CERTIFICATE OF ANALYSIS Quality Control Code: 300500034

CLONAZEPAM MICRONIZED
Rev.: 05 Page 1/ 1
Manuf. Date:
APRIL/2013
Expiry Date:
APRIL/2017

TESTS RESULTS SPECIFICATIONS

. Description



. Solubility





. Identification
I.R.:

. Melting Point

. Loss on Drying

. Sulfated Ash



. Related Substances (HPLC)
Impurity A:
Impurity B:
Unknown impurity:
Total impurity:

. Assay (Potenciometric)

. Residual Solvents
Acetonitrile:
Toluene:
Hexane:
Acetone:

. Granulometry

. Conforms



. Water: Conforms
. Alcohol: Conforms
. Methanol: Conforms




. Conforms

. 239.9C

. 0.2%

. 0.0%




. <0.1%
. <0.1%
. <0.1%
. <0.2%

. 100.6%



. <41 ppm
. <89 ppm
. <29 ppm
. <500 ppm

. 100.0%

. Slightly yellowish crystalline
powder.

. Practically insoluble in water;
slightly soluble in alcohol and
methanol




. Conforms to standard

. 237 to 240C

. Not more than 0.5%

. Not more than 0.1%




. Not more than 0.1%
. Not more than 0.1%
. Not more than 0.1%
. Not more than 0.2%

. 99.0% to 101.0%



. Not more than 410ppm
. Not more than 890ppm
. Not more than 290ppm
. Not more than 5000ppm

. Minimum 90.0% < 25m
Package and Storage: Keep the recipient hermetically closed and avoid temperature higher than 30C

Approved by Quality Control Department