Platinum Member, 9 year(s)
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Bangladesh  Uttara , Uttara

Azelastine Hydrochloride


Azelastine hydrochloride (HCl), fluticasone propionate 137mcg/50mcg; per 0.137mL metered nasal spray; aqueous suspension.<br /> <br /> Definition<br /> <br /> Azelastine Hydrochloride is (RS)-4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one hydrochloride. It contains not less than 98.5% and not more than 101.0% of C22H24ClN3O, HCl, calculated with reference to the dried substance.<br /> <br /> Characteristics<br /> <br /> A white, crystalline powder.<br /> <br /> Slightly soluble in water ; soluble in absolute ethanol ; practically insoluble in ether , in n-hexane and in toluene.<br /> <br /> Identification<br /> <br /> A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of azelastine hydrochloride(RS 018).<br /> <br /> B. Yields reaction A characteristic of chlorides, Appendix VI.<br /> <br /> C. Complies with the test for Optical rotation.




Expected Price TZS Per Pack
Delivery Terms 2 Week
Shipping 55000 Kilogram / Year
Shipping Point 19


Category Name Pharmaceutical Chemicals
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Name of Product Azelastine Hydrochloride
Buying Offer ID 53
Offer remain valid until 2017-01-14 09:00:00
Expected Quantity 2500 Per Pack
Packaging kg/cardboard drum, 10 kg/cardboard drum
Method of Payment T/T,L/C,D/A,D/P,Western Union,Money Gram,PayPal,Other
Product Specifications MF : C22H24ClN3O·HCl , Type : Anti-Allergic Agents, Grade Standard : Medicine Grade, Brand Name : Elbine, Purity (%) : 99.0
Shipping Terms CAT
Brand Name Dymista
Model/Article Number EL-TOP-54
Manufacturers Elbine-HT
Place of Origin Malaysia
Colour Water
Materials/Ingredients azelastine hydrochloride and fluticasone propionate


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Carry out the method for thin-layer chromatography, Appendix III A, using TLC silica gel F254 plate (Merck silica gel 60 F254plates are suitable) and a mixture of 1 volume of 18M ammonia, 40 volumes of ethanol (96%) and 60 volumes of toluene as the mobile phase. Apply separately to the plate 10 µl of each of four solutions in a mixture of equal volumes of dichloromethaneand methanol containing (1) 5.0% w/v and (2) 0.0050% w/v of the substance being examined, (3) 0.0050% w/v of 4-chlorobenzylphthalazinone BPCRS and (4) 0.0050% w/v of 1-methylazepan-4-one hydrochloride BPCRS. After removal of the plate, heat at 115 for 1 hour, cool and examine under ultraviolet light (254 nm). Spray the plate with sodium iodobismuthate solution followed by a 5% w/v solution of sodium nitrite and re-examine. In the chromatogram obtained with solution (1) any spot corresponding to either of the two named impurities is not more intense than the corresponding spot in the chromatograms obtained with solution (3) and (4), respectively (0.1% of each) and any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.1%). Disregard any spot remaining on the line of application.

Loss on drying

When dried to constant weight at 100 to 105 loses not more than 1% of its weight. Use 1 g.

Assay

Dissolve 0.3 g in 5 ml of anhydrous formic acid, add 30 ml of acetic anhydride and carry out Method I for non-aqueous titration, Appendix VIII A, determining the end-point potentiometrically. Each ml of 0.1M perchloric acid VS is equivalent to 41.84 mg of C22H24ClN3O, HCl.

Storage

Azelastine Hydrochloride should be kept in an airtight container and protected from light.

Action and use

Prophylaxis of allergic conditions.

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  • Mr. Jamil Uddin

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  • Bangladesh   Uttara , Uttara
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