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Chemistry

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Also known as: 145108-58-3, Dexmedetomidine hcl, Precedex, Dexdomitor, Dexdor, Sileo
Molecular Formula
C13H17ClN2
Molecular Weight
236.74  g/mol
InChI Key
VPNGEIHDPSLNMU-MERQFXBCSA-N
FDA UNII
1018WH7F9I

Dexmedetomidine Hydrochloride
A imidazole derivative that is an agonist of ADRENERGIC ALPHA-2 RECEPTORS. It is closely-related to MEDETOMIDINE, which is the racemic form of this compound.
1 2D Structure

Dexmedetomidine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole;hydrochloride
2.1.2 InChI
InChI=1S/C13H16N2.ClH/c1-9-5-4-6-12(10(9)2)11(3)13-7-14-8-15-13;/h4-8,11H,1-3H3,(H,14,15);1H/t11-;/m0./s1
2.1.3 InChI Key
VPNGEIHDPSLNMU-MERQFXBCSA-N
2.1.4 Canonical SMILES
CC1=C(C(=CC=C1)C(C)C2=CN=CN2)C.Cl
2.1.5 Isomeric SMILES
CC1=C(C(=CC=C1)[C@H](C)C2=CN=CN2)C.Cl
2.2 Other Identifiers
2.2.1 UNII
1018WH7F9I
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dexmedetomidine

2. Hydrochloride, Dexmedetomidine

3. Mpv 1440

4. Mpv-1440

5. Mpv1440

6. Precedex

2.3.2 Depositor-Supplied Synonyms

1. 145108-58-3

2. Dexmedetomidine Hcl

3. Precedex

4. Dexdomitor

5. Dexdor

6. Sileo

7. Dexmedetomidine (hydrochloride)

8. Cepedex

9. Sedadex

10. (s)-5-(1-(2,3-dimethylphenyl)ethyl)-1h-imidazole Hydrochloride

11. (+)-medetomidine Hydrochloride

12. Dexmedetomidine Hcl (precedex)

13. Dexmedetomidine Hydrochloride [usan]

14. 4-((s)-alpha,2,3-trimethylbenzyl)imidazole Monohydrochloride

15. D-medetomidine Hydrochloride

16. Chebi:31472

17. 1018wh7f9i

18. Precedex (tn)

19. (s)-4-(1-(2,3-dimethylphenyl)ethyl)-1h-imidazole Hydrochloride

20. 4-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole Hydrochloride

21. 5-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole;hydrochloride

22. 145108-58-3 (hcl)

23. 1h-imidazole, 4-[(1s)-1-(2,3-dimethylphenyl)ethyl]-, Monohydrochloride

24. 1h-imidazole, 4-(1-(2,3-dimethylphenyl)ethyl)-, Monohydrochloride, (s)-

25. 1h-imidazole, 5-[(1s)-1-(2,3-dimethylphenyl)ethyl]-, Hydrochloride (1:1)

