Melphalan IP BP Ph Eur EP USP Grade Manufacturers

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Melphalan IP BP Ph Eur EP USP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Melphalan 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: Melphalan or Melfalan
CAS Number: 148-82-3, Molecular Weight: 305.20, Chemical Formula: C13H18Cl2N2O2, EINECS EC Number: 205-726-3, FEMA: ----,

Melphalan or Melfalan is used as a chemotherapy medication. It is used in the treatment of multiple myeloma, advanced ovarian adenocarcinoma, early and advanced breast cancer, childhood neuroblastoma, and polycythaemia vera.

General Properties and Specifications of Melphalan or Melfalan:
Appearance: White to buff-colored powder.
Assay: 96%
Odor: Odorless or with a faint odor.
Melting Point: 180C to 183C literature.
Solubility: Practically insoluble in water.
Storage: Refrigerated. Sensitive to light, heat, and moisture. Short term shipping may be ambient.

Melphalan USP Grade Specifications:
C13H18Cl2N2O2 --- 305.20
l-Phenylalanine, 4-bis(2-chloroethyl)amino]-.
l-3-[ p-[Bis(2-chloroethyl)amino]phenyl]alanine
CAS 148-82-3
UNII: Q41OR9510P

Melphalan contains not less than 93.0 percent and not more than 100.5 percent of C13H18Cl2N2O2 calculated on the dried and ionizable chlorine-free basis.
Packaging and storage: Preserve in tight, light-resistant, glass containers.

Identification:
A: Ultraviolet Absorption
B: To 1 mL of 1 in 10,000 solution in alcohol in a glass-stoppered test tube add 1 mL of pH 4.0 acid phthalate buffer, 1 mL of a 1 in 20 solution of 4-(p-nitrobenzyl)pyridine in acetone, and 1 mL of saline TS. Heat on a water bath at 80C for 20 minutes, and cool quickly. Add 10 mL of alcohol and 1 mL of 1 N potassium hydroxide: a violet to red-violet color is produced.
C: Heat 100 mg with 10 mL of 0.1 N sodium hydroxide on a water bath for 10 minutes: the resulting solution, after acidification with 2 N nitric acid, responds to the tests for Chloride.

Specific rotation: between −30° and −36°.
Test solution: 7 mg per mL, in methanol, prepared with the aid of gentle heating.
Loss on drying: Dry it in vacuum at 105C to constant weight: it loses not more than 7.0% of its weight.
Residue on ignition: not more than 0.3%.
Ionizable chlorine: To pass the test.
Nitrogen Determination: To pass the test. Not less than 8.90% and not more than 9.45% of N is found, calculated on the dried basis.

Melphalan BP Ph Eur Grade Specifications:
C13H18Cl2N2O2 --- 305.2 CAS 148-82-3
Action and use: Cytotoxic alkylating agent.

DEFINITION
4-[Bis(2-chloroethyl)amino]-L-phenylalanine.
Content: 94.0 per cent to 102.0 per cent (anhydrous and diethylamine-free substance).

CHARACTERS
Appearance: White or almost white, hygroscopic powder.
Solubility: Practically insoluble in water, slightly soluble in methanol. It dissolves in dilute mineral acids.

TESTS
Appearance of solution: If intended for use in the manufacture of parenteral preparations, the solution is clear and colourless.
Dissolve 0.25 g in dilute hydrochloric acid and dilute to 25 mL with the same acid.
Specific optical rotation: -36.0 to -30.0 (anhydrous and diethylamine-free substance).
Dissolve 0.175 g at 45C for 10 min in methanol and dilute to 25.0 mL with the same solvent.
Related substances: To pass the test by liquid chromatography.
Impurity K (diethylamine): To pass the test by Gas chromatography.
Water: Maximum 5.0 per cent, determined on 0.200 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Storage: In an airtight container, protected from light.

Keywords: Melphalan IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 148-82-3 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.