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Product Name: Moxidectin

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CAS No: 113507-06-5

Melecular Formula: C37H53NO8

Molecular Weight: 639.8186


Certificate of Analysis

Product Name

Moxidectin

Reference

USP 38 monographundefinedMoxidectin>

Shelf Life

3 years

Testing Item

Specification

Result

1.Appearance

White or pale yellow crystalline powder,No visible evidence of contamination by foreign materials


Meet test


2.Identification

a) IR:The spectra of the sample and the standard should be the same


Meet test

b) HPLC:The relative RT of the main peak in the sample solution should be the same as that in the standard solution


Meet test

3.Appearance of Solution

Conform to USP requirement

Meet test

4.Water

≤1.3%

0.3%


5.Related Substances


Early-Eluting Impurities by HPLC
a)Moxidectin Butenyl analog(RRT0.5) ≤1.5%


0.5%

b)5-Demethyl moxidectin(RRT0.7) ≤0.5%

0.2%

c)Moxidectin pentenyl analog(RRT0.75) ≤1.5%

0.9%

d) Moxidectin 17a-epomer(RRT0.9)≤2.5%

undefined0.1%

e)Sum of moxidectin 19-S-17a-ene and moxidectin ethyl isomers(RRT1.3~1.5 )   ≤1.7%


0.7%

f)Mibemycin B analog (moxidectin open ring) ≤1.5%

undefined0.1%

g)Any other individual impurity eluting before mibemycin B analog (Moxidectin open ring) ≤0.5%


undefined0.1%

Late-eluting impurities by HPLC
a)Moxidectin Deoxydiene and 4-methylthiomethoxy- moxidectin(RRT2.0)≤1.0%


undefined0.5%

b)20b-methylthiomoxidectin (RRT2.2)   ≤0.5%

undefined0.1%

c)20-Nitrobenzoylmoxidectin (RRT3.4) ≤0.5%

undefined0.1%  

d)Any other individual impurity eluting after the mibemycin B anaolg  (Moxidectin open ring,RRT:1.4) ≤0.5%


0.2%

Total Organic impurities by HPLC: ≤7.0%
Calculate sume of all impurities found in the tests for organic impurities(Early-eluting impurities)and Organic impurities (late-eluting impurities in the portion of moxidectin taken


2.2%

6.Heavy  Metals

≤20ppm

undefined20 ppm

7.Residue on Ignition

≤0.2%

0.1%

8. Assay

92.0~102.0%(anhydrous)

98.1%


9.Residual Solvents

a)Acetone: ≤5000ppm
b)Ethanol: ≤5000ppm


undefined50ppm

c)Heptane: ≤ 5000ppm

283 ppm

d)Dichloromethane: ≤600 ppm

undefined50 ppm

e)BHT: 0.1~0.6%

0.34%

Conclusion: The product fulfills the USP 38 Monograph
The product are manufacturered in cGMP plant

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