RELEASE REQUIREMENT:ACCORDING TO usp31
|
ANALYSIS |
SPECIFICATION |
RESULT |
METHOD |
|
Appearance |
Orange to red or Yellow viscous fluid (liquid) |
Complies |
Visual |
|
Identification
IR
Chemical test |
Sample spectrum exhibits maxima only at the same wavelengths as that of a similar preparation of the Reference Standard.
A blue color appears. |
Complies
Complies |
|
|
Water(KF) |
5.0% max |
2.61% |
USP31<921 I> |
|
Heavy Metals |
<20ppm |
6.80ppm |
USP31<231 II> |
|
Arsenic |
3ppm max |
0.40ppm |
|
|
Solubility
(Water 0.1%w/v)
Coenzyme Q10 |
95.0% min
|
100% |
Distilled water is used to prepare water soluble Coenzyme Q10 solution (10ml) whose concentration is 1mg/ml . The solution should be extracted by ultrasonic for 1 hour and be centrifugal for 10 minutes at the speed of 2000r/min. The content of clear solution should be measured. |
|
Dispersity
(Water 0.1%w/v) |
No suspended materials and sediments |
Complies |
Distilled water is used to prepare water soluble Coenzyme Q10 solution (10ml) whose concentration is 1mg/ml . The solution should be placed for 30 minutes after 15 seconds vibration. Appearance should be observed. No suspended materials and sediments should be found. |
|
Total Plate Count |
<1000cfu/g |
270cfu/g |
USP31 |
|
Yeast & Mold |
<100cfu/g |
52cfu/g |
USP31 |
|
E.Coli |
Negative |
Negative |
USP31 |
|
Salmonella |
Negative |
Negative |
USP31 |
|
AssayCoenzyme Q10 |
10.0% min |
10.72% |
USP31 |
| 
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