Clozapine BP Ph Eur USP IP Grade Manufacturers

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Clozapine USP BP Ph Eur IP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Clozapine and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.

We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.

Synonyms: Clozapine
CAS Number: 5786-21-0, Molecular Weight: C18H19ClN4, Chemical Formula: 326.83, EINECS EC Number: 227-313-7, FEMA: ----,

Clozapine USP Grade Specifications
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 CAS 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 Specifications
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.

Keywords: Clozapine IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 5786-21-0 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.

Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.

All products are Sold for Industrial and Laboratory Use only. No other use is permitted.