Rocuronium Bromide USP BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Rocuronium Bromide USP BP Ph Eur 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. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Rocuronium Bromide CAS Number 119302-91-9, EINECS EC Number: 601-597-6, Molecular Formula: C32H53BrN2O4, Molecular Weight: 609.69, HS Code 29349990
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SDS MSDS Sheet of Rocuronium Bromide Manufacturers
Rocuronium Bromide
USP BP Ph Eur Grade Suppliers
Rocuronium bromide is an aminosteroid non-depolarizing neuromuscular blocker or muscle relaxant used in modern anaesthesia to facilitate tracheal intubation by providing skeletal muscle relaxation for surgery or mechanical ventilation. It is used for standard endotracheal intubation, as well as for rapid sequence induction. It can also be used with other drugs for medical assistance in dying.
General Properties and Specifications of Rocuronium Bromide:
Appearance: Almost white or pale yellow, slightly hygroscopic powder.
Assay: 99% minimum.
Melting Point: 162C to 164C, also reported is 169C literature.
Solubility: Freely soluble in water, very soluble in methylene chloride, freely soluble in anhydrous ethanol.
Storage: Preserve in tight containers, protected from light and moisture. Store in the freezer. If the article contains acetic acid, store it between 2C and 8C.
Rocuronium Bromide USP Grade Specifications:
C32H53BrN2O4 --- 609.68
Pyrrolidinium, 1-[(2β,3α,5α,16β,17β)-17-(acetyloxy)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl]-1-(2-propenyl)-, bromide;
1-Allyl-1-(3α,17β-dihydroxy-2β-morpholino-5α-androstan-16β-yl)pyrrolidinium bromide, 17-acetate
CAS 119302-91-9
UNII: I65MW4OFHZ
UNII: WRE554RFEZ
DEFINITION
Rocuronium Bromide contains NLT 98.0% and NMT 102.0% of rocuronium bromide (C32H53BrN2O4), calculated on anhydrous and 2-propanol-free or acetic acid-free basis.
IDENTIFICATION
A. Infrared Absorption
B. The retention time of the rocuronium bromide peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. Identification Tests—General, Bromide
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by chromatography.
Limit of 2-Propanol: To pass the test by chromatography.
Limit of Acetic Acid: To pass the test by chromatography.
Water Determination: NMT 4.0%
pH: 10 mg/mL. Acceptance criteria: 7.0–9.5
Optical Rotation, Specific Rotation: Sample solution: 10 mg/mL in 0.05 M hydrochloric acid. Acceptance criteria: ;28.5° –32.0°, measured on the anhydrous and solvent-free basis at 20C
Color and Achromicity: To pass the test.
Packaging and Storage: Preserve in tight containers, protected from light and moisture. Store in the freezer. If the article contains acetic acid, store it between 2° and 8°.
Rocuronium Bromide BP Ph Eur Grade:
C32H53BrN2O4 --- 610 CAS 119302-91-9
Action and use: Non-depolarizing neuromuscular blocker.
DEFINITION
1-[17β-Acetoxy-3α-hydroxy-2β-(morpholin-4-yl)-5α-androstan-16β-yl]-1-(prop-2-enyl)pyrrolidinium bromide.
Content: 99.0 per cent to 101.0 per cent (anhydrous substance).
CHARACTERS
Appearance: Almost white or pale yellow, slightly hygroscopic powder.
Solubility: Freely soluble in water, very soluble in methylene chloride, freely soluble in anhydrous ethanol.
IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Solution S (see Tests) gives reaction (a) of bromides.
TESTS
Solution S: Dissolve 0.10 g in carbon dioxide-free water and dilute to 10 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Specific optical rotation: + 28.5 to + 32.0 (anhydrous substance).
Dissolve 0.250 g in a 5.15 g/L solution of hydrochloric acid and dilute to 25.0 mL with the same solution.
pH: 8.9 to 9.5 for solution S.
Related substances: To pass the test by Liquid chromatography.
Chlorides: To pass the test by Liquid chromatography.
2-Propanol: Maximum 1.0 per cent.
Water: Maximum 4.5 per cent, determined on 0.400 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Storage: In an airtight container, protected from light, at a temperature below -15C.
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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Manufacturers:
MUBY CHEMICALS
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Rocuronium Bromide SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 30-Nov-20
1. Product Identification
Product Name & Other Names: Rocuronium Bromide.
CAS No.: 119302-91-9
EINECS EC Number: 601-597-6
Molecular Weight: 609.69
Chemical Formula: C32H53BrN2O4
Relevant uses and uses advised against (if any): Industrial use only.
Supplier: As per letterhead.
