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Levamisole hydrochloride cetirizine 130018-87-0

Inquiry
  Post Date: Jan 15,2019
  Expiry Date: Jan 15,2020
  Detailed Description: Cas No. :130018-87-0 Specification:

Items
Acceptance criteria
Results
Character
Appearance: White or almost white powder.
Almost white powder
Solubility: Slightly soluble in water, freely
soluble in dilute acetic acid and in methanol,
slightly soluble in alcohol.
Complies
Identification
A.Specific optical rotation: –30.0º~-33.5º
(dried substance)
–33.3º
B.Infrared absorption spectrophotometry:
The IR spectrum is consistent with that
obtained with Levodropropizine CRS.
Complies
Tests
pH
9.2~10.2
9.4
Impurity B and related
substances
Impurity B: ≤ 0.5%
≤ 0.1%
Any other impurity: ≤ 0.1 %
≤ 0.1%
Total impurities: ≤ 0.6 %
≤ 0.1%
Impurity C
≤ 5 ppm
≤ 5ppm
Enantiomeric purity
Impurity A: ≤ 2 %
0.2 %
Loss on drying
≤ 1.0 %.
≤ 0.1%
Sulphated ash
≤ 0.2 %
≤ 0.1%
Assay
98.5% ~ 101.0%(dried substance)
99.7%
Conclusion
The product meets the specification of EP7.0

  CAS Registry Number:

130018-87-0
  Synonyms: ;Leocetirizine Hydrochloride;Levocetirizine 2Hcl;Levocetirizine Dihcl;Levocetirizine Hcl;Levocetrizine Dihydrochloride;[2-[4-[(R)-(4-Chlorophenyl)Phenylmethyl]-1-Piperazinyl]Ethoxy]-Acetic Acid Dihydrochloride;Levocetrizinehcl;Levocitirizine Dihydrochloride;Levo Cetirzine Dihydrochloride;Levocitirizine Dihcl;4-{4-[(S)-(4-Chlorophenyl)(Phenyl)Methyl]Piperazin-1-Yl}Butanoic Acid Hydrochloride (1:1);Levocetirizine Hydrochloride;Levocetrizine Hydrochloride;Levocitirizine 2Hcl;
  Molecular Formula: C21H26Cl2N2O2
  Molecular Weight: 409.34934
  Molecular Structure: 130018-87-0 Levocetirizine dihydrochloride

  Company: Wuhan Benjamin Pharmaceutical Chemical Co.,Ltd     [ China ]          
  Contact: Miss Wang
  Tel: 027-50661278
  Fax: 027-87569548
  Email: sales03@benjaminpharmchem.com
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