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Ivermectin

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  Post Date: Feb 18,2013
  Expiry Date: Feb 18,2014
  Detailed Description: Cas No. :70288-86-7 Batch No.Yw201006002 Batch size 100kg MFG date 2010.06.04
Sampling date 2010.06.04 Test date 2010.06.04 Report date 2010.06.05
Reference EP6 R test date 2012.06.04
Testing items Specification.EP Test results
Appearance White or yellowish-white crystalline powder White-crystalline powder
Appearance of solution The solution is clear and mot more intensely coloured than reference solution BY7 clear
Identification IR Corresponds with that of CRS standard complies
HPLC The retention tine for H2B1a and H2B1b corresponds to CRS Complies
Water Not more than 1.0% 0.5
Ethanol Not more than 5.0% 3.45
Formamide Not more than 3.0% 2.73
Ratio H2B1a/(H2B1a+H2B1b), a Not more than 90.0% 97.95
Assay(H2B1a+H2B1b) (Anhydrous and solvent-free substance) Between 95.0% and 102.0% 95.40

Related compounds Theindividual impurity(RRT1.3-1.5)
Not more than 2.5% 0.8 1.40
Any other individual impurity not more than 1% 0.1 0.49 0.02 0.50 0.55 0.03
Sum of total impurity not more than 5% 3.89
Disregard peaks less than 0.05% 0.05
Heavey metals Not more than 0.002% <0.002
Sulphated ash Not more than 0.1 <0.1
Specific optical rotation(Anhydrous and solvent-free substance) Between -17°-20°-18°
Residual solvents(toluene) Not more than 890ppm <890ppm
Conclusion Complies with the requirement of EP6
Reported by Reviewed by Approved by

  CAS Registry Number:

70288-86-7

  Synonyms: ;22,23-dihydroavermectin;mk-0933;22,23-DIHYDROAVERMECTIN B1;Ivermectin Injection;
  Molecular Formula: C95H146O28
  Molecular Weight: 1736.15894
  Molecular Structure: 70288-86-7 ivermectin

  Company: Jily Enterprise Company Limited     [ China ]        
  Contact: Cindy Lee
  Tel: +86-311-89800519
  Fax:
  Email: jily.enterprise@gmail.com
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