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 4), H302
Eye irritation (Category 2A), H319
Labeling according to GHS USA & Regulation (EC) No 1272/2008
GHS Label Elements  Irritant |
Signal Words: Warning
Hazard statements:
H302 Harmful if swallowed.
H319 Causes serious eye irritation.
Precautionary statements:
P262 Do not get in eyes, on skin, or on clothing.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P314 Get Medical advice/attention if you feel unwell.
P301+P312 IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313 If eye irritation persists: Get medical advice/ attention.
P330 Rinse mouth.
P360 Rinse immediately contaminated clothing and skin with plenty of water before removing clothes.
P501 Dispose of contents/ container to an approved waste disposal plant.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn = Harmful
Xi = Irritant
Risk Phrases:
R22 = Harmful if swallowed.
R36 = Irritating to eyes.
3. Composition/Information on Ingredients
Product Name & Other Names: Rocuronium Bromide.
CAS No.: 119302-91-9
EINECS EC Number: 601-597-6
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reusing. Thoroughly clean shoes before reuse.
Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Get medical attention.
5. Fire Fighting Measures
Fire: Not considered to be a fire hazard.
Explosion: It is not considered to be an explosion hazard.
Fire Extinguishing Media: Use any means suitable for extinguishing surrounding fire. Water spray may be used to keep fire exposed containers cool. Avoid solid water jet as it can scatter the 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. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved people should evacuate to a safe place.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Ventilate area of leak or spill. 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:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
Large Spill: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove it into an approved disposal container.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling it. 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. Avoid contact with eyes, skin, and clothing. 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 containers. 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: Preserve in tight containers, protected from light and moisture. Store in the freezer. If the article contains acetic acid, store it between 2C and 8C.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures below the Airborne Exposure Limits. 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. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details.
Personal Respirators (NIOSH Approved): If the exposure limit is exceeded and engineering controls are not feasible, a half face piece particulate respirator (NIOSH type N95 or better filters) may be worn for up to ten times the exposure limit or the maximum use concentration specified by the appropriate regulatory agency or respirator supplier, whichever is lowest. A full-face piece particulate respirator (NIOSH type N100 filters) may be worn up to 50 times the exposure limit, or the maximum use concentration specified by the appropriate regulatory agency, or respirator supplier, whichever is lowest. If oil particles (e.g. lubricants, cutting fluids, glycerin, etc.) are present, use a NIOSH type R or P filter. For emergencies or instances where the exposure levels are not known, use a full-face piece positive-pressure, air-supplied respirator.
Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron or coveralls, as appropriate, to prevent skin contact.
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. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.
9. Physical and Chemical Properties
Appearance: Almost white or pale yellow, slightly hygroscopic powder.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Boiling Point: Not available.
Melting Point: 162C to 164C, also reported is 169C literature.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor Density (Air=1): Not available.
Vapor Pressure (mm Hg): Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility(ies): Freely soluble in water, very soluble in methylene chloride, freely soluble in anhydrous ethanol.
Viscosity: Not available.
Molecular Weight: 609.69
Chemical Formula: C32H53BrN2O4
10. Stability and Reactivity
Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Decomposition forms hydrogen chloride and ammonia.
Hazardous Polymerization: Will not occur.
Incompatibilities: Concentrated acids, strong bases, silver salts, potassium chlorate, ammonium nitrate, bromine trifluoride and iodine heptafluoride. Ammonium Chloride reacts explosively with potassium chlorate or bromine trifluoride, and violently with bromide pentafluoride, ammonium compounds, nitrates, and iodine heptafluoride. Explosive nitrogen trichloride may result from reaction of ammonium chloride and hydrogen cyanide.
Conditions to Avoid: Heat, moisture, incompatibles.
11. Toxicological Information
Toxicity : Harmful if swallowed.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible, or confirmed human carcinogen by IARC.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.
12. Ecological Information
Toxicity to fish: Not available.
Persistence and Degradability: Unlikely to persist due to water solubility.
Mobility: Likely to be mobile due to water solubility.
Results of PBT and vPvB assessment: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
13. Disposal Considerations
Whatever cannot be saved for recovery, or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of containers and unused material in accordance with legal requirements.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not Regulated.
IMDG/IMO & IATA/ICAO: Not dangerous goods.: Not dangerous goods.
15. Regulatory Information
USA:
SARA 311/312: Immediate health hazard. See section 2.
California No Significant Risk Level: None of the chemicals in this product are listed.
16. Other Information
European Labeling in Accordance with EC Directives:
H302 Harmful if swallowed.
H319 Causes serious eye irritation.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn = Harmful
Xi = Irritant
Risk Phrases:
R22 = Harmful if swallowed.
R36 = Irritating to eyes.
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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