Timolol Maleate IP BP EP Ph Eur JP USP Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Timolol Maleate IP BP EP Ph Eur JP USP , 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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Timolol Maleate CAS Number 26921-17-5 or 60469-65-0, EINECS EC Number: 248-111-5, Molecular Formula: C13H24N4O3S-C4H4O4 or C17H28N4O7S, Molecular Weight: 432.49, HS Code 29349990

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

Timolol is a beta blocker medication used either by mouth or as eye drops. Timolol Maleate is used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases. Lowering high pressure inside the eye helps to prevent blindness.

General Properties and Specifications of Timolol Maleate as pe IP:
Appearance: A white or almost white crystals or powder.
Assay: 98.5% to 101% C13H24N4O3S-C4H4O4.
Identification: IR.
Appearance of the solution: a 2% solution in water is clear and not more intensely colored than the reference solution.
pH: 3.8 to 4.3 in 2% solution.
Specific optical rotation: -5.7 to -6.2
Enantiomeric purity: by HPLC: Impurity A: NMT 1.0%
Related substances:
Impurity B: NMT 0.1%
Impurity C: NMT 0.1%
Impurity D: NMT 0.1%
Impurity F: NMT 0.1%
Individual unspecified impurity: NMT 0.1%
Total Impurities: NMT 0.4%
Sulfated Ash: NMT 0.1%
Loss on drying at 105C for 3h: NMT 0.5%
Residual Solvent:
Acetone: NMT 1000 ppm.
Methylene Chloride: NMT 500 ppm.
tert-Butanol: NMT 500 ppm.
Benzene: NMT 2 ppm.
Melting Point: 198C literature.
Solubility: Soluble in water and methanol, ethanol (96%). Sparingly soluble in chloroform.
Storage: Room temperature. Preferably refrigerate.

Timolol Maleate USP Grade Specifications:
C13H24N4O3S-C4H4O4 --- 432.49
2-Propanol, 1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-, (S)-, (Z)-2-butenedioate (1:1) (salt);
(−)-1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt) CAS 26921-17-5
UNII: P8Y54F701R
UNII: 5JKY92S7BR

DEFINITION
Timolol Maleate contains NLT 98.0% and NMT 102.0% of timolol maleate (C13H24N4O3S-C4H4O4), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption
B. Ultraviolet Absorption
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: To pass the test.
Optical Rotation, Specific Rotation:
Sample solution: 50 mg/mL of Timolol Maleate in 1.0 N hydrochloric acid.
Acceptance criteria: −11.7° to −12.5° (λ = 405 nm)
pH: For 20 mg/mL of Timolol Maleate in water. Acceptance criteria: 3.8–4.3
Loss on Drying: Dry under vacuum at 100C to constant weight. Acceptance criteria: NMT 0.5%

DEFINITION
(2S)-1-[(1,1-Dimethylethyl)amino]-3-[[4-(morpholin-4-yl)-1,2,5-thiadiazol-3-yl]oxy]propan-2-ol (Z)-butenedioate.
Content: 98.5 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder or colourless crystals.
Solubility: Soluble in water and in ethanol (96 per cent).
mp: about 199C, with decomposition.

IDENTIFICATION
First identification: A, B
Second identification: A, C, D
A. Specific optical rotation: -6.2 to -5.7.
Dissolve 1.000 g in 1 M hydrochloric acid and dilute to 10.0 mL with the same acid.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography.
D. To pass the test.

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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Timolol Maleate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 25-Jan-24

Product Name & Other Names: Timolol Maleate.
CAS Number: 26921-17-5 or 60469-65-0
EINECS EC Number: 248-111-5
Molecular Weight: 432.49
Chemical Formula: C13H24N4O3S-C4H4O4 or C17H28N4O7S
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

Hazard Statements:
H302: Harmful if swallowed.
H361: Suspected of damaging fertility or the unborn child.

