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5 Kilogram |
Negotiable |
Levocarnitine L-Carnitine base L-carnitine injection
GMP ep quality
Characteristics
White or almost white crystalline powder or
colorless crystal ,hygroscopic.
White crystalline
powder,hygroscopic.
Solubility
Freely soluble in water ,soluble in warm
ethanol (96%),practically in insoluble in
acetone
Meet the requirement
Identification IR:Complies Complies
Assay (on dry basis) 98.0%~102.0% 98.3%
Specific Rotation
(anhydrous substance)
-29.0°~-32.0° -31.0°
PH 6.5~8.5 7.6
Water Content ≤ 1.0% 0.85%
Residual Solvents
Acetone ≤5000ppm 58ppm
Ethanol ≤5000ppm 452ppm
Methanol ≤3000ppm N,D
Heavy Metals ≤10ppm <10ppm
Chloride ≤200ppm <200ppm
Sulfate ≤300ppm <300ppm
Sulphated ash ≤0.1% 0.01%
Clarity of solution Clear Clear
Color of solution Colorless Colorless
Related substance
Impurity A≤0.5%
Any other impurity≤0.1%
0.01%
0.01%
Total plate count ≤1000cfu/g 30cfu/g
Yeast & mold ≤100cfu/g 10cfu/g
E.coli N,D N,D
Escherichia coli N,D N,D
Staphylococcus aureus N,D N,D
Bacterial endotoxin <0.1EU/mg <0.1EU/mg
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