Azithromycin Dihyrate (CAS: 83905-01-5)
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Description
Chemical name: 11-(4-dimethylamino-3-hydroxy-6-methyl-oxan-2-yl)oxy-2-ethyl-3, 4, 10-tr; 1-Oxa-6-azacyclopentadecan-15-one, 13-((2, 6-dideoxy-3-C-methyl-1-3-O-methyl-alpha-L-ribo-hexopyranosyl)-oxy)-2-ethyl-3, 4, 10-trihydroxy-3, 5, 6, 8, 10, 12, 14-heptamethyl-11-((3, 4, 6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl)oxy); .
Molecular formula: C38H72N2O12
Quality standard: USP26/30/34, CP2010
Appearance: White or off-white crystalline powder.
Assay: Not less than 945 Azithromycin unit/1mg (anhydrous).
Application: It is clinically used in the therapy of infections of respiratory tract, skin and soft tissue caused by microorganisms.
Storage: Sealed tightly, kept in cool and dry place.
Valid period: 2 years
Molecular formula: C38H72N2O12
Quality standard: USP26/30/34, CP2010
Appearance: White or off-white crystalline powder.
Assay: Not less than 945 Azithromycin unit/1mg (anhydrous).
Application: It is clinically used in the therapy of infections of respiratory tract, skin and soft tissue caused by microorganisms.
Storage: Sealed tightly, kept in cool and dry place.
Valid period: 2 years
Product Name | Azithromycin dihydrate |
Specification | 25kg/drum | ||
Batch No. | 101205 | Batch Quantity | 100kg | ||
Manu. Date | 2010.12.08 | Report Date | 2010.12.10 | ||
Expiry Date | 2012.11 | Testing Basis | USP30 | ||
Items | Requirements | Results | |||
Description | A white or almost white powder | Complies | |||
Solubility | Practically insoluble in water, freely solube in ethanol and in methylene chloride | Complies | |||
Identification | |||||
IP spectrum | Conforms to azithromycin RS | Complies | |||
Rt HPLC | Conforms to azithromycin RS | Complies | |||
Tests | |||||
pH | 9.0~11.0 | 9.6 | |||
Specific rotation | -45° ~ -49° | -47.8° | |||
Crystallinity | Meets the requirement | Meets the requirement | |||
Limit of related substances | (1)Not more than 0.3% of desosaminy lazithromycin, 0.7% of N-demethyl azithromycin | Complies | |||
(2)any other individual related substance is not more than 1.0% | Complies | ||||
(3)the sum of all related substances is not more than 3.0% | Complies | ||||
Water | 4.0%~5.0% | 4.5% | |||
Loss on drying | 4.0%~6.5% | 5.4% | |||
Residue on ignition | Not more than 0.3% | complies | |||
Heavy metals | Not more than 25ppm | complies | |||
Assay | 945μ g/mg~1030μ g/mg | 975μ g/mg | |||
Conclusion | The above product conforms to USP30 |
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Azithromycin Dihyrate (CAS: 83905-01-5)
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