Precautionary Statements:
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contaminated parts thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P301+P310: IF SWALLOWED: Immediately call a POSION CENTER or doctor/physician.
P314: Get medical advice/attention if you feel unwell.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P302+352: IF ON SKIN: Wash with plenty of soap and water.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
P308+P313: IF exposed or concerned: Get medical advice/ attention.
P360: Rinse immediately contaminated clothing and skin with plenty of water before removing clothes.
P403+P404: Store in well-ventilated place. Keep container tightly closed.
P501: Dispose of contents/container in accordance with local/national regulation.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn Harmful.
Xi Irritant.
Risk Phrases:
R22 Harmful if swallowed.
R61 May cause harm to the unborn child.

Product Name & Other Names: Timolol Maleate.
CAS Number: 26921-17-5 or 60469-65-0
EINECS EC Number: 248-111-5

Inhalation: Remove affected person to fresh air; if normal breathing has not returned within a few minutes after exposure, get medical attention.
Skin: Remove contaminated clothing; wash affected area with soap and water; launder contaminated clothing before reuse. Seek medical attention.
Eyes: Immediately, flush eyes for 15 minutes in clear running water while holding eyelids open; seek medical attention immediately.
Ingestion: Drink two glasses of water followed by milk, milk of magnesia or other non-alcoholic liquids; Do not induce vomiting; seek medical attention immediately.
Physician may treat symptomatically.

General Hazards: Product will support combustion.
Extinguishing Media: Carbon dioxide, water fog, dry chemical, chemical foam. Keep containers cool by spraying with water. Use extinguishing media appropriate for surrounding fire.
Fire & Explosion Hazard: May evolve oxides of carbon (COx), nitrogen oxides, sulfur oxides and fumes under fire conditions.
In case of fire, wear a full face positive-pressure self-contained breathing apparatus and protective suit. Self - contained respiratory equipment; cool containers to prevent pressure buildup and explosion when exposed to extreme heat. Caution - material will support combustion!
Unusual Fire and Explosion Hazards: Closed containers can explode due to buildup of pressure when exposed to extreme heat.
Hazardous Combustion Products: Products of combustion include nitrogen oxides, sulfur oxides, CO, CO2 and toxic fumes.
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: 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 sewer, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Contain spilled material. 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. Keep containers closed when not in use; protect containers from abuse; protect from extreme temperatures, open flames. This material will support combustion. Room temperature. Preferably refrigerate.

Engineering Controls: The use of local exhaust ventilation is recommended to control emissions near the source. Provide mechanical ventilation of confined spaces. Use corrosion-resistant, explosion-proof ventilation equipment.
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 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.

Appearance: A white or almost white crystals or powder.
Odor: Not available.
Odor threshold: Not available.
pH: 3.8 to 4.3 in 2% solution.
Relative density: Not available.
Melting point/freezing point: 198C literature.
Boiling Point: 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 (MM Hg): Not available.
Vapor Density (Air = 1): Not available.
Evaporation Rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility in Water: Soluble in water and methanol, ethanol (96%). Sparingly soluble in chloroform.
Viscosity: Not available.
Molecular Weight: 432.49
Chemical Formula: C13H24N4O3S-C4H4O4 or C17H28N4O7S

Stability: Stable at recommended temperatures and operating conditions.
Conditions to Avoid: Avoid excessively high temperatures, sunlight, air, and incompatibles.
Incompatibilities: Strong oxidizing agents.
Decomposition: Decomposition yields nitrogen oxides, sulfur oxides, carbon monoxide & dioxide, fumes.
Polymerization: Polymerization will not occur.

Reproduction: Suspected of damaging the unborn child. Suspected of damaging fertility.
Mutagenicity: Not known.
Carcinogenicity: Not listed as a human carcinogen by OSHA, IARC, ACGIH & NTP.
Acute Oral Effects: Oral LD50 – Rats 1028 mg/kg.
Acute Dermal Toxicity: LD50 Dermal - Rat - 3129 mg/kg.

Toxicity to fresh-water fish: Not available.
Persistence and accumulation: Not available.
Mobility: Not available.

Dispose in accordance with Local, State, and Federal Regulations. Consult local, state, or Federal Environmental Protection Agency before disposing of any chemicals.

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

UNITED STATES REGULATORY INFORMATION
SARA 311/312 Hazard Categories: See section 2 for more information.

European Labeling in Accordance with EC Directives:
H302: Harmful if swallowed.
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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