99.6% High Purity Solifenacin Succinate CAS: 242478-38-2


Product Name: Solifenacin Succinate
CAS NO.: 242478-38-2
Chemical Name: 1-Azabicyclo[2.2.2]octan-8-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate butanedioic acid
Chemical Formula: C23H26N2O2.C4H6O4
Aspect: White Crystalline powder
Purity: 98.5% min.
Loss on drying: 1.0% max.
Assay: 98.0%-100.0%
Heavy Metal: 20ppm max.
Standard: Enterprise Standard
APIS: Medetomidine Hcl, Dexmedetomidine Hcl, Detomidine Hcl, Dofetilide, Emedastine Difumarate, Tigecycline, Entecavir, Solifenacin Succinate, Octreotide Acetate, Tiotropium Bromide, Methyl di(2-thienyl)glycolate, Scopine Hydrochloride, Scopine Di(2-thienyl)glycolate, 4-pyridinecarboxaldehyde, N-benzylpiperidine-4-carboxyaldehyde.



Details:
Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each VESIcare tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each VESIcare tablet also contains the following inert ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare tablet) or red ferric oxide (10 mg VESIcare tablet).


Dosage and Administration:
Adults:PO 5 mg once daily. If 5 mg dose is well-tolerated, the dose may be increased to 10 mg/day.


Warnings/Precautions:
Severe hepatic impairment: not recommended. Bladder outflow obstruction. GI obstructive disorders. Decreased GI motility. Controlled narrow-angle glaucoma. History of QT prolongation. Renal or hepatic insufficiency. Monitor for signs of CNS effects esp. after initiating treatment or dose increases; consider dose reduction or discontinue if occurs. Exposure to high environmental temperature. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

 

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