(R)-7-(3-Aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride (+)-7-((3R)-3-Aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride BOL-303224-A
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Miedykol was founded by Mikem (Shandong) Biopharmaceutical Science and Technology Co., Ltd. in 2020 with the vision of creating a healthy world for all. It is a brand by Mikem Chemical Ltd. Co., a speciality chemicals supplier and solutions provider headquartered in America who embraces the vision of better living with green chemistry. Over the years, we have grown into an impressively influential player who is capable of sending our products to every corner of the world through the automatic production, packaging system, on-stop delivery and transportation service. Today, we continue to innovate and expand our offerings to meet the evolving needs of our customers.
ITEM |
STANDARD |
RESULT |
Appearance
|
Off-White or light yellow powder |
Light yellow powder |
Solubility |
Slightly soluble in methanol |
Conform |
Identification |
1.The retention time of the principal peak obtained with the test solution is identical with the reference solution |
Conform |
|
2.The infrared spectrogram obtained with the test solution is identical with the reference solution |
Conform |
Particle size |
90% particles not more than 15u m |
Conform |
Impurity A |
≤0.15% |
N.D |
Impurity B |
≤0.15% |
N.D |
Other individual impurity |
≤0.10% |
N.D |
Total impurity |
≤0.5% |
N.D |
N,N-Dimethylformamide |
≤0.088% |
N.D |
Ethanol |
≤0.5% |
0.0029% |
Tetrahydrofuran |
≤0.072% |
N.D |
Acetonitrile |
≤0.041% |
0.0039% |
Methanol |
≤0.3% |
0.0076% |
Triethylamine |
≤0.016% |
N.D |
Toluene |
≤0.089% |
N.D |
Loss on drying |
≤0.5% |
0.07% |
Residue on ignition |
≤0.2% |
0.05% |
Heavy metals |
≤0.002% |
<0.002% |
Sterility test |
Should meet the requirements |
Conform |
Assay (on dried base) |
≥98.5% |
99.6% |
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