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Bedaquiline fumarate

Product Name
Bedaquiline fumarate
CAS No.
845533-86-0
Chemical Name
Bedaquiline fumarate
Synonyms
Badaquiline Fumarate;R 403323;TMC207 fumarate;R207910 fumarate;Sirturo fumarate;Bedaquiline Fumarat;TMC-207;TMC207;TMC 207;Bedaquiline (fuMarate);Bedaquinoline fumarate;Bedaquiline Fumarate salt
CBNumber
CB92705076
Molecular Formula
C36H35BrN2O6
Formula Weight
671.59
MOL File
845533-86-0.mol
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Bedaquiline fumarate Property

storage temp. 
Inert atmosphere,Room Temperature
solubility 
DMSO : 100 mg/mL (148.90 mM; Need ultrasonic)H2O : < 0.1 mg/mL (insoluble)
form 
Powder
color 
White to off-white
InChIKey
ZLVSPMRFRHMMOY-KZDJUSSONA-N
SMILES
C(/C(=O)O)=C\C(=O)O.[C@](C1=CC=CC2C=CC=CC1=2)(O)(CCN(C)C)[C@H](C1C=CC=CC=1)C1=CC2C=C(Br)C=CC=2N=C1OC |&1:8,25,r|
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Hazard and Precautionary Statements (GHS)

Symbol(GHS)
Signal word
Warning
Hazard statements

H302Harmful if swallowed

H315Causes skin irritation

H319Causes serious eye irritation

H335May cause respiratory irritation

Precautionary statements

P261Avoid breathing dust/fume/gas/mist/vapours/spray.

P264Wash hands thoroughly after handling.

P264Wash skin thouroughly after handling.

P270Do not eat, drink or smoke when using this product.

P271Use only outdoors or in a well-ventilated area.

P280Wear protective gloves/protective clothing/eye protection/face protection.

P301+P312IF SWALLOWED: call a POISON CENTER or doctor/physician IF you feel unwell.

P302+P352IF ON SKIN: wash with plenty of soap and water.

P304+P340IF INHALED: Remove victim to fresh air and Keep at rest in a position comfortable for breathing.

P305+P351+P338IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continuerinsing.

P330Rinse mouth.

P332+P313IF SKIN irritation occurs: Get medical advice/attention.

P337+P313IF eye irritation persists: Get medical advice/attention.

P362Take off contaminated clothing and wash before reuse.

P403+P233Store in a well-ventilated place. Keep container tightly closed.

P405Store locked up.

P501Dispose of contents/container to..…

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N-Bromosuccinimide Price

ApexBio Technology
Product number
B3491
Product name
Bedaquilinefumarate
Packaging
5mg
Price
$55
Updated
2021/12/16
ChemScene
Product number
CS-2922
Product name
Bedaquilinefumarate
Purity
99.98%
Packaging
5mg
Price
$60
Updated
2021/12/16
ApexBio Technology
Product number
B3491
Product name
Bedaquilinefumarate
Packaging
10mg
Price
$75
Updated
2021/12/16
ApexBio Technology
Product number
B3491
Product name
Bedaquilinefumarate
Packaging
10mM(in 1mL DMSO)
Price
$80
Updated
2021/12/16
ChemScene
Product number
CS-2922
Product name
Bedaquilinefumarate
Purity
99.98%
Packaging
10mg
Price
$90
Updated
2021/12/16
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Bedaquiline fumarate Chemical Properties,Usage,Production

Description

Bedaquiline fumarate (BQF) is an FDA-approved antituberculosis drug that targets the enzyme ATP synthase. It is a fumarate salt prepared from equimolar amounts of bedaquiline and fumaric acid. It can be used in combination therapy for the treatment of multidrug-resistant tuberculosis in the lungs of adults (18 years of age and older). The new BQF microemulsion dosage form of BQF has improved oral bioavailability over the previous formulation, and the BQF microemulsion is cytocompatible with significantly higher cellular uptake than the control group at the highest concentration of 500 μg/ml, which could lead to further use in the effective treatment of multidrug-resistant tuberculosis[1].

Characteristics

Bedaquiline fumarate is the first diarylquinoline analogue used in the treatment of M. tuberculosis and its main biologically active form is bedaquiline. Bedaquiline fumarate forms three degradation products associated with fumaric acid (DP1, DP2 and DP3) under photolysis conditions and the demethylation product DP4 under acidic conditions. Bedaquiline forms four degradation products associated with tertiary alcohols and tertiary amine moiety side chains (IM1, IM2, IM3, and IM4) under photolysis conditions, and DP4 under acidic conditions.Both compounds are stable under thermal, alkaline and oxidative conditions. DP1 and DP2 show that fumarates can undergo cis-trans isomerisation under light conditions. The fumarate form stabilises the side chain of bedaquiline. It is advisable to avoid contact with acids and light during storage and production[2].

Definition

ChEBI: Bedaquiline fumarate is a fumarate salt prepared from equimolar amounts of bedaquiline and fumaric acid. It is used in combination therapy for the treatment of pulmonary multi-drug resistant tuberculosis by inhibition of ATP synthase, an enzyme essential for the replication of the mycobacteria. It has a role as an antitubercular agent and an ATP synthase inhibitor. It contains a bedaquiline(2+).

Clinical Use

Bedaquiline fumarate is a diarylquinone drug developed by Janssen Pharmaceutical which is marketed under the trade name Sirturo &#174;. The drug, which was approved in 2012 for the treatment of multidrug-resistant tuberculosis (MDR-TB), was developed in partnership with Johnson & Johnson and represents the first new tuberculosis therapy approved in over four decades. Bedaquiline is the first member of a new class of diarylquinone compounds whose mechanism of action inhibits Mycobaterium tuberculosis ATP synthase which deprives bacterium of energy.

