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Certificate
of Analysis
Alpha Lipoic Acid (Thioctic acid)
Molecular formula: C8H14O2S2
Molecular
weight: 206.33
Structural formular:
Batch No. 020814
MFG Date: 8/12/2002
EXP
Date: 8/12/2004
Quantity: 100
kgs
Report Date: 8/20/2002
Test Items
Specifications
Test Results
Appearance
Yellowish crystalline powder
Conforms
Identification
Lead Acetate test and UV, IR:Positive
Conforms
Melting Point(BP)
60℃-62℃
62℃
Solubility(IN
NaOH)
Clear and pale yellow
Conforms
Residue on ignition
≤0.10%
0.10%
Heavy Metals
≤10
ppm
<10ppm
Chloride
≤0.07%
<0.07%
Loss on Drying
≤0.50%
0.16%
Assay(by HPLC)
≥99.00%
99.52%
Specific optical rotation
-1--+1
Conforms
Related substance (by HPLC)
Single impurity
≤0.20%
0.15%
6,8-Epitrithloctic acid
≤0.30%
0.26%
Total impurities
≤0.50%
0.43%
Polymere
≤0.50%
<0.50%
Residual solvents(GC)
Toluene
≤5
ppm
<5
ppm
Cyclohexane
≤0.20%
0.11%
Ethylacetate
≤5
ppm
<5
ppm
Microbiology
Total aerobic counts ≤1000CFU/g
<100CFU/g
Mould
≤100CFU/g
Not detectable
Ecol
Not detectable
Not detectable
Salamonellas
Not detectable
Not detectable
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