RELEASE REQUIREMENT:ACCORDING TO usp31
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ANALYSIS
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SPECIFICATION
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RESULT
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METHOD
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Appearance
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Orange to red or Yellow viscous fluid (liquid)
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Complies
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Visual
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Identification
IR
Chemical test
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Sample spectrum exhibits maxima only at the same wavelengths as that of a similar preparation of the Reference Standard.
A blue color appears.
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Complies
Complies
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Water(KF)
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5.0% max
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2.61%
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USP31<921 I>
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Heavy Metals
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<20ppm
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6.80ppm
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USP31<231 II>
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Arsenic
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3ppm max
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0.40ppm
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Solubility
(Water 0.1%w/v)
Coenzyme Q10
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95.0% min
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100%
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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.
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Dispersity
(Water 0.1%w/v)
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No suspended materials and sediments
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Complies
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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.
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Total Plate Count
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<1000cfu/g
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270cfu/g
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USP31
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Yeast & Mold
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<100cfu/g
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52cfu/g
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USP31
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E.Coli
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Negative
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Negative
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USP31
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Salmonella
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Negative
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Negative
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USP31
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AssayCoenzyme Q10
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10.0% min
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10.72%
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USP31
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