Topiramate

Topiramate

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. It is also Food and Drug Administration (FDA) approved for, and most frequently prescribed for, the prevention of migraines. The drug is also used to treat migraines due to the effect it has on the blood vessels in the brain. It has been found to be increasingly effective for migraine sufferers with limited side effects.

Psychiatrists have used topiramate to treat bipolar disorder, although the available evidence does not support its use in any phase of bipolar disorder treatment.A more recent review, published in 2010, suggested a benefit of topiramate in the treatment of symptoms of borderline personality disorder, however the authors note that this was based only on one randomized controlled trial and requires replication. Also the authors noted that the long-term effects have not been studied.

This drug has been used as a treatment for alcoholism, obesity and antipsychotic-induced weight gain.

SR NO. ITEM SPECIFICATION
1 DESCRIPTION A White to off-white crystlline powder
2 SOLUBILITY Freely soluble in Dichloromethane and soluble in methanol
3 IDENTIFICATION
a)IR absorption The infrared spectrum of the test subtance should concordant with that of standard spectrum
b) HPLC test The retention time of the major peak in the chromatogramof the sample preparation corresponds to that of standard
4 MELTING RANGE 120.0 ˚C ~130.0˚C
5 WATER CONTENT NMT 0.5% W/W
6 SPECIFIC OPTICAL ROTATION AT 20 ˚c
(on anhydrous basis, 0.4% in methanol)
28.0 to -35.0
7 RESIDUE ON IGNITION NMT 0.2%
8 RELATED SUBSTANCE BY HPLC
a) Fructose
b) Related compound A
c) Topiramate impurity
d) TP2 Compound
e) Any other individual impurity
f) Total impurities

NMT 0.1%
NMT 0.1%
NMT 0.1%
NMT 0.1%
NMT 0.1%
NMT 0.5%
9 LIMIT OF SULPHAMATE AND SULPHATE BY HPLC
a) Fructose
b) Related compound A

NMT 0.1%
NMT 0.1%
10 ASSAY BY HPLC (on anhydrous basis) 98.0% w/w ~ 102.0% w/w
11 RESIDUAL SOLVENTS
a) Acetone
b) Iso propyl alcohol
c) Acetonitrile
d) Methylene chloride
e) n- Hexane
f) Ethyl acetate
g) pyridine
h) other class 1,2,3 residual solvent
and other organic solvent

NMT 1500 ppm
NMT 1500 ppm
NMT 300 ppm
NMT 250 ppm
NMT 200 ppm
NMT 2000 ppm
NMT 7d ppm
Meets the requirement of other class 1,2 and 3
residual solvents as per USP 467 and no other
organic solvents are present
12 TAPPED DENSITY 0.7 g/ml ~ 1.1 g/ml
13 PARTICAL SIZE
(By laser diffraction) D90(Micro meters)
80.0 ~ 350.0
14 MICROBIAL ENUMERATION TESTS
-- Total aerobic microbial count
-- Total combined yeasts and molds count
-- Total combined yeasts and molds count
   - Escherichia coli
   - Salmonella
   - Pseudomonas aeruginosa
   - Staphycoccus aures

NMT 1000cfu/g
NMT 1000cfu/g

Should be absent
Should be absent
Should be absent
Should be absent