Melphalan USP BP Ph Eur IP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Melphalan USP BP Ph Eur IP Grade, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy Portugal, Bangladesh, etc.

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Melphalan CAS Number 148-82-3, EINECS EC Number: 205-726-3, Molecular Formula: C13H18Cl2N2O2, Molecular Weight: 305.20, HS Code 29224999

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Melphalan.

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.

For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

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Melphalan or Melfalan SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 22-Sept-24

Product Name/Trade Name: Melphalan or Melfalan.
CAS No.: 148-82-3
EINECS EC Number: 205-726-3
Chemical Formula: C13H18Cl2N2O2
Molecular Weight: 305.20
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Acute toxicity, Oral (Category 2), H300
Skin sensitization (Category 1), H317
Germ cell mutagenicity (Category 1A), 1B, H340
Carcinogenicity (Category 1A), H350
Reproductive toxicity (Category 2), H361

Labeling according to GHS & Regulation (EC) No 1272/2008

Hazard statements:
H300 Fatal if swallowed.
H317 May cause an allergic skin reaction.
H340 May cause genetic defects.
H350 May cause cancer.
H361 Suspected of damaging fertility or the unborn child.

Precautionary statements:
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P270: Do not eat, drink, or smoke when using this product.
P281: Use personal protective equipment as required.
P330: Rinse mouth.
P301+310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P308+313: IF exposed or concerned: Get medical advice/attention.
P405: Store locked up.
P501: Dispose of contents/container in accordance with local/regional/national/international regulation.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
T+ Toxic
Xn Harmful
Risk Phrase:
R28 Very toxic if swallowed.
R43 May cause sensitization by skin contact.
R45 May cause cancer.
R46 May cause inheritable genetic damage.
R61 May cause harm to the unborn child.

Product Name/Trade Name: Melphalan or Melfalan.
CAS No.: 148-82-3
EINECS EC Number: 205-726-3
Chemical Formula: C13H18Cl2N2O2

Ingestion: Never give anything by mouth to an unconscious person. Get medical attention.
Skin: Immediately flush skin with plenty of water for at least 15 minutes. Remove and wash contaminated clothing and shoes before reuse. Get medical attention if irritation develops.
Eyes: Immediately flush eyes with plenty of water for 15 minutes, occasionally lifting upper and lower eyelids. Hold eyelids apart during irrigation. Get medical attention.
Inhalation: Remove person to fresh air. If breathing is difficult, give oxygen. If not breathing administer artificial respiration. Get medical attention.

Fire/Explosion: Not considered to be a fire and explosion hazard. However, it can burn at high temperature.
Extinguishing Medium: Water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Avoid solid water jet as it may scatter the fire.
Special hazards arising from the substance or mixture: Chlorine compounds, Carbon oxides & Nitrogen oxides, Fumes may evolve.
Fire Fighting Instructions: Use suitable protective equipment for surrounding fire.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes.

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Storage: Refrigerated. Sensitive to light, heat, and moisture. Short term shipping may be ambient.

Exposure Limits: This product, as supplied, does not contain any hazardous materials with occupational exposure limits established by the region specific regulatory bodies.
Engineering Controls: Use adequate exhaust ventilation to keep airborne concentrations below the allowable exposure limit.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Physical State: White to buff-colored powder.
Odor: Odorless or with a faint odor.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting Point: 180C to 183C literature.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility in water: Practically insoluble in water.
Viscosity: Not available.
Chemical Formula: C13H18Cl2N2O2
Molecular Weight: 305.20

Chemical Stability: Stable under recommended temperatures and pressures.
Incompatibility (Materials to Avoid): Oxidizing agents. Sensitive to light, heat, and moisture.
Conditions to Avoid: Incompatible materials, exposure to moist air or water, excessive heat, and light.
Hazardous Decomposition Products: Chlorine compounds, Carbon oxides, Nitrogen oxides, Fumes.
Hazardous Polymerization: Will not occur.

Toxicity to Animals: LD50 Oral - Rat - 26 mg/kg.
Carcinogenicity: Group 1. Carcinogenicity to humans.
Specific target organ toxicity: May cause genetic defects. Fatal if swallowed. Suspected human reproductive toxicant.

Ecotoxicity: No data available.
Persistence and Degradability: No data available.
Mobility: No data available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.
Environmental Precautions: DO NOT DISCHARGE into drains and rivers.

Dispose of in accordance with all applicable local, state, and federal regulations at an approved waste disposal facility.

DOT USA, TDG Canada & ADR/RID Europe:
UN number: 2811
Hazard class: 6.1; Packing group: II
Proper shipping name: Toxic solid, organic, n.o.s. (Melphalan).
IMDG/IMO:
UN number: 2811
Hazard class: 6.1; Packing group: II
Proper shipping name: Toxic solid, organic, n.o.s. (Melphalan).
IATA:
UN number: 2811
Hazard class: 6.1; Packing group: II
Proper shipping name: Toxic solid, organic, n.o.s. (Melphalan).

USA:
SARA 311/312: Chronic Health Hazard.
California Prop.65: WARNING! This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.

European Labeling in Accordance with EC Directives:
H300 Fatal if swallowed.
H317 May cause an allergic skin reaction.
H340 May cause genetic defects.
H350 May cause cancer.
H361 Suspected of damaging fertility or the unborn child.

Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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