Product Brief Introduction
Product name: Gamithromycin
CAS: 145435-72-9
MF: C40H76N2O12
MW: 777.04
Product Specification
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Appearance |
White to off-white crystalline powder |
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Identification |
IR: the infrared absorption spectrum of the sample complies with the reference standard. |
|
Solubility |
Very freely soluble in dichloromethane, soluble in ethanol, practically insoluble in water. |
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Clarity and Color of Ethanol Solution |
Solution is clear or not more opalescent than reference suspension1 and not more intensely colored than reference solution Y1. |
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Specific Rotation |
-40.0°~ -44.0° |
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PH |
9.0-11.0 (2mg/ml methanol-water (1:1)) |
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Moisture |
≤ 2.0% |
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Residue on Ignition |
≤ 0.1% |
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Related Substances (HPLC) |
IMB-2≤0.5% |
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IMB≤0.5% |
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JM-1≤0.5% |
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JM-3≤0.5% |
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JM-4≤0.5% |
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JM-5≤0.5% |
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JM-6≤0.2% |
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JM-7≤0.2% |
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Other single impurity≤ 0.2% |
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|
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Total impurities ≤ 2.0% |
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Heavy Metals |
≤ 10.0ppm |
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Palladium |
≤ 1.0ppm |
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Residual Solvents |
Acetic acid ≤ 5000ppm |
|
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Ethanol ≤ 5000ppm |
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Methanol ≤ 3000ppm |
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Acetone ≤ 5000ppm |
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Propanal ≤ 5000ppm |
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Diisopropylamine ≤ 5000ppm |
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Dichloromethane ≤ 600ppm |
|
Bacterial Endotoxins |
≤ 0.25 EU/mg |
|
Total Aerobic Microbial Count |
≤ 2000cfu/g |
|
Yeasts & Molds |
≤ 200cfu/g |
|
E.Coli |
Negative in 1g |
|
Staphylococcus Aureus |
Negative in 1g |
|
Pseudomonas Aeruginosa |
Negative in 1g |
|
Assay (on anhydrous basis) |
98.0%~102.0% |
