Clozapine

Clozapine is an a typical antipsychotic medication apart from other uses. It is mainly used for schizophrenia that does not improve following the use of other antipsychotic medications.

Clozapine USP Grade
C18H19ClN4 --- 326.83
5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-.
8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine [5786-21-0].

Clozapine contains not less than 98.0 percent and not more than 102.0 percent of C18H19ClN4, calculated on the dried basis.

Packaging and storage: Preserve in well-closed containers.
Identification:
A: Infrared Absorption.
B: The RF value of the principal spot observed in the chromatogram of the Test solution corresponds to those of the principal spots observed in the chromatograms of the Standard solutions, as obtained in the test for Chromatographic purity.
Melting range: between 182C and 186C.
Loss on drying: Dry it at 105C for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition: not more than 0.1%.
Heavy metals: 0.002%.
Chromatographic purity: To pass the test.
Assay: Transfer about 115 mg of Clozapine, accurately weighed, to a suitable container, dissolve in 70 mL of glacial acetic acid, and titrate with 0.1 N perchloric acid, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 16.34 mg of C18H19ClN4.

Clozapine BP Ph Eur Grade
Ph. Eur.
C18H19ClN4 --- 326.8 --- 5786-21-0 
Action and use: Dopamine D4 receptor antagonist; neuroleptic.

DEFINITION
8-Chloro-11-(4-methylpiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: Yellow, crystalline powder.
Solubility: Practically insoluble in water, freely soluble in methylene chloride, soluble in ethanol (96 per cent). It dissolves in dilute acetic acid.

IDENTIFICATION
A. Melting point: 182C to 186C.
B. Infrared absorption spectrophotometry.

TESTS
Related substances: To pass the test by liquid chromatography.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

ASSAY
Dissolve 0.100 g in 50 mL of anhydrous acetic acid. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically. 1 mL of 0.1 M perchloric acid is equivalent to 16.34 mg of C18H19ClN4.

IMPURITIES
Specified impurities A, B, C, D
A. 8-chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one,
B. 11,11′-(piperazine-1,4-diyl)bis(8-chloro-5H-dibenzo[b,e][1,4]diazepine),
C. 8-chloro-11-(piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine,
D. 1-[2-[(2-amino-4-chlorophenyl)amino]benzoyl]-4-methylpiperazine.

Clozapine IP Grade
Clozapine is also in IP Pharmacopoeia.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.