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Dexmedetomidine Hydrochloride Injection CAS 145108-58-3

Molecular Formula: C13H17ClN2

Formula Weight: 236.74

ZSpharmac: Dexmedetomidine Hydrochloride Injection Supplement

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Product Name: Dexmedetomidine Hydrochloride Injection
CAS No: 145108-58-3
Purity: 99%

Basic Info

Product Name:Dexmedetomidine Hydrochloride Injection
Other Names:Dexmedetomidine HCl
CAS:145108-58-3
Place of Origin:Shandong, China
Brand Name:ZSpharmac
Type:Pharmaceutical Raw Materials
Appearance:White to Beige Powder
EINECS No.:262-390-0
Storage:2-8°C
Provide:Dexmedetomidine Hydrochloride Injection MSDS;
Dexmedetomidine Hydrochloride Injection COA

What is Dexmedetomidine Hydrochloride Injection?

Dexmedetomidine hydrochloride is a highly selective adrenergic receptor agonist, mainly used for sedation during endotracheal intubation and mechanical ventilation in surgical patients undergoing general anesthesia, as well as intubation and ventilator patients during intensive care treatment of sedation. Dexmedetomidine hydrochloride is the only sedative drug that can be awakened during surgery. It has certain anti-anxiety, analgesic and diuretic effects. It has the advantages of less respiratory depression, low incidence of delirium, and protection of organs such as the heart/kidney/brain. It has been approved by “Chinese Adult ICU Analgesia and Sedation Treatment Guidelines (2018)”, “Expert Consensus on the Application of Dexmedetomidine in Cardiovascular Anesthesia and Perioperative Period (20Chemicalbook18)”, “Clinical Practice Guidelines: Adult Patients in ICU” Management of pain, agitation/sedation, delirium, immobilization and sleep disruption (2018)” and other authoritative guidelines and expert consensus at home and abroad are widely recommendedDexmedetomidine hydrochloride injection is a product of the 2020 version of the National Medical Insurance Catalogue, with sales of 3.60 billion yuan in China in 2019. At present, three new anesthetic and analgesic products, parecoxib sodium for injection, dexmedetomidine hydrochloride injection, and propofol medium/long-chain fat emulsion injection, have been approved, and preliminary product clusters have been formed in this field. .

Dexmedetomidine Hydrochloride Injection Properties:

Melting point 156.5-157.5°
alpha +52.4° (c = 1 in water)
density 1.17 g/cm3
storage temp. 2-8°C
solubility H2O: soluble20mg/mL, clear
form powder
color white to beige

 

Dexmedetomidine Hydrochloride Injection Uses

  1. Dexmedetomidine hydrochloride is used for pain relief, sedation, ease of surgery and mechanical ventilation. The incidence of bradycardia is high, and sedation is more frequent, which affects its widespread use.

Application and Clinical Application of Dexmedetomidine Hydrochloride

Dexmedetomidine hydrochloride (dexmedetomidine) is a new type of highly selective α2 receptor agonist, which is widely used in intensive care unit (ICU) and clinical anesthesia due to its unique pharmacological characteristics. Dexmedetomidine has sedative and anti-anxiety effects, in addition to analgesia, anti-sympathetic inhibition of perioperative stress response, reduction of the dosage of anesthetics, and maintenance of hemodynamic stability.
Preoperative medication: Dexmedetomidine can effectively relieve the invasive operation before anesthesia and the nervousness of patients, and at the same time effectively inhibit the fluctuation of hemodynamics caused by endotracheal intubation and surgical stress. Appropriate doses can be given intravenously according to body weight to relieve tension and anxiety in patients. Some studies have confirmed that dexmedetomidine has better sedative effect than oral midazolam.

