Tadalafil or Tadanafil BP Ph Eur USP EP Grade Manufacturers

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Tadalafil or Tadanafil USP BP Ph Eur EP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Tadalafil or Tadanafil 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: Tadalafil or Tadanafil
CAS Number: 171596-29-5, Molecular Weight: 389.41, Chemical Formula: C22H19N3O4, EINECS EC Number: 687-782-2, FEMA: ----,

Tadalafil or Tadanafil used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

General Properties and Specifications of Tadalafil or Tadanafil:
Appearance: White to Light yellow powder to crystal. Air Sensitive, Heat Sensitive.
Assay: >98%
Relative Density: 1.5 predicted.
Melting Point: 301C - 302C literature.
Solubility: Very slightly soluble in water. Soluble in DMF and DMSO.
Storage: Refrigerated (0-10°C).

Tadalafil BP Ph Eur Grade Specifications:
C22H19N3O4 --- 389.4 CAS 171596-29-5
Action and use: Selective inhibitor of cyclic GMP-specific phosphodiesterase (Type V) with vasodilator action; treatment of erectile dysfunction.

DEFINITION
(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1′,2′:1,6]-pyrido[3,4-b]indole-1,4-dione.
Content: 97.5 per cent to 102.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride.

IDENTIFICATION
Carry out either tests A, B or tests A, C.
A. Infrared absorption spectrophotometry.
B. Liquid chromatography: to pass the test.
C. Specific optical rotation: + 78.0 to + 84.0 (dried substance).
Dissolve 0.250 g in dimethyl sulfoxide and dilute to 25.0 mL with the same solvent.
TESTS
Impurities A, B and C: To pass the test by Liquid chromatography.
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 vacuo at 105C for 3 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

Tadalafil USP Grade Specifications:
C22H19N3O4 --- 389.40
Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R -12aR )-;
(6R ,12aR )-2,3,6,7,12,12a-Hexahydro-2-methyl-6-[3,4-(methylenedioxy)phenyl] pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione CAS 71596-29-5
UNII: 742SXX0ICT

DEFINITION
Tadalafil contains NLT 97.5% and NMT 102.5% of tadalafil (C22H19N3O4 ), 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 Identification solution, as obtained in the test for Enantiomeric and Diastereomeric Purity.

Residue on Ignition: NMT 0.10%, using a 1-g sample
Organic Impurities: To pass the test by chromatography.
Enantiomeric and Diastereomeric Purity: To pass the test.
Loss on Drying: Dry a sample under vacuum at 105C for 3 h. Acceptance criteria NMT 0.5%
Packaging and Storage: Preserve in well-closed containers. Store at room temperature.

Keywords: Tadalafil or Tadanafil IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 171596-29-5 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.