07%

0.04%

5.13

PARTICLE SIZE

           100%≤50μ

<45μ

ASSAY

99.0%~101.0%

99.5%

SUMMARY

EP6 STANDARD ,CONFORM THE STIPULATION