Dexmedetomidine hydrochloride CAS 145108-58-3

  • Product Name:Dexmedetomidine hydrochloride
  • CAS:145108-58-3
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Dexmedetomidine hydrochloride CAS 145108-58-3

Dexmedetomidine hydrochloride CAS 145108-58-3 Basic information

Product Name: Dexmedetomidine hydrochloride
Synonyms: 4-[(1r)-1-(2,3-dimethylphenyl)ethyl]-3h-imidazole hydrochloride;4-((s)-alpha,2,3-trimethylbenzyl)imidazole monohydrochloride;DEXMEDETOMIDINE HCL;DEXMEDETOMIDINE HYDROCHLORIDE;DEMEDETOMIDINE HCL;Dexmedetomidine(Pilot);4-[(1S)-1-(2,3-Dimethylphenyl)ethyl]-1
CAS: 145108-58-3
MF: C13H17ClN2
MW: 236.74048
EINECS: 682-047-2
Product Categories: Inhibitors;API
Mol File: 145108-58-3.mol

Dexmedetomidine hydrochloride CAS 145108-58-3 Chemical Properties

density: 1.17 g/cm3
Melting point: 156.5-157.5°
form: powder
storage temp.: Desiccate at RT
color: white to beige
solubility: H2O: soluble20mg/mL, clear
Merck: 14,2946

产品名称

Product Name

盐酸右美托咪定

Dexmedetomidine Hydrochloride

CAS No.

145108-58-3

产品批号

Batch No.

190502

生产日期

Mfg. Date

2019.05.18

报告日期

Report Date

2019.05.23

有效期至

Exp. Date

2021.05.17

数量

Quantity

0.262kg

检验依据

Quality Standard

 

USP40

检验项目

Tests

标准规定

SPECIFICATIONS

检验结果

RESULTS

外观

Appearance

白色或类白色结晶性粉末

White or off-white crystalline powder

白色结晶性粉末

White crystalline powder

 

溶解性

Solubility

本品在水中极易溶,在乙醇氯仿中易溶,在乙 醚中几乎不溶 Easily soluble in water, freely soluble in ethanol and chloroform, practically insoluble in aether

 

符合规定

Conforms

熔点

Melting point

153-158

156-157.3

鉴别

Identification

1

紫外鉴别 UV identification

符合规定 Conforms

2

红外鉴别 IR identification

符合规定 Conforms

3

氯化物鉴别 Chloride identification

符合规定 Conforms

酸度(PH

3.5-5.5

4.15

 

溶液的澄清度与颜色Clarity and Color of Solution

溶液应澄清无色,如显浑浊,与 1 号浊度标

准液比较,不得更浓;如显色,与黄色 1 号标准液比较,不得更深。

Should be clear and colorlessif turbid and coloured, not more nepheloid than turbidity-2,

not more strong than yellow-1.

 

 

符合规定 Conforms

比旋度

Specific rotation

+51.0°+54.0°

+51.28°

酸度

PH

3.55.5

4.16

 

 

有关物质

Related substances

总杂质

Total impurities 0.5%

0.030%

最大未知单一杂质

Max unknown single impurity 0.1%

0.028%

盐酸左美托咪定

Levomedetomidine HCl ≤1.0%

0.041%

干燥失重

Loss on drying

1.0%

0.108%

炽灼残渣

Residue on ignition

0.1%

0.065%

重金属

Heavy metal

≤20ppm

符合规定

Conforms

 

残留溶剂

Residual solvent

四氢呋喃 Tetrahydrofuran0.072

N.D.

二氯甲烷 Dichloromethane0.4

N.D.

甲醇 Methanol0.3

N.D.

乙醇 Ethanol0.5

N.D

乙酸乙酯 Ethyl acetate0.5%

0.042%

含量

Assay

98.0%102%

99.90%

结论

Conclusion

本品按 USP40 检验,结果符合规定。

The results conform to the USP40 standard

Dexmedetomidine hydrochloride Usage And Synthesis
DescriptionDexmedetomidine was launched in the US as an i.v. infusion for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care unit, This imidazole derivative is the (S)-enantiomer of medetomidine that can be obtained via fractional crystallization of the tartrate salt of the racemic mixture. Dexmedetomidine is a full agonist of α2 adrenoceptors with 1300-fold selectivity versus α1 compared to the less selective partial α2 agonist clonidine, a veterinary hypnotic. Dexmedetomidine is unique compared with currently available sedatives in that it provides sedation, analgesia and anxiolysis with the ability of patients to be easily awakened. Besides, it causes minimal respiratory depression unlike other available drugs such as benzodiazepines or opioids. Pharmacological studies in transgenic mice showed that the sedative, anesthetic and analgesic effects of dexmedetomidine are specifically due to the stimulation of the a2A subtype receptor. Like other α2 adrenoceptor agonists, dexmedetomidine can provoke hypotension and bradycardia probably because of its non-selective action on peripheral a2B subtype receptors in vascular smooth muscle. Dexmedetomidine is extensively metabolized into methyl and glucuronide conjugates which are mainly eliminated by renal excretion. It was found to be a CYP2D6 inhibitor but less potent than the clinically relevant standard quinidine.
OriginatorOrion (Finland)
Useshighly selective, potent α2-adrenoceptor agonist, analgesic, anxiolytic, bradycardic, hypotensive, sedative, hypothermic


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