Ketoconazole IP BP Ph Eur EP JP USP Grade Manufacturers

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Ketoconazole IP BP Ph Eur EP JP USP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Ketoconazole 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: Ketoconazole or (±)-cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.
CAS Number: 65277-42-1, Molecular Weight: 531.43, Chemical Formula: C26H28Cl2N4O4, EINECS EC Number: 265-667-4, FEMA: ----,

Ketoconazole is an antiandrogen, antifungal, and antiglucocorticoid medication used to treat several fungal infections. It works by killing the fungus or yeast or preventing its growth.

General Properties and Specifications of Ketoconazole:
Synonyms: (±)-cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.
Appearance: White to Almost white powder to crystal.
Assay: 98%
Relative Density: about 1.4
Melting Point: 148C to 152C literature.
Boiling Point: about 753C predicted.
Solubility: Soluble in methanol.
Storage: Refrigerated (0-10C). Ok to freeze. Protected from light. Heat Sensitive.

Ketoconazole USP Grade Specifications:
C26H28Cl2N4O4 --- 531.43
Piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis-;
(±)-cis-1-Acetyl-4-(p-[[2-(2,4-dichlorophenyl)-2-(imidazol-1- ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl)piperazine
CAS 65277-42-1
UNII: R9400W927I

DEFINITION
Ketoconazole contains NLT 98.0% and NMT 102.0% of ketoconazole (C26H28Cl2N4O4 ), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by chromatography system.
Optical Rotation, Specific Rotation:
Sample solution: 40 mg/mL in methanol
Acceptance criteria: −1° to +1° at 20C.
Loss on Drying: Dry under vacuum at 80C for 4 h. Acceptance criteria: NMT 0.5%
Packaging and Storage: Preserve in well-closed containers.

Ketoconazole BP Ph Eur Grade Specifications:
C26H28Cl2N4O4 -- 531.4 CAS 65277-42-1
Action and use: Antifungal.

DEFINITION
1-Acetyl-4-[4-[[(2RS,4SR)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in ethanol (96 per cent).

IDENTIFICATION
First identification: B
Second identification: A, C, D
A. Melting point: 148C to 152C.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography
D. To about 30 mg in a porcelain crucible add 0.3 g of anhydrous sodium carbonate. Heat over an open flame for 10 min. Allow to cool. Take up the residue with 5 mL of dilute nitric acid and filter. To 1 mL of the filtrate add 1 mL of water. The solution gives reaction of chlorides.

TESTS
Solution S:
Dissolve 1.0 g in methylene chloride and dilute to 10 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Optical rotation: -0.10° to + 0.10°, determined on solution S.
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.
Storage: Protected from light.

Keywords: Ketoconazole IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 65277-42-1 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.