Clinical application:

1. Application in neurosurgery:
Dexmedetomidine plays an important role in neurosurgery, by providing stable cerebral hemodynamics, suppressing elevated intracranial pressure during tracheal intubation, maintaining patient comfort during sedation, and providing neurocognitive and It is easy to wake up during motor function tests. In neurosurgery, dexmedetomidine did not increase the incidence of hypotension and bradycardia.
2. Application in cardiac surgery:
Stress response is an important factor in perioperative cardiovascular complications, dexmedetomidine
It can effectively reduce perioperative cardiovascular complications such as myocardial infarction in cardiac surgery patients by controlling the stress response, and at the same time, its protective effect on the myocardium, maintaining the balance of myocardial oxygen supply and demand, and anti-arrhythmic effect.
3. Postoperative adjuvant medication and analgesia:
Dexmedetomidine has a certain preventive effect on postoperative chills, irritability, nausea and vomiting in patients, thereby reducing the need for postoperative oxygen metabolism, which is especially important for patients with heart disease. For patients with insufficient analgesia, continuous postoperative infusion can improve the patient-controlled analgesia (PCA) effect of morphine patients, while reducing the amount of morphine use and the dose-related side effects.
4. Application in pediatric surgery:
Dexmedetomidine has been used as a preoperative drug in children to allow better compliance
Sex and separation from parents. It can reduce the risk of ventricular and supraventricular tachycardia in children after congenital heart disease. The child is quieter and easier to wake up after surgery.

Preparation of Dexmedetomidine Hydrochloride

1) Preparation of medetomidine
Into the 20L dry glass reaction kettle, add 1.86kg of trimethylsilimidazole and 9.85L of dichloromethane in turn, stir for 10min, start to add 2.52kg of titanium tetrachloride dropwise, control the internal temperature to 20~30℃, and continue stirring 30min, continue to add 1.33kg of 1-(2,3-dimethylbenzene) ethanol dropwise under the temperature adjustment, after the drop is completed, continue to stir the reaction for 18h, take samples for TLC detection or HPLC detection. After the completion of the reaction, the reaction solution was added to 10L of ice water, stirred for 20min, left to stand for stratification, the aqueous phase and the organic phase were separated, the organic phase was discarded, the pH of the aqueous phase was adjusted to 10 with sodium hydroxide, and 12L of dichloromethane was added for extraction. , separate the organic phase, add 4L of dichloromethane to the aqueous phase again for extraction, and combine the organic phases. The organic phase was dried with anhydrous sodium sulfate, filtered, and the filtrate was concentrated to dryness under reduced pressure to obtain 2.23 kg of a yellow oily liquid, which was a crude product of medetomidine, with a yield of 89.9%.
2) Refinement of medetomidine
In the 30L dry glass reaction kettle, add 2.23kg of medetomidine crude product successively, 22.3L of dehydrated alcohol and 0.65kg of L-(+) tartaric acid, stir and heat up to make the solids dissolve completely, turn off the heating, naturally cool down and stir, and crystallize 10h, filter, collect the solid, add the obtained white solid to 22.3L of dichloromethane and 5.6L of water, stir, add sodium hydroxide, adjust the pH to pH 10, stir for 15min, stand for stratification, separate the organic phase, add no The water was dried over sodium sulfate, filtered, and the filtrate was concentrated to dryness under reduced pressure to obtain 1.56 kg of yellow oily liquid, which was a refined product of medetomidine, and the yield was 70.0%.
3) Preparation of Dexmedetomidine
In the 50L dry glass reactor, add 1.56kg of refined medetomidine, 31.8L of dehydrated alcohol and 0.42kg of L-(+) tartaric acid successively, stir and heat up to make the solids dissolve completely, turn off the heating, and naturally cool down to room temperature , crystallized for 10h, filtered, and the solid was collected. The obtained white solid was added to 31.8L of dichloromethane and 10.6L of water, stirred, added with sodium hydroxide, adjusted to pH 10, stirred for 15min, left to stand for stratification, and the organic phase was separated. , was dried by adding anhydrous sodium sulfate, filtered, and the filtrate was concentrated to dryness under reduced pressure to obtain 0.47kg of white solid, which was dexmedetomidine.
4) Preparation of Dexmedetomidine Hydrochloride
0.47kg of dexmedetomidine was added to 9.4L of dichloromethane, stirred to dissolve all the solids, and after the solution was clear, 390ml of 9N hydrochloric acid ethanol was added dropwise. 37.6L of petroleum ether was added dropwise, and a large amount of white solid was precipitated. After the drop was completed, stirring and crystallization was carried out for 2 h, suction filtration, and the filter cake was blast-dried to constant weight to obtain 0.54 kg of dexmedetomidine hydrochloride, with a total yield of 18.4 %.

