CAS Number 148-82-3, Melphalan or Melfalan EP IP BP Ph Eur USP Grade Manufacturers Exporters
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CAS Number 148-82-3, Melphalan or Melfalan EP IP BP Ph Eur USP Grade Manufacturer Exporter
For Properties Specifications of Melphalan or Melfalan Click Properties, Specifications of Melphalan or Melfalan Manufacturer.
For Uses of Melphalan or Melfalan Click Uses of Melphalan or Melfalan Manufacturer.
For For SDS MSDS Sheet of Melphalan or Melfalan Click SDS Safety Data Sheet MSDS Sheet of Melphalan or Melfalan Manufacturer.
The Properties and Specifications of Melphalan or Melfalan:
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.
IDENTIFICATION
Infrared absorption spectrophotometry.
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.
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.
We also manufacture Melphalan IP EP Grade.
The Uses of Melphalan or Melfalan:
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.
The MSDS-SDS Hazard Statement of Melphalan or Melfalan:
Melphalan or Melfalan SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 24-Nov-24
Section 1. Product Information
Product Name/Trade Name: Melphalan or Melfalan.
CAS No.: 148-82-3
EINECS EC Number: 205-726-3
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
Section 2: Hazards Identification
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
GHS Label Elements  Health Hazard |
GHS Label Elements |
Signal Words: Danger
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.
Section 3: Composition and Information on Ingredients
Product Name/Trade Name: Melphalan or Melfalan.
CAS No.: 148-82-3
EINECS EC Number: 205-726-3
Chemical Formula: C13H18Cl2N2O2
Section 4. First Aid & Procedure
Always get medical attention after the first aid is over.
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.
Section 5. Fire Fighting Measures
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.
Section 6. Spills and Disposals
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.).
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.
Section 7. Handling and Storage
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.).
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 inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Storage: Refrigerated. Sensitive to light, heat, and moisture.
Section 8. Exposure Controls & Personal Protection
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 low.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
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.
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.
Section 9. Physical & Chemical Data
Physical State: White to buff-colored powder.
Odor: Odorless or with a faint odor.
Odor threshold: No data found.
pH: No data found.
Relative density: No data found.
Melting Point: 180C to 183C literature.
Initial boiling point and boiling range: No data found.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility in water: Practically insoluble in water.
Viscosity: No data found.
Section 10. Stability and Reactivity
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.
Section 11. Toxicological Information
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.
Section 12. Ecological Information
Ecotoxicity: No data found.
Persistence and Degradability: No data found.
Mobility: No data found.
Bioaccumulation/ Accumulation: No data found.
Results of PBT and vPvB assessment: No data found for assessment.
Environmental Precautions: DO NOT DISCHARGE into drains and rivers.
Section 13. Disposal Suggestions
Dispose of in accordance with all applicable local, state, and federal regulations at an approved waste disposal facility. Follow all the pollution control rules.
Section 14. Transport and Label Information
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).
Section 15. Regulatory Information
USA:
SARA 311/312: See section 2.
California Prop.65: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.
Section 16. Other Information
DISCLAIMER: The information and recommendations set forth herein are presented in good faith and believed correct as of the date hereof. It is compiled from various sources, and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules, or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a professionally trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.
Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
Melphalan or Melfalan Structure
CAS Number 148-82-3, Melphalan or Melfalan Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 24-nov-24
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