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Duloxetine

CAS Number
116539-59-4
EC Number
601-438-0
Chemical Formula
C18H19NOS
Molecular Weight
297.4 g/mol

Description

Duloxetine (CAS 116539-59-4 ), also referenced in development literature as LY248686, is a selective serotonin-norepinephrine reuptake inhibitor (SNRI) active pharmaceutical ingredient used as the core therapeutic compound. It is sourced by pharmaceutical manufacturers as a bulk API for formulation into branded and generic prescription medications. The primary application is in the manufacture of delayed-release oral capsules. These capsules target major depressive disorder, generalized anxiety disorder, and diabetic peripheral neuropathic pain. These are product categories with sustained global generic demand for manufacturers. Contract manufacturers and generic drug developers procure this API to produce enteric-coated pellet formulations. These pellets protect the compound through gastric transit for optimal patient absorption. Specialty pharma companies also incorporate it into combination or modified-release formats under development. Procurement of this API is subject to ICH Q7 GMP compliance requirements for all suppliers. Supplier qualification and documentation are central purchasing considerations for this material. It is supplied as a white to off-white crystalline powder in bulk quantities suited to commercial-scale manufacturing. It is available in hydrochloride salt form, which is the standard pharmaceutical grade used in registered drug products. Certificates of Analysis aligned with USP and EP monograph specifications are standard. These documents are expected by qualified buyers to ensure the highest quality standards are met. This ensures the material is suitable for use in finished-dose antidepressant and pain management drug products. Contact us for supply of Duloxetine Request Quote

Other Names (Synonyms)

(3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine | (S)-Duloxetine | Yentreve | 2-Thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, (gammaS)- | (3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine | methyl[(3S)-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine | O5TNM5N07U

Key Technical Features

  • High Purity Grade standard
  • Consistent Batch Quality
  • Full Regulatory & REACH Support
  • Global Logistics Network enabled

Physical Properties

Boiling Point466.2±40.0 °C(Predicted)
Density1.158±0.06 g/cm3(Predicted)
ColorLight brown to yellow
FormOil

Safety & Handling

Warning
GHS08· Health HazardGHS02· FlammableGHS06· Toxic

Hazard Statements

H225Highly Flammable liquid and vapor
H301Toxic if swallowed
H311Toxic in contact with skin
H331Toxic if inhaled
H351Suspected of causing cancer
H361Suspected of damaging fertility or the unborn child
H370Causes damage to organs

Precautionary Statements

P203Obtain, consult and follow expert instructions for use.
P210Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233Keep container tightly closed.
P240Ground and bond container and receiving equipment.
P241Use explosion-proof equipment.
P242Use non-sparking tools.
P243Take action to prevent static discharges.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P262Do not get in eyes, on skin, or on clothing.
P264Wash … thoroughly after handling.
P270Do not eat, drink or smoke when using this product.
P271Use only outdoors or in a well-ventilated area.
P280Wear protective gloves/protective clothing/eye protection/face protection.
P316Get emergency medical help immediately.
P318IF exposed or concerned, get medical advice.
P321Specific treatment (see … on this label).
P330Rinse mouth.
P405Store locked up.
P501Dispose of contents/container in accordance with local regulations.
P316Get emergency medical help immediately.
P352IF ON SKIN: Wash with plenty of water.
P340IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P316Get emergency medical help immediately.
P364Take off immediately all contaminated clothing and wash it before reuse.
P378Use … for extinction.
P233Store in a well-ventilated place. Keep container tightly closed.
P235Store in a well-ventilated place. Keep cool.
P353IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.