| ≥1 piece |
|
RESULT OF ANALYSIS |
|||
|
ITEMS |
STANDARDS |
RESULT |
|
|
Identification |
positive reaction |
comply |
|
|
Loss on drying |
MAX 0.5% |
0.18% |
|
|
Residue on ignition |
MAX 0.1% |
0.07% |
|
|
Heavy metal |
MAX10ppm |
comply |
|
|
Melting point |
117-120 °C |
118.-119 °C |
|
|
Clarity and degree of opalescence of liquids |
1 % ethanol and chloroform Solution |
comply |
|
|
Particle size |
80-120mesh |
comply |
|
|
related substances |
Max0.1% |
comply |
|
|
residual solvents: ethanol |
Max 1000ppm |
comply |
|
|
total viable count |
Max3000cfu/g |
comply |
|
|
yeast and moulds |
Max300cfg/g |
comply |
|
|
e. coli |
Absence/g |
comply |
|
|
salmonella |
Absence/25g |
comply |
|
|
HPLC |
≥99.5% |
99.55% |
|
|
. CONCLUSION:Comply with USP |
|||
|
DIRECTOR |
INSPECTOR |
||