Company Profile and Company Culture

ZhiShang Chemical is owned by ZhiShang Group is a professional new-type chemicals enterprise combined into research and development, production and sales .

The company’s competitive product is pharmaceutical raw materials and intermediates (especially carbohydrate derivatives Series), In recent years, the company has made a major breakthrough in food and feed additives, plant extraction, industrial chemicals industry .

The company insists on the spirit of “sincere management, strict quality control, customer as god” , get consistent high praise from customers at home and abroad.

OUR MISSION

Help China Chemicals to benefit the happiness of human life

OUR VISION

Become the most trusted chemical supplier in the world

OUR BUSINESS PHILOSOPHY

Striver – oriented, enrich employees, customer first, deep service, seek development

OUR VALUES

Be prepared for danger in times of peace, forge ahead actively, unity and cooperation, and be brave to fight

About Us

The production base is located in Zhangqiu chemical industry park and Tai’an high-tech chemical industry park. laboratory and workshop in strict accordance with the GMP standard and the product fit national ISO9001 and ISO2000 standards.

“Zhishang” products are exported to Europe, North and South America, the Middle East, Asia Pacific and Africa area, so as to establish a long-term and stable cooperation relationship with customer in the world.

Company Info
  • Business Type: Manufacturer
  • Product Range: Additive , Chemical Auxiliary & Catalyst , Organic Chemicals
  • Products/Service: Organic Intermediate,Inorganic Chemistry, APIs, Dyestuffs And Pigments, Fragrance And Spices, Food Additives
  • Total Employees: 51~100
  • Capital (Million US $): 10000000RMB
  • Year Established: 2016
Production Capacity
  • No. of Production Lines : 8
  • No. of QC Staff : 5 -10 People
  • OEM Services Provided : yes
  • Factory Size (Sq.meters) : 3,000-5,000 square meters
  • Certificate: ISO9001 , CE , GMP , API , MSDS
  • Factory Location : Diao Town Industry Park, Zhangqiu City, Jinan City, Shandong Province, China.

Service

Pre-Sales Service

* Prompt reply and 24 hours online, professional team to provide best price and high quality product.

* Sample testing support.

* Every batch of products will be tested to ensureits quality.

*The packing also can be according the customers` requirment.

*Any inquiries will be replied within 24 hours.

*we provide Commerical Invoice, Packing List, Bill of loading, COA , Health certificate and Origin certificate. If your markets have any special requirements, let us know.

 

After-Sales Service

*The fact of logistics information monitoring.

* Any questions about the product can be consulted at any time.

*Product has any problem can return.

FAQ

Do you accept sample order?

We will make samples before mass production, and after sample approved, we’ll begin mass production. Doing 100% inspection during production, then do random inspection before packing.

 

HOW TO CONFIRM THE PRODUCT QUALITY BEFORE PLACING ORDERS?

You can get free samples for some products,you only need to pay the shipping cost or arrange a courier to us and take the samples. You can send us your product specifications and requests,we will manufacture the products according to your requests.

What’s your MOQ?

Our MOQ is 1kg. But usually we accept less quantity such as 100g on the condition that sample charge is 100% paid.

Do you supply product report?

Yes. We’ll give you product analysis report before shipping.

  Is there a discount?

Different quantity has different discount.

Shipping

1. ≤50kg, Express delivery recommended, usually called as DDU service;

2. ≤500kg, Air shipping recommended, usually called as FOB, CFR, or CIF service;

3. >500kg, sea shipping recommended, usually called as FOB, CFR, or CIF service;

4. For high value products, please select air shipping and express delivery for safe.

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