Felodipine EP BP Ph Eur USP NF IP Grade Manufacturers

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Felodipine USP NF EP BP Ph Eur IP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Felodipine 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: Felodipine
CAS Number: 72509-76-3 or 86189-69-7, Molecular Weight: 384.25, Chemical Formula: C18H19Cl2NO4, EINECS EC Number: 620-472-7, FEMA: ----,

Felodipine is a medication used in the management and treatment of essential hypertension. It is a member of the dihydropyridine class of calcium channel blockers. Reduction in blood pressure lowers the risk of cardiovascular morbidity and mortality.

General Properties and Specifications of Felodipine:
Appearance: Light yellow to yellow crystalline powder.
Solubility: freely soluble in acetone and methanol. Very slightly soluble in heptane. Insoluble in water.
Identification: by IR and by HPLC.
Assay: 98% to 101%
Residue on ignition: 0.1% maximum.
Loss on drying: 0.5% maximum.
Color of the solution 20mg/ml in methanol: < 0.2 absorbance.
Limit of Ethyl 3-Aminocrotanate: 0.15% maximum.
Methyl Benzylidene acetoacetate: 0.15% maximum.
Felodipine related compound A: 0.15% maximum.
Sum of dimethyl felodipine and diethyl felodipine: 1% maximum.
Any unspecified impurity: 0.1% maximum.
Total impurities: 1.5% maximum.
Residual solvent Isopropyl Alcohol: 5000 ppm maximum.
Particle size: D90 Less than 10 µm.
Relative Density: about 1.28
Melting Point: 145C literature.
Boiling Point: 472C literature.
Solubility: Practically insoluble in water.
Storage: At room temperature in light-resistant containers.

Felodipine USP Grade Specifications:
C18H19Cl2NO4 --- 384.25
3,5-Pyridinedicarboxylic acid 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, ethyl methyl ester, (±)-;
(±)-Ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate CAS 72509-76-3, 86189-69-7
UNII: OL961R6O2C

DEFINITION
Felodipine contains NLT 98.0% and NMT 101.0% of felodipine (C18H19Cl2NO4), 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. Maximum 1.5%
Loss on Drying: Dry the sample at 105C for 3 h. Acceptance criteria: NMT 0.5%
Color of Solution: To pass the test.

Felodipine BP Ph Eur Grade:
C18H19Cl2NO4 --- 384.3 --- CAS 72509-76-3
Action and use: Calcium channel blocker.

DEFINITION
Ethyl methyl (4RS)-4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or light yellow, crystalline powder.
Solubility: Practically insoluble in water, freely soluble in acetone, in anhydrous ethanol, in methanol and in methylene chloride.

IDENTIFICATION
First identification: B
Second identification: A, C, D
A. Ultraviolet and visible absorption spectrophotometry.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography
D. Ultraviolet and visible absorption spectrophotometry.

Solution S: Dissolve 1.00 g in methanol and dilute to 20.0 mL with the same solvent.
Appearance of solution: Solution S is clear.
Absorbance: Maximum 0.10, determined at 440 nm on solution S.
Related substances: To pass the test.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C for 3 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

Keywords: Felodipine IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade Manufacturer Supplier Exporter CAS Number 72509-76-3 86189-69-7 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.