26. (s)-medetomidine Hydrochloride

27. Primadex

28. Unii-1018wh7f9i

29. (s)-4-[1-(2,3-dimethylphenyl)ethyl]-1h-imidazole Hydrochloride

30. 4-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole;hydrochloride

31. Dexmedetomidinehcl

32. Igalmi

33. Mls006011569

34. Schembl406837

35. Chembl2106195

36. Dtxsid40873215

37. Dexmedetomidine Hcl [vandf]

38. Act04745

39. 5-[(1s)-1-(2,3-dimethylphenyl)ethyl]-1h-imidazole Hydrochloride

40. Ac-310

41. Hy-17034a

42. Mfcd22683223

43. S2090

44. Akos024457275

45. Akos025402024

46. Bcp9000600

47. Ccg-266849

48. H08d583

49. Dexmedetomidine Hydrochloride (jan/usp)

50. As-12485

51. Dexmedetomidine Hydrochloride [mi]

52. Smr004703327

53. Bcp0726000002

54. Dexmedetomidine Hydrochloride [jan]

55. Am20080946

56. D5062

57. Dexmedetomidine Hydrochloride [mart.]

58. Sw219607-2

59. 4-((s)-a,2,3-trimethylbenzyl)imidazole Hcl

60. Dexmedetomidine Hydrochloride [usp-rs]

61. Dexmedetomidine Hydrochloride [who-dd]

62. D01205

63. Dexmedetomidine Hydrochloride [ema Epar]

64. A808325

65. Dexmedetomidine Hydrochloride [green Book]

66. Dexmedetomidine Hydrochloride [orange Book]

67. Dexmedetomidine Hydrochloride [usp Monograph]

68. Q-100166

69. Q27114321

70. Z1617901127

71. Dexmedetomidine Hydrochloride (ema Epar: Veterinary)

72. (+)-medetomidine Hydrochloride;(s)-medetomidine Hydrochloride

73. (s)-4-(alpha,2,3-trimethybenzyl)-1h-imidazole Hydrochloride

74. (s)-5-(1-(2,3-dimethylphenyl)ethyl)-1h-imidazolehydrochloride

75. 4-((s)-.alpha.,2,3-trimethylbenzyl)imidazole Monohydrochloride

2.4 Create Date
2006-07-28
3 Chemical and Physical Properties
Molecular Weight 236.74 g/mol
Molecular Formula C13H17ClN2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count1
Rotatable Bond Count2
Exact Mass236.1080262 g/mol
Monoisotopic Mass236.1080262 g/mol
Topological Polar Surface Area28.7 Ų
Heavy Atom Count16
Formal Charge0
Complexity205
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameDexmedetomidine hydrochloride
PubMed HealthDexmedetomidine (Injection)
Drug ClassesAnalgesic, Anesthetic Adjunct, Sedative
Drug LabelDexmedetomidine hydrochloride injection concentrate is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[...
Active IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
Routeinjection; Injection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg
Market StatusTentative Approval; Prescription
CompanyPar Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn

2 of 4  
Drug NamePrecedex
Drug LabelPrecedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready t...
Active IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml)
Market StatusPrescription
CompanyHospira

3 of 4  
Drug NameDexmedetomidine hydrochloride
PubMed HealthDexmedetomidine (Injection)
Drug ClassesAnalgesic, Anesthetic Adjunct, Sedative
Drug LabelDexmedetomidine hydrochloride injection concentrate is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[...
Active IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
Routeinjection; Injection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); 100mcg (base) /ml; 100mcg
Market StatusTentative Approval; Prescription
CompanyPar Sterile Products; Caraco; Mylan Institutional; Sandoz; Akorn

4 of 4  
Drug NamePrecedex
Drug LabelPrecedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready t...
Active IngredientDexmedetomidine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 200mcg base/2ml (eq 100mcg base/ml); eq 200mcg base/50ml (eq 4mcg base/ml); eq 400mcg base/100ml (eq 4mcg base/ml)
Market StatusPrescription
CompanyHospira

4.2 Drug Indication

For sedation of adult intensive care unit patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).


Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs and cats before induction and maintenance of general anaesthesia.


Alleviation of acute anxiety and fear associated with noise in dogs.


Noninvasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Premedication in cats before induction and maintenance of general anaesthesia with ketamine.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs before induction and maintenance of general anaesthesia.


Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before induction and maintenance of general anaesthesia.


Treatment of bipolar disorder, Treatment of schizophrenia


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Adrenergic alpha-2 Receptor Agonists

Compounds that bind to and activate ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Agonists.)


Analgesics, Non-Narcotic

A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS. (See all compounds classified as Analgesics, Non-Narcotic.)


Hypnotics and Sedatives

Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Central alpha-2 Adrenergic Agonist [EPC]; General Anesthesia [PE]; Adrenergic alpha2-Agonists [MoA]
5.3 ATC Code

N05CM18


QN05CM18


QN05CM18


QN05CM18


QN05CM18


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12-Apr-2021
16-Apr-2025
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ABOUT THIS PAGE

Looking for 145108-58-3 / Dexmedetomidine Hydrochloride API manufacturers, exporters & distributors?

