Pharmaceutical Apis Tolvaptan for Hyponatremia CAS 150683-30-0

/ October 30, 2018

  • Model NO.: 150683-30-0
  • Customized: Non-Customized
  • Suitable for: Adult
  • Purity: >99%
  • Synonym: Tolvaptan
  • MW: 448.94
  • Melting Point: 219-222′c
  • Grade: Pharma Grade
  • MOQ: 10g
  • Transport Package: Discreet Package
  • Origin: China
  • Powder: Yes
  • Certification: HSE, ISO 9001
  • State: Solid
  • CAS: 150683-30-0
  • Mf: C26h25cln2o3
  • Appearance: White Powder
  • Solubility: DMSO: ≥15mg/Ml
  • Usage: Treat Hyponatremia
  • Trademark: Saichuang
  • Specification: Enterprise standard
Pharmaceutical APIs Tolvaptan for Hyponatremia CAS 150683-30-0


Quick Detail
Product Name
Tolvaptan
 
Synonym
N-[4-(9-chloro-6-hydroxy-2-azabicyclo[5.4.0]undeca-8,10,12-triene-2-carbonyl)-3-methyl-phenyl]-2-methyl-benzamide;N-[4-[(5R)-7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl]-3-methylphenyl]-2-methylbenzamide;Tolvaptan;OPC 41061;OPC-41061;SaMsca;Tolvaptan Tablets;N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-Methylphenyl)-2-MethylbenzaMide
 
CAS
150683-30-0
 
MF
C26H25ClN2O3
 
MW
448.94
 
EINECS
1308068-626-2
 
Purity
99%
 
Appearance
White Powder
 
Melting Point
219-222°C
 
Solubility
DMSO: ≥15mg/mL
 
Grade
Pharma Grade
 
Usage
Tolvaptan (OPC-41061) is a selective, competitive arginine vasopressin receptor 2 antagonist with an IC50 of 1.28μM for the inhibition of AVP-induced platelet aggregation. Tolvaptan (OPC-41061) is used to treat hyponatremia (low blood sodium levels) assoc.
 



Topiramate Description
 
Topiramate is an anticonvulsant that antagonizes GluR5 receptors (IC50 = 0.46 μM) and acts as a positive allosteric modulator of GABAA receptor-mediated currents. This compound inhibits Nav channels (IC50 = 48.9 μM) and inhibits L-type Ca2+ channels. Topiramate inhibits carbonic anhydrase (CA) (Ki values are 0.1 and 0.2 μM in rat CA II and CA IV, respectively).
 

Topiramate COA
Items Specifications
Results
 
Appearance White to off-white powder, Freely soluble in dichloromethane
White powder, Freely soluble in dichloromethane
 
Identification Infared Absorption
Complies
 

The retention time of the major peak in the chromatogram of the Assay prepration corresponds to that in the chromatogram of the standard preparation, as obtained in the assay
 		 complies
Specific rotation Between -28.6°and -35.0°, measured at 20°
-32.8°
 
Water not more than 0.5%
0.12%
 
residue on ignition not more than 0.2%
0.11%
 
Heavy metals not more than 0.001%
complies
 
Related compounds by HPLC(Test1) Fructose not more than 0.3%
Compound A not more than 0.3%
Other individual impurity not more than 0.1% 
Total impurities not more than0.5%                      
Fructose: 0.03%        
CompoundA:0.04%
individual impurity           
Total impurities: 0.07%
 
Particle size 90% less than 350 microns
complies
 
Limit of sulfamate and sulfate
Sulfamate ion not more than 0.10%
Sulfate ion not more than 0.10%
 		 complies
Residual Solvent
Methylene Chloride not more than 250μg/g
 		 not detected

Acetone not mor than 2500μg/g
 

Isopropanol not more than 5000μg/g
 

Ethanenitrile not more than 400μg/g
 

N-hexane not more than 290μg/g
 

Ethyl Acetate not more than 2500μg/g
 

Pyridine not more than 100μg/g
 
Assay
Topiramate contains not less than 98.0% and
not more than the equivalent of 102.0% of C12H21NO8S, calculated with reference to the Anhydrous Basis
 		 99.80%
Conclustion
The material complies with respect to USP35
 

 
Topiramate Usage 
 
Topiramate is used to treat epilepsy in children and adults, and it was originally used as an anticonvulsant.
In children, it is indicated for the treatment of Lennox-Gastaut syndrome, a disorder that causes seizures and
developmental delay.


Precaution:

Tolvaptan(SAMSCA) should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.

Tolvaptan(SAMSCA) is contraindicated in the following conditions:
Urgent need to raise serum sodium acutely
Inability of the patient to sense or appropriately respond to thirst
Hypovolemic hyponatremia
Concomitant use of strong CYP 3A inhibitors
Anuric patients
Hypersensitivity (e.g. anaphylactic shock, rash generalized) to tolvaptan or its components

Annual Hot Products Topiramate Antiepileptic Drugs CAS97240-79-4

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