Fexofenadine Hydrochloride IP BP Ph Eur EP JP USP Grade Manufacturers

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Fexofenadine HCl or Fexofenadine Hydrochloride IP BP Ph Eur EP JP USP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Fexofenadine HCl or Fexofenadine Hydrochloride 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: Fexofenadine HCl or Fexofenadine Hydrochloride
CAS Number: 138452-21-8 or 153439-40-8, Molecular Weight: 538.12, Chemical Formula: C32H39NO4-HCl, EINECS EC Number: 604-906-2, FEMA: ----,

Fexofenadine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine.

Fexofenadine Hydrochloride USP Grade Specifications:
C32H39NO4-HCl --- 538.12
Benzeneacetic acid, 4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, hydrochloride, (±)-;
(±)-p-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidino]butyl]-α-methylhydratropic acid, hydrochloride 138452-21-8
UNII: 2S068B75ZU

DEFINITION
Fexofenadine Hydrochloride contains NLT 98.0% and NMT 102.0% of fexofenadine hydrochloride (C32H39NO4-HCl), calculated on the anhydrous basis.

IDENTIFICATION
A. Infrared Absorption
B. The retention time of the fexofenadine peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. Examine the precipitate formed in Other Components for the Content of Chloride test.
Acceptance criteria: A white precipitate is observed.
Content of Chloride: 6.45%–6.75% on the anhydrous basis.
Residue on Ignition: NMT 0.1%
Limit of Fexofenadine Related Compound B: To pass the test by chromatography.
Other Organic Impurities: To pass the test by chromatography.
Water Determination: NMT 2.0% for the anhydrous form; 6.0%–10.0% for the hydrate form. [Note— “Hydrate” refers to a mixture of dihydrate and trihydrate forms of fexofenadine hydrochloride.]
Packaging and Storage: Preserve in well-closed, light-resistant containers, and store at controlled room temperature.

Fexofenadine Hydrochloride BP Ph Eur Grade Specifications:
C32H40ClNO4 --- 538.1 CAS 153439-40-8

DEFINITION
2-[4-[(1RS)-1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid hydrochloride.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Slightly soluble in water, freely soluble in methanol, very slightly soluble in acetone.
It shows polymorphism.

IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Dissolve 30 mg of the substance to be examined in a mixture of equal volumes of methanol and water; sonicate if necessary and dilute to 2 mL with the same mixture of solvents. The solution gives reaction of chlorides.

TESTS
Impurity B: To pass the test by Liquid chromatography.
Related substances: To pass the test by Liquid chromatography.
Water: Maximum 0.5 per cent.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

Keywords: Fexofenadine HCl or Fexofenadine Hydrochloride IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 138452-21-8 or 153439-40-8 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.