Synthesis

Of the relatively few synthetic approaches to bedaquiline (or its fumarate salt) that have been reported, the most likely process-scale route is that described by Porstmann and co-workers from Janssen Pharmaceutical, and this route is outlined in the scheme. The synthesis was initiated by first freebasing commercially available dimethylaminoketone 31 with sodium hydroxide to provide naphthylone 32 in nearly quantitative yield. Subjection of commercially available quinoline 33 to LDA removed the benzyllic proton within this system and subsequent trap with naphthylone 32 gave rise to a mixture of diastereomers whereby the major diastereomer obtained from this reaction corresponded to the bedaquiline geometry. The minor diastereomer was resolved through multiple recrystallizations and seeding techniques. This racemate of the major diastereomer subsequently underwent a chiral resolution upon treatment with BINAP derivative 34 in refluxing DMSO and then upon cooling and subjection to aqueous base in warm toluene furnished bedaquiline 35 bearing the requisite (R,S)- configuration of the two vicinal chiral centers corresponding to that of the drug. The overall yield of the conversion of 33 to enantiopure 35 was 39%. Aminoquinolinol 35 was then prepared as the corresponding fumarate salt upon treatment with fumaric acid in the presence of isopropanol, and this salt formation delivered bedaquiline fumarate (VI) in 82% yield.

Drug interactions

Potentially hazardous interactions with other drugs
Antibacterials: concentration possibly increased by ciprofloxacin, clarithromycin and erythromycin - avoid concomitant use if for more than 14 days; avoid with moxifloxacin; concentration possibly reduced by rifampicin - avoid; possibly increased risk of ventricular arrhythmias with clofazimine.
Antiepileptics: concentration possibly reduced by carbamazepine, fosphenytoin and phenytoin - avoid.
Antivirals: AUC increased by ritonavir, use with caution, avoid in combination with lopinavir.

Metabolism

Bedaquiline is metabolised mainly by the hepatic CYP3A4 isoenzyme to the N-monodesmethyl metabolite (M2), which is 4-6 times less active than the parent compound. Bedaquiline is excreted mainly in the faeces.

References

[1] VISHWAS P PARDHI. Bedaquiline fumarate microemulsion: formulation optimization, rheological characterization and in vitro studies.[J]. Nanomedicine (London, England), 2022, 17 21: 1529-1546. DOI:10.2217/nnm-2022-0132.
[2] KAIJING GUO; Chen M; Yanan Wang. Characterization of stress degradation products of bedaquiline fumarate and bedaquiline by LC-PDA and LC-MS[J]. Journal of pharmaceutical and biomedical analysis, 2023. DOI:10.1016/j.jpba.2023.115658.

Bedaquiline fumarate Preparation Products And Raw materials

Raw materials

Preparation Products

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Bedaquiline fumarate Suppliers

Shanghai Xiang Xin Industrial Co., Ltd.
Tel
021-50211651 13651607026
Fax
+86-21-50211651
Email
sales@xxgmpharm.com
Country
China
ProdList
480
Advantage
58
ChengDu TongChuangYuan Pharmaceutical Co.Ltd
Tel
28-83379370 13880556291
Fax
028-87747383
Email
tcy@tcypharm.com
Country
China
ProdList
510
Advantage
57
Hebei Fanbo Pharmaceutical Technology Co., Ltd.
Tel
0531-88163906 15588346797
Email
fanbomedical@163.com
Country
China
ProdList
242
Advantage
58
Nanjing Tianyi Chemical Technology Co., Ltd
Tel
15150528611
Fax
151-5052-8611
Email
779881375@qq.com
Country
China
ProdList
68
Advantage
58
ChengDu TongChuangYuan Pharmaceutical Co.Ltd
Tel
028-83379370 13880556291
Fax
028-87747383
Email
tcy@tcypharm.com
Country
China
ProdList
5595
Advantage
58
Jiangsu Simcere Pharmaceutical CO.,Ltd
Tel
025-85566666-8770 15195996671
Email
API@simcere.com
Country
China
ProdList
19
Advantage
58
Hubei Kailong Biotechnology Co.,Ltd.
Tel
19526384105
Email
3671394075@qq.com
Country
China
ProdList
2864
Advantage
58
Energy Chemical
Tel
021-021-58432009 400-005-6266
Fax
021-58436166
Email
sales8178@energy-chemical.com
Country
China
ProdList
44689
Advantage
61
Dalian Meilun Biotech Co., Ltd.
Tel
0411-62910999 13889544652
Email
meilunui@163.com
Country
China
ProdList
4727
Advantage
58
Artis Chemistry (Shanghai) Co. Ltd.
Tel
86-21-60936353
Fax
86-21-60936352
Country
China
ProdList
335
Advantage
58
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View Lastest Price from Bedaquiline fumarate manufacturers

BEIJING SJAR TECHNOLOGY DEVELOPMENT CO., LTD.
Product
Bedaquiline fumarate 845533-86-0
Price
US $0.00/g
Min. Order
1g
Purity
More Than 99%
Supply Ability
100kg/Month
Release date
2024-09-06
WUHAN FORTUNA CHEMICAL CO., LTD
Product
Bedaquiline fumarate 845533-86-0
Price
US $0.00-0.00/g
Min. Order
1g
Purity
98%min
Supply Ability
100G
Release date
2021-06-18
PUSHAN INDUSTRIAL (SHAANXI) CO.,LTD
Product
Bedaquiline Fumarate 845533-86-0
Price
US $0.00/kg
Min. Order
1kg
Purity
98%
Supply Ability
500kgs
Release date
2024-06-13

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