Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.

Duloxetine is used to treat major depressive disorder in adults. Duloxetine is also used to treat general anxiety disorder in adults and children who are at least 7 years old.

Duloxetine is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

Duloxetine is also used to treat pain caused by nerve damage in adults with diabetes (diabetic neuropathy).

Duloxetine may also be used for purposes not listed in this medication guide.

Certificate of Analysis

• Description

  White or almost white, crystalline powder, odourless or almost odourless.

  Result

  White or almost white, crystalline powder, odourless.

• Solubility

  Freely soluble in ethanol (95 %) & chloroform; soluble in water, practically insoluble in ether.

  Result

  Complies

• Identification

  A, B, C, &D Complies/Does not complies.

  Result

  Complies / M.P. : 170° C

• Related substance

  Solution(1)is not more intense than the spot in the chromatogram obtained with solution(2)

  Result

  Complies

• Sulphated Ash

  NMT – 0.1 %

  Result

  0.03 %

• Loss on drying

  NMT – 1.0 %

  Result

  0.12 %

• Assay

  N99.0 % TO 101 %

  Result

  100.32 % (O.D.B)

Note: Note: – We are leading channel partner of much API manufacturer, supplier & exporters and Pharmaceutical raw material in Colombo, Chili, Ecuador and Globally.

Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Duloxetine Hydrochloride

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Duloxetine Hydrochloride

  Synonym

  (+) N-Methyl-3-(1naphthalenyloxy-3- (2thienyl) propanamine Hydrochloride

  Molecular Formula

  C18H19FNOSHCI

  Molecular Weight

  333.9

  CAS Number

  135434-34-9

• Section 3 – HAZARDOUS IDENTIFICATION

  Emergency Overview

  Irritating to eyes, respiratory system and skin.

  Potential Health effects

  Eyes

  Causes eye irritation

  Skin

  Causes skin irritation. May be harmful, if absorbed through skin

  Ingestion

  May cause irritation of the digestive tract. May be harmful if swallowed.

  Inhalation

  May cause respiratory tract irritation. May be harmful, if inhaled.

  Chronic

  N/A

• Section 4 – FIRST AID

  Skin Contact

  Wipe off excess material from skin then immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes, Get medical attention immediately. Wash clothing & shoes thoroughly before reuse.

  Eye Contact

  Immediately flush eyes with plenty of water for at least 15 minutes lifting lower and upper eyelids occasionally. Get medical aid.

  Inhalation

  Remove to fresh air. Get medical attention immediately.

  Ingestion

  If swallowed, INDUCE VOMITING. Give large quantities of water. Never give anything by mouth to an unconscious person. Get medical attention immediately.

• Section 5 – FIRE FIGHTING MEASURES

  General Information

  As in any fire, wear a self-contained breathing apparatus in pressure-demand, and full protective wear.

  Extinguishing Media

  Use water spray, dry chemical, carbon dioxide or chemical foam.

• Section 6 – ACCIDENT RELEASE MEASURES

  General Information

  Use proper protective equipment as indicated in section-8.

  Spills / Leaks

  Ventilate area of spill. Isolate hazard area. Keep away unnecessary and unprotected personal from entering. Flush with water. Use wet mop and vacuum to pick up spilled product. Dispose the collected powder and washings as per local laws.

• Section 7 – HANDLING AND STORAGE

  Handling

  Avoid breathing powder, vapor, mist., or gas. Avoid contact with skin & eyes.

  Storage

  Store in well closed containers.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Facilities storing or utilizing this material should be equipped with an eye was facility and a safety shower. Use adequate ventilations to keep airborne concentrations low.

  Personnel Protective Equipment

  Splash goggles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

  Personal Protection in Case of a Large Spill

  Eyes

  Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA`s eye and face protection regulations.

  Skin

  Wear appropriate protective gloves to prevent skin exposure.

  Clothing

  Wear appropriate protective clothing to prevent skin exposure.

  Respirators

  Follow the respirators regulations.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  Powder

  Color

  An off white to white colored Powder

  Odor

  N/A

  pH

  N/A

  Viscosity

  N/A

  Boiling Point

  N/A

  Auto ignition temperature

  N/A

  Flash Point

  N/A

  Explosion Limit, Lower

  N/A

  Explosion Limit, Higher

  N/A

  Decomposition temperature

  N/A

  Freezing / Melting Point

  N/A

  Specific Gravity / Density

  1.34 (Water = 1)

  Vapor Pressure

  N/A

  Vapor Pressure

  N/A

  Assay

  98%(+)

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable at Room temperature in closed containers under normal storage and humidity conditions.

  Conditions to avoid

  Incompatible materials

  Incompatibility with others

  Strong oxidizing agents

  Hazardous decomposition products

  Hydrogen bromide, Nitrogen oxides, Carbon monoxide

  Hazardous polymerization

  Has not been reported

• Section 11 – TOXICOLOGICAL INFORMATION

  To the best of our knowledge the toxicological properties have not been thoroughly investigated. However, harmful if swallowed in large amount., causes irritation if it contacts with eyes.

• Section 12 – ECOLOGICAL INFORMATION

  Data Not Available.

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  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 off container and unused contents in accordance with federal, state and local requirements

• Section 14 – TRANSPORT INFORMATION

  IATA Non-hazardous for transport.

• Section 15 – REGULATORY INFORMATION

  European / international regulations

  European labeling in accordance with EC Directives

  Hazard symbols

  N/A

  Risk

  Irritating to eyes, respiratory systems and skin.

  Safety phrases

  In case of contact with eyes, rinse immediately with plenty of water & seek medical advice

• Section 16 – OTHER INFORMATION

  Global Pharma provides information contained herein in good faith but makes no representation as to its comprehensives or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product.

  Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

  GLOBAL PHARMA MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OR MERCHANTABILITY, FITNESS FOR A PARTICULER PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT WHICH THE INFORMATION REEFERS. GLOBAL PHARMA WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF RELIANCE UPON THIS INFORMATION