Tamsulosin Hydrochloride or Tamsulosin HCl USP IP BP Ph Eur JP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Tamsulosin Hydrochloride or Tamsulosin HCl USP IP BP Ph Eur JP 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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Tamsulosin Hydrochloride or Tamsulosin HCl CAS Number 106463-17-6, EINECS EC Number: 629-756-5, Molecular Formula: C20H29ClN2O5S or C20H28N2O5S- HCl, Molecular Weight: 444.98, HS Code 29359090 or 29350090 or 29420090

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

Tamsulosin Hydrochloride is used to relieve symptoms of urinary obstruction caused by enlarged prostate.

Tamsulosin Hydrochloride USP Grade Specifications:
C20H28N2O5S-HCI --- 444.97
Benzenesulfonamide, 5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxy-, monohydrochloride, (R)-;
(−)-(R)-5-[2-[[2-(o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide monohydrochloride
CAS 106463-17-6
UNII: 11SV1951MR
UNII: G3P28OML5I

DEFINITION
Tamsulosin Hydrochloride contains NLT 98.0% and NMT 102.0% of tamsulosin hydrochloride (C20H28N2O5S-HCl), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption
B. Identification Tests—General, Chloride
C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Residue on Ignition: NMT 0.1%
Organic Impurities, Procedure 1: To pass the test by chromatography.
Organic Impurities, Procedure 2: To pass the test by chromatography.
Enantiomeric Purity: To pass the test by chromatography.
Loss on Drying: Dry at 105C for 2 h. Acceptance criteria: NMT 0.5%
Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.

Tamsulosin Hydrochloride BP Ph Eur Grade:
C20H29ClN2O5S --- 445.0 CAS 106463-17-6
Action and use: Alpha-1-adrenoceptor antagonist.

DEFINITION
5-[(2R)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide hydrochloride.
Content: 98.5 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol.
Melting Point: About 230C.

IDENTIFICATION
Carry out either tests A, C, D or tests A, B, D.
A. Infrared absorption spectrophotometry.
B. Specific optical rotation: -20.5 to -17.5 (dried substance).
C. Enantiomeric purity.
D. Dissolve with heating 0.75 g in water and dilute to 100.0 mL with the same solvent. Take 5 mL of the solution and cool in an ice-bath. Add 3 mL of dilute nitric acid and shake. Allow to stand at room temperature for 30 min and filter. The filtrate gives reaction of chlorides.

TESTS
Related substances: To pass the test by liquid chromatography.
Enantiomeric purity: To pass the test by liquid chromatography.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C for 2 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

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.

MUBY CHEMICALS
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TEL: (OFFICE) +912223770100, +912223726950
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Tamsulosin Hydrochloride SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 22-Sept-24

Product Name & Other Names: >Tamsulosin Hydrochloride.
CAS No.: 106463-17-6
EINECS EC Number: 629-756-5
Molecular Weight: 444.98
Chemical Formula: C20H29ClN2O5S or C20H28N2O5S- HCl
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 4, H302
Skin corrosion/irritation Category 2, H315
Serious eye damage/eye irritation Category 2A, H319
Specific target organ toxicity, single exposure; Respiratory tract irritation Category 3, H335

Hazard statements:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.

Precautionary statements:
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash skin thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
P273: Avoid release to the environment.
P330: Rinse mouth.
P362: Take off contaminated clothing and wash before reuse.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P332+313: If skin irritation occurs: Get medical advice/attention.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P332+313: If skin irritation occurs: Get medical advice/attention.
P337+P313 If eye irritation persists: Get medical advice/ attention.
P501: Dispose of contents/container to authorized agents only.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xi Irritant.
Xn Harmful.
Risk Phrase:
R22: Harmful if swallowed.
R36/37/38: Irritating to eyes, respiratory system & skin.

Product Name & Other Names: Tamsulosin Hydrochloride.
CAS No.: 106463-17-6
EINECS EC Number: 629-756-5

Inhalation: Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Keep person warm and quiet; get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact: Immediately flush skin with plenty of soap and water for at least 15 minutes. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention if irritation develops.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention.

Fire: May become a fire hazard at high temperatures.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Avoid solid water jet as it can scatter the fire.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Sulfur oxides, Hydrogen chloride gas.
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 a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Use personal protective equipment. Avoid dust formation. 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: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. 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. Do not leave the material container open. 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. Avoid dust formation and control ignition sources. Storage: Room Temperature. Recommended in a cool and dark place, <15C. Hygroscopic. Protect from light. Short term shipping may be at ambient temperature.

Airborne Exposure Limits: None established.
Ventilation System: In general, dilution ventilation is a satisfactory health hazard control for this substance. However, if conditions of use create discomfort to the worker, a local exhaust system should be considered.
Personal Respirators (NIOSH Approved): Not expected to require personal respirator usage. For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator (NIOSH type N95 or better filters) may be worn. 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 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.

Appearance: White to beige powder.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Boiling Point: Decomposes.
Melting Point: 595.5C literature.
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: Soluble in DMSO, methanol, and water.
Viscosity: Not available.
Molecular Weight: 444.98
Chemical Formula: C20H29ClN2O5S or C20H28N2O5S- HCl

Stability: It is stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: May produce oxides of nitrogen, sulfur and carbon along with chlorine compounds and fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flame, ignition sources, dusting and incompatibles.

650 mg/kg LD50 oral rat.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Germ cell mutagenicity: No data available.
Reproductive toxicity: No data available.

Toxicity: No data available.
Persistence and degradability: Unlikely to persist due to water solubility.
Bioaccumulative potential: Unlikely to accumulate 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.

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. Dispose of containers and unused material in accordance with legal requirements.

DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IATA/ICAO: Not regulated.
IMDG/IMO: Not regulated.

USA:
SARA 313: Not applicable
SARA 311/312 Hazardous Categorization: Acute Health Hazard.
California Proposition 65: This product does not contain any Proposition 65 chemicals.

European Labeling in Accordance with EC Directives:
H302 = Harmful if swallowed.
H315 = Causes skin irritation.
H319 = Causes serious eye irritation.
H335 = May cause respiratory irritation.

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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