CAS Number 171596-29-5, Tadalafil BP Ph Eur EP USP Grade Manufacturers Exporters
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CAS Number 171596-29-5, Tadalafil BP Ph Eur EP USP Manufacturer Exporter
For Properties Specifications of Tadalafil Click Properties, Specifications of Tadalafil Manufacturer.
For Uses of Tadalafil Click Uses of Tadalafil Manufacturer.
For For SDS MSDS Sheet of Tadalafil Click SDS Safety Data Sheet MSDS Sheet of Tadalafil Manufacturer.
The Properties and Specifications of Tadalafil:
Tadalafil BP Ph Eur Grade Specifications:
C22H19N3O4 --- 389.4 CAS 171596-29-5
Action and use: Selective inhibitor of cyclic GMP-specific phosphodiesterase (Type V) with vasodilator action; treatment of erectile dysfunction.
DEFINITION
(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1′,2′:1,6]-pyrido[3,4-b]indole-1,4-dione.
Content: 97.5 per cent to 102.0 per cent (dried substance).
CHARACTERS
Appearance: White or almost white powder.
Solubility: Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride.
IDENTIFICATION
Carry out either tests A, B or tests A, C.
A. Infrared absorption spectrophotometry.
B. Liquid chromatography: to pass the test.
C. Specific optical rotation: + 78.0 to + 84.0 (dried substance).
Dissolve 0.250 g in dimethyl sulfoxide and dilute to 25.0 mL with the same solvent.
TESTS
Impurities A, B and C: To pass the test by Liquid chromatography.
Related substances: To pass the test by Liquid chromatography.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 105C for 3 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Tadalafil USP Grade Specifications:
C22H19N3O4 --- 389.40
Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R -12aR )-;
(6R ,12aR )-2,3,6,7,12,12a-Hexahydro-2-methyl-6-[3,4-(methylenedioxy)phenyl] pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione CAS 71596-29-5
UNII: 742SXX0ICT
DEFINITION
Tadalafil contains NLT 97.5% and NMT 102.5% of tadalafil (C22H19N3O4 ), calculated on the dried basis.
IDENTIFICATION
A. Infrared Absorption.
B. The retention time of the major peak of the Sample solution corresponds to that of the Identification solution, as obtained in the test for Enantiomeric and Diastereomeric Purity.
Residue on Ignition: NMT 0.10%, using a 1-g sample
Organic Impurities: To pass the test by chromatography.
Enantiomeric and Diastereomeric Purity: To pass the test.
Loss on Drying: Dry a sample under vacuum at 105C for 3 h. Acceptance criteria NMT 0.5%
We also manufacture Tadalafil EP Grade.
The Uses of Tadalafil:
Tadalafil used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.
The MSDS-SDS Hazard Statement of Tadalafil:
Tadalafil or Tadanafil SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 13-Nov-24
1. Product Identification
Product Name & Other Names: Tadalafil or Tadanafil.
CAS No.: 171596-29-5
EINECS, EC Number: 687-782-2
Relevant uses and uses advised against (if any): Industrial Manufacturing.
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
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
Labelling according to GHS & Regulation (EC) No 1272/2008
GHS Label Elements  Irritant |
Signal Words: Warning
Hazard statements:
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.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P302+P352-IF ON SKIN: Wash with plenty of soap and water.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+351+338: 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.
3. Composition/Information on Ingredients
Product Name & Other Names: Tadalafil or Tadanafil.
CAS No.: 171596-29-5
EINECS, EC Number: 687-782-2
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: Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Wipe off excess material from skin then immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.
5. Fire Fighting Measures
Flammability of the Product: Combustible at high temperature.
Products of Combustion: Nitrogen oxides, Carbon dioxide, Carbon monoxide, fumes.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Avoid heavy water jets. Use any means suitable for extinguishing surrounding fire. Avoid solid water jet as it can scatter the fire.
Special Information: Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place. 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.
6. Accidental Release Measures
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:
Small Spill: Avoid dust formation. Avoid breathing dust. Ensure adequate ventilation. Use appropriate tools to put the spilled solid in a convenient waste disposal container.
Large Spill: 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.
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. 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: Room Temperature.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: Not Established.
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. Wash hands after handling.
9. Physical and Chemical Properties
Appearance: White to Light yellow powder to crystal. Air Sensitive, Heat Sensitive.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: 1.5 predicted.
Melting Point: 301C - 302C 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: Very slightly soluble in water. Soluble in DMF and DMSO.
Viscosity: No data found.
10. Stability and Reactivity
Stability: Stable under recommended conditions of use and storage. Air Sensitive, Heat Sensitive.
Hazardous Decomposition Products: It emits Oxides of Nitrogen, Carbon dioxide, Carbon monoxide & Fumes.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Incompatibles, heat & direct sunlight.
11. Toxicological Information
Toxicity data: No data found.
Carcinogenic Effects: 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.
Reproductive toxicity: No data found.
Germ cell mutagenicity: No data found.
12. Ecological Information
Environmental Fate: No data found.
Environmental Toxicity: No data found.
Persistence and degradability: No data found.
Bioaccumulative potential: No data found.
Mobility in soil: No data found.
Results of PBT and vPvB assessment: No data found.
13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IATA: Not dangerous goods.
IMDG/IMO: Not dangerous goods.
15. Regulatory Information
USA:
SARA 311/312 Hazards: See section 2.
California prop. 65: Not listed.
Section 16 - Additional 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.
Tadalafil Structure
CAS Number 171596-29-5, Tadalafil 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. 13-nov-24
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