Tiamulin hydrogen famarate CAS 55297-96-6

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Model: MOS55297-96-6
CAS: 55297-96-6
Molecular formula: C32H51NO8S
Molecular weight: 609.8142
Boiling point: 563°C at 760 mmHg
Flash point: 294.3°C
Vapour Pressur: 5.06E-15mmHg at 25°C
Melting Point: 147-148℃

Tiamulin hydrogen famarate (CAS 55297-96-6)

ITEM STANDARD RESULT
Description White or almost white crystal powder Conform
Identification HPLC: The retention time obtained from the solution corresponds 

to that obtained from the standard solution infra-red spectrum: infra-red spectrum 

of the sample corresponding to that of the reference standard

Conform
Specific rotation +24° ~ +28° +26°
PH 3.1 ~ 4.1 3.7
Loss on drying ≤ 0.5% 0.1%
Melting point 143℃ ~ 152℃ 147℃
Residue on ignition ≤ 0.1% 0.02%
Heavy metal ≤ 0.001% Conform
Absorbance 650 nm ≤ 0.030 0.003
400 nm ≤ 0.150 0.020
Chromatographic purity Not more than 1.0% of any identified impurity is found, not

 more than 0.5% of any unidentified impurity is found, and not 

more than 2.0% of tatal impurities is found

Conform
Residual solvent ≤ 0.5% < 0.30%
Fumarate 83.7MG ~ 87.3MG 86.8MG
Assay Basis on drying 97.0% ~ 102.0% 99.0%

Tiamulin fumarate is the fumarate Tiamulin, white or almost white crystalline powder, odorless, tasteless, for chicken chronic respiratory disease, swine mycoplasma pneumonia and Haemophilus pleura pneumonia, can also be used for pig secret dysentery caused by spirochetes.

Calculated on the anhydrous, containing tiamulin (C28H47NO4S) shall be not less than 98.0%.

[Characters]

This product is soluble in methanol or ethanol, dissolved in water, slightly soluble in acetone, almost insoluble in hexane. Melting point melting point of this product (Appendix 11) is 143 ~ 149 ℃. Specific rotation to take this product, accurately weighed, add dioxane dissolved and quantitatively diluted per 1ml solution containing 2mg determination (Appendix 13), specific rotation of + 24 ° to + 27 ° law.

Discriminate

[Check] acidity to take this product, made by adding water solution of 50mg per 1ml of determination (Appendix 29) according to the law, pH value should be 3.1 to 4.1.

Related substances to take this product, add ethanol produced per 1ml solution containing 3mg, as the test solution. Another precise amount of the check amount, diluted with ethanol per 1ml containing 0.3mg of solution as a control solution. Thin layer chromatography (Appendix 20) test, learn the two solutions of 10 l, respectively, the same silica gel GF254 TLC plate with butyl acetate – methanol – ammonium hydroxide? (20: 2: 0.4) as the agent, started, drying, UV light (254nm), under review for the test solution, such as significant impurity spots, the color control solution significantly spots, not deeper.

Absorption of this product, accurately weighed, dissolved in water and quantitatively diluted per 1ml solution containing 50mg, according to spectrophotometry (Appendix 16) was measured for absorbance should be not more than 0.03 at a wavelength of 650nm at 400nm Determination of wavelength, absorbance should not exceed 0.15.

Water to take the goods, according to determination of moisture content (Appendix 36 of the first method) Determination of water containing not more than 1.0%.

Residue on ignition to take this product 1.0g, according to inspection (Appendix 37), and the remaining residue should not exceed 0.2%.

Heavy metals residue on ignition under the residue left over, according to inspection (Appendix 34 of the second method), containing heavy metals should not exceed ten millionths.

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