Dexmedetomidine Hydrochloride CAS No 145108 -58-3

China Dexmedetomidine Hydrochloride CAS No 145108-58-3, Find details about China Dexmedetomidine, 145108-58-3 from Dexmedetomidine Hydrochloride CAS No 145108-58-3

Basic Info.

Model NO.

SAMREAL-0354

Trademark

samreal

Specification

25kg/drum

Origin

China

Model NO.

SAMREAL-0354

Trademark

samreal

Specification

25kg/drum

Origin

China

Product Desciption

Dexmedetomidine hydrochloride cas no 145108-58-3

Tests Carried Out	Limits	Observations
Characteristics	White or off-white crystalline powder;Hygroscopic	white crystalline powder;Hygroscopic
Melting point	154ºC~158ºC	156ºC~156ºC
Specific optical rotation	+51.5°~+54.5°	+52.3°
Identification	In the chromatogram recorded under isomer test,the retention time of major peak in test solution should correspond to that of dexmedetomidine peak in system suitability solution	Conforms
	Maximum absorption at 263nm,minimum absorption at 243nm	Conforms
	The infrared absorption spectrum of this product should be consistent with that of the reference substance	Conforms
	It gives reaction of chloride.	Conforms
The clarity and color of the solution	The solution should be clear and colorless;if the color is developed,it should be not more intensely than the yellow standard colorimetric solution 1	Conforms
PH	3.8~4.8	4.2
Relevant substances	Impurity YM-Z1 should be NMT 0.1%	Not detected
	Impurity YM-1 should be NMT 0.1%	<0.04%
	Impurity YM-Z3 should be NMT 0.1%	Not detected
	Impurity YM-Z5 should be NMT 0.1%	<0.04%
	Individual unspecified impurity should be NMT 0.10%	<0.04%
	Total impurities should be NMT 0.3%	<0.04%
Isomer	NMT 0.15%	0.09%
Residual solvents	Chloroethane should be NMT 0.1%	0.0003%
	Ethyl ether should be NMT 0.5%	0.03%
	Dichloromethane should be NMT 0.06%	0.007%
Dimethyl sulfoxide	NMT 0.5%	0.02%
Water	NMT 1.5%	1.0%
Residue on ignition	NMT 0.1%	0.01%
Heavy metals	NMT 10ppm	Conforms
Tartrate	No turbidity	Conforms
Chlorinity	14.2%~15.7%	15.5%
Bacterial endotoxins	NMT 10EU/mg	Conforms
Microbial Limit	TAMC:NMT 10³ cfu/g	<10cfu/g
Microbial Limit	TYMC:NMT 10² cfu/g	<10cfu/g

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Dexmedetomidine Hydrochloride CAS No 145108-58-3

Dexmedetomidine Hydrochloride CAS No 145108-58-3

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