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    Chemistry

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    Also known as: Midazolam hcl, 59467-96-8, Versed, Hypnovel, Midazolam hydrochloride [usan], Ro 21-3981/003
    Molecular Formula
    C18H14Cl2FN3
    Molecular Weight
    362.2  g/mol
    InChI Key
    PLYSCVSCYOQVRP-UHFFFAOYSA-N
    FDA UNII
    W7TTW573JJ
    Midazolam Hydrochloride
    A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.
    1 2D Structure

    Midazolam Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine;hydrochloride
    2.1.2 InChI
    InChI=1S/C18H13ClFN3.ClH/c1-11-21-9-13-10-22-18(14-4-2-3-5-16(14)20)15-8-12(19)6-7-17(15)23(11)13;/h2-9H,10H2,1H3;1H
    2.1.3 InChI Key
    PLYSCVSCYOQVRP-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=NC=C2N1C3=C(C=C(C=C3)Cl)C(=NC2)C4=CC=CC=C4F.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    W7TTW573JJ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Dormicum

    2. Hydrochloride, Midazolam

    3. Maleate, Midazolam

    4. Midazolam

    5. Midazolam Maleate

    6. Ro 21 3981

    7. Ro 21-3981

    8. Ro 213981

    9. Versed

    2.3.2 Depositor-Supplied Synonyms

    1. Midazolam Hcl

    2. 59467-96-8

    3. Versed

    4. Hypnovel

    5. Midazolam Hydrochloride [usan]

    6. Ro 21-3981/003

    7. Buccolam

    8. Midazolam Hydrochloride Civ

    9. Nsc-751451

    10. W7ttw573jj

    11. Shp615

    12. Shp-615

    13. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo[1,5-a][1,4]benzodiazepine Hydrochloride

    14. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo[1,5-a][1,4]benzodiazepine;hydrochloride

    15. Rocam

    16. Ro-213981001

    17. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo(1,5-a)(1,4)benzodiazepine Hydrochloride

    18. Dsstox_cid_27824

    19. Dsstox_rid_82587

    20. Dsstox_gsid_47846

    21. Midazolam Hydrochloride (usan)

    22. Cas-59467-96-8

    23. Ncgc00168254-01

    24. Einecs 261-776-6

    25. Unii-w7ttw573jj

    26. Ro-21-3981/003

    27. Versed Hydrochloride

    28. Versed (tn)

    29. Seizalam

    30. Hypnovel Hydrochloride

    31. Midazolam Hydrochloride Preservative Free

    32. Midazolam (hydrochloride)

    33. Schembl41265

    34. Mls001401415

    35. Chebi:6932

    36. Chembl1200420

    37. Dtxsid8047846

    38. Hy-b0676a

    39. Bcp15579

    40. Midazolam Hydrochloride [mi]

    41. Tox21_112613

    42. Nsc751451

    43. Midazolam Hydrochloride [hsdb]

    44. Akos024457308

    45. Tox21_112613_1

    46. Ccg-100983

    47. Midazolam Hydrochloride [mart.]

    48. Midazolam Hydrochloride [vandf]

    49. Nc00233

    50. Nsc 751451

    51. 4h-imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, Hydrochloride

    52. 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo(1,5-a)(1,4)benzodiazepine Monohydrochloride

    53. 8-chloro-6-(o-fluorophenyl)-1-methyl-4h-imidazo(1,5-a)(1,4)benzodiazepine Monohydrochloride

    54. Midazolam Hydrochloride [who-dd]

    55. Ncgc00168254-02

    56. 4h-imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, Monohydrochloride

    57. Smr000469160

    58. Midazolam Hydrochloride [orange Book]

    59. Midazolam Hydrochloride Civ [usp-rs]

    60. D00696

    61. 467m968

    62. Q27292444

    63. 4h-imidazo[1,5a][1,4]benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, Hydrochloride

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 362.2 g/mol
    Molecular Formula C18H14Cl2FN3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count1
    Exact Mass361.0548810 g/mol
    Monoisotopic Mass361.0548810 g/mol
    Topological Polar Surface Area30.2 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity471
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 NameMidazolam hydrochloride
    Drug LabelMidazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam USP compou...
    Active IngredientMidazolam hydrochloride
    Dosage FormSyrup; Injectable
    RouteInjection; Oral
    Strengtheq 2mg base/ml; eq 1mg base/ml; eq 5mg base/ml
    Market StatusPrescription
    CompanyWockhardt; Ranbaxy; Bedford; Hospira; Gland Pharma; Roxane; Hi Tech Pharma; Paddock; Fresenius Kabi Usa; Hikma Maple; Bedford Labs; Akorn

    2 of 4  
    Drug NameMidazolam hydrochloride preservative free
    Active IngredientMidazolam hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 1mg base/ml; eq 5mg base/ml
    Market StatusPrescription
    CompanySagent Strides; Hospira; Bd Rx

    3 of 4  
    Drug NameMidazolam hydrochloride
    Drug LabelMidazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam USP compou...
    Active IngredientMidazolam hydrochloride
    Dosage FormSyrup; Injectable
    RouteInjection; Oral
    Strengtheq 2mg base/ml; eq 1mg base/ml; eq 5mg base/ml
    Market StatusPrescription
    CompanyWockhardt; Ranbaxy; Bedford; Hospira; Gland Pharma; Roxane; Hi Tech Pharma; Paddock; Fresenius Kabi Usa; Hikma Maple; Bedford Labs; Akorn

    4 of 4  
    Drug NameMidazolam hydrochloride preservative free
    Active IngredientMidazolam hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 1mg base/ml; eq 5mg base/ml
    Market StatusPrescription
    CompanySagent Strides; Hospira; Bd Rx

    4.2 Drug Indication

    Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).

    Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.

    For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.

    Epileptic seizures

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Adjuvants, Anesthesia

    Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

    Anesthetics, Intravenous

    Ultrashort-acting anesthetics that are used for induction. Loss of consciousness is rapid and induction is pleasant, but there is no muscle relaxation and reflexes frequently are not reduced adequately. Repeated administration results in accumulation and prolongs the recovery time. Since these agents have little if any analgesic activity, they are seldom used alone except in brief minor procedures. (From AMA Drug Evaluations Annual, 1994, p174) (See all compounds classified as Anesthetics, Intravenous.)

    GABA Modulators

    Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)

    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.)

    Anti-Anxiety Agents

    Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Benzodiazepines [CS]; Benzodiazepine [EPC]
    5.3 ATC Code

    N05CD08

    API Reference Price

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    13-Oct-2021
    16-Dec-2024
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    ABOUT THIS PAGE

    Midazolam Hydrochloride Manufacturers

    A Midazolam Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midazolam Hydrochloride, including repackagers and relabelers. The FDA regulates Midazolam Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midazolam 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 Midazolam Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Midazolam Hydrochloride Suppliers

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

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

    Midazolam Hydrochloride USDMF

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

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

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

    Midazolam Hydrochloride WC

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

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

    Midazolam 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 Midazolam Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Midazolam 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 Midazolam 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 Midazolam Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Midazolam Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

    Midazolam Hydrochloride GMP

    Midazolam 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 Midazolam 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 Midazolam Hydrochloride GMP manufacturer or Midazolam Hydrochloride GMP API supplier for your needs.

    Midazolam Hydrochloride CoA

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

    Midazolam Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Midazolam 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.

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