Dexmedetomidine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dexmedetomidine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dexmedetomidine Hydrochloride manufacturer or Dexmedetomidine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexmedetomidine Hydrochloride manufacturer or Dexmedetomidine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Dexmedetomidine Hydrochloride API Price utilized in the formulation of products. Dexmedetomidine Hydrochloride API Price is not always fixed or binding as the Dexmedetomidine Hydrochloride Price is obtained through a variety of data sources. The Dexmedetomidine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dexmedetomidine Hydrochloride

Synonyms

145108-58-3, Dexmedetomidine hcl, Precedex, Dexdomitor, Dexdor, Sileo

Cas Number

145108-58-3

Unique Ingredient Identifier (UNII)

1018WH7F9I

About Dexmedetomidine Hydrochloride

A imidazole derivative that is an agonist of ADRENERGIC ALPHA-2 RECEPTORS. It is closely-related to MEDETOMIDINE, which is the racemic form of this compound.

Dexmedetomidine Hydrochloride Manufacturers

A Dexmedetomidine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexmedetomidine Hydrochloride, including repackagers and relabelers. The FDA regulates Dexmedetomidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexmedetomidine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Dexmedetomidine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dexmedetomidine Hydrochloride Suppliers

A Dexmedetomidine Hydrochloride supplier is an individual or a company that provides Dexmedetomidine Hydrochloride active pharmaceutical ingredient (API) or Dexmedetomidine Hydrochloride finished formulations upon request. The Dexmedetomidine Hydrochloride suppliers may include Dexmedetomidine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Dexmedetomidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Dexmedetomidine Hydrochloride USDMF

A Dexmedetomidine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexmedetomidine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dexmedetomidine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dexmedetomidine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Dexmedetomidine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dexmedetomidine Hydrochloride USDMF includes data on Dexmedetomidine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexmedetomidine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Dexmedetomidine Hydrochloride suppliers with USDMF on PharmaCompass.

Dexmedetomidine Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Dexmedetomidine Hydrochloride Drug Master File in Japan (Dexmedetomidine Hydrochloride JDMF) empowers Dexmedetomidine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Dexmedetomidine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Dexmedetomidine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Dexmedetomidine Hydrochloride suppliers with JDMF on PharmaCompass.

Dexmedetomidine Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Dexmedetomidine Hydrochloride Drug Master File in Korea (Dexmedetomidine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexmedetomidine Hydrochloride. The MFDS reviews the Dexmedetomidine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Dexmedetomidine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Dexmedetomidine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dexmedetomidine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Dexmedetomidine Hydrochloride suppliers with KDMF on PharmaCompass.

Dexmedetomidine Hydrochloride WC

A Dexmedetomidine Hydrochloride written confirmation (Dexmedetomidine Hydrochloride WC) is an official document issued by a regulatory agency to a Dexmedetomidine Hydrochloride manufacturer, verifying that the manufacturing facility of a Dexmedetomidine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexmedetomidine Hydrochloride APIs or Dexmedetomidine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexmedetomidine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Dexmedetomidine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Dexmedetomidine Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Dexmedetomidine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dexmedetomidine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Dexmedetomidine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Dexmedetomidine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexmedetomidine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Dexmedetomidine Hydrochloride suppliers with NDC on PharmaCompass.

Dexmedetomidine Hydrochloride GMP

Dexmedetomidine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Dexmedetomidine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dexmedetomidine Hydrochloride GMP manufacturer or Dexmedetomidine Hydrochloride GMP API supplier for your needs.

Dexmedetomidine Hydrochloride CoA

A Dexmedetomidine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Dexmedetomidine Hydrochloride's compliance with Dexmedetomidine Hydrochloride specifications and serves as a tool for batch-level quality control.

Dexmedetomidine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Dexmedetomidine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Dexmedetomidine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexmedetomidine Hydrochloride EP), Dexmedetomidine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexmedetomidine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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