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Dorzolamide Hydrochloride

Product name: Dorzolamide Hydrochloride
CAS: 130693-82-2
化学品名: Xylometazoline
Category: Pharmaceutical Intermediates
Specification:
Items
Specifications
Appearance
White or white alike crystalline powder
Identification
1.      IR spectrum
2.      by HPLC
3.      Chlorides
Water
≤0.5%
Limit of dorzalamide HCl related compoud”A”
≤0.5%
Chromatographic purity
individual impurity
Total impurity
 
≤0.1%
≤0.5%
Residue on ignition
≤0.1%
Heavy metal
≤10ppm
Organic volatile impurities
Acetone : ≤5000ppm
Acetonitrile : ≤410ppm
Ethyl acetate: ≤5000ppm
Hexane : ≤290ppm
Methanol : ≤3000ppm
Tetrahydrofuran : ≤720ppm
Toluene : ≤890ppm
Iso propyl alcohol: ≤5000ppm
Choroform : ≤60ppm
1,4-dioxane: ≤380ppm
Trichloroethene : ≤80ppm
Dichloromethane : ≤600ppm
Assay(on anhydrous basis)
99.0~101.0%(C10H16N2O4S3.HCl)
Conclusion It complies with  USP30.

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