Paroxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may be unbalanced in people with depression, anxiety, or other disorders.

Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

The Brisdelle brand of paroxetine is used to treat hot flashes related to menopause. Brisdelle is not for treating any other conditions.

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

Certificate of Analysis

• Description

  White or off white solid.

  Result

  White solid.

• Solution

  Soluble in methanol & alcohol. Slightly soluble in water.

  Result

  Complies.

• Identification by IR

  The Infrared absorption spectrum sample is concordant with the standard spectrum of Paroxetine hydrochloride working standard.

  Result

  Complies

• Identification by Chloride

  Precipitate of silver chloride should be observed.

  Result

  Complies.

• Water content by KF

  Not more than 2.2 to 2.8 % w/w.(For hemihydrate form)

  Result

  2.35 %

• Heavy Metals

  Not more than 20 ppm.

  Result

  Less than 20 ppm.

• Residue on Ignition

  Not more than 0.1 %

  Result

  0.05 %

• Paroxetine related compound – C

  Not more than 0.1 %

  Result

  0.07 %

• Paroxetine related compound – E

  Not more than 0.0001 %

  Result

  Not detected.

• Chromatography purity by HPLC Method – II
  Result

• Paroxetine related compound – B

  Not more than 0.5 %

  Result

  0.20 %

• Paroxetine related compound – F

  Not more than 0.2 %

  Result

  0.07 %

• Paroxetine related compound – G

  Not more than 0.2 %

  Result

  Not detected.

• Highest unspecified impurity

  Not more than 0.1 %

  Result

  0.03 %

• Total impurities

  Not more than 1.0 %

  Result

  0.30 %

• Assay by HPLC

  NLT 98.5 % & NMT 102.0 % w/w.(On anhydrous basis)

  Result

  99.90 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Paroxetine HCL

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Paroxetine Hydrochloride

  Synonym

  Piperidine,3-[(1,3-benzodioxol-5-yloxy)methyl]-4-94-flourophenyl)-,(3S-trans)-,hydrochloride, hemihydrate with 1-methyl-4-(p-flourophenyl)-1,2,3,6- tetrahydropyridine.

  Molecular Formula

  C19H21CIFNO3, 1/2H2O

  Molecular Weight

  374.84

  CAS Number

  110429-35-1

• Section 3 – HAZARDOUS IDENTIFICATION

  General Information

  This product is supplied in a small quantity which does not constitute a combustible dust hazards. The physical properties of this material indicate that in large quantities accumulated dust maybe non-hazardous.

  Physical hazards

  Not classified

  Health hazards

  Acute toxicity, oral category 4

  OSHA hazards

  Not classified

  Hazards Statement

  Harmful if swallowed. Causes serious eye damage. May damage fertility or the unborn child.

  Precautionary statement prevention

  Obtain special instruction before use. Do not handle until all safety precautions have been read & understood. Wash thoroughly after handling. Do not eat, drink or smoke when using this product. Wear protective gloves / protective clothing/eye protective/face protective.

  Potential Health Effects

  Eyes

  Rinse cautiously with water for several minutes; Remove contact lenses, if professional, if exposed or concerned. Get medical advice/ attention.

  Ingestion

  Call a poison center/doctor/medical professional/if you fell unwell.

• Section 4 – FIRST AID

  Skin Contact

  Rinse skin with water/shower. Get medical attention if irritation develops & persists.

  Eye Contact

  Rinse cautiously with water for several minutes. Remove contact lenses, If present & easy to do. Continue rinsing. Call a Physician or poison control center immediately

  Inhalation

  Move to fresh air, call a physician if symptoms develop or persist.

  Ingestion

  Rinse mouth. If swallowed: call a poison center or doctor/physician if you fell unwell.

• Section 5 – FIRE FIGHTING MEASURES

  Suitable extinguishing media

  Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire & materials.

  Unsuitable extinguishing media

  None known.

  Specific hazards arising from the Chemical

  Explosion hazards

  Avoid generating dust; fine dust dispersed in air in sufficient concentrations & in the presence of an ignition source is a potential dust explosion hazards.

  Special protective equipment & precautions for fire-fightersWear suitable protective equipment.Fire-fighting equipment/instructions

  As with all fires, evacuate personnel to a safe area. Firefighting should use self-contained breathing equipment & protective clothing.

  Specific methods

  Cool containers exposed to flames with water until well after the fire is out.

• Section 6 – ACCIDENT RELEASE MEASURES

  Protective equipment & procedures

  Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration. Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriates protective clothing. Avoid inhalation of dust from the spilled material. Ensure adequate ventilation. Wear appropriate personal protective equipment.

  Clean-up methods

  Sweep up or vacuum up spillage & collect in suitable container for disposal. Avoid the generation of dusts during clean-up.

• Section 7 – HANDLING AND STORAGE

  Handling

  Combustible dust clouds may be created where operations produce fine material (dust). Avoid significant deposits of material, especially on horizontal surfaces, which may become airborne & form combustible dust clouds & may contribute to secondary explosions. As a general rule, when handling USP reference standards, avoid & inhalation of dust, mists, & /or vapors associated with material. Clean equipment & work surfaces with suitable detergent or solvent after use. After removing gloves, wash hands & other exposed skin thoroughly.

  Storage

  Preserve the Hemihydrate form in well-closed container. Store at controlled room temperature.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally preferred to general exhaust because it can control the contaminant as its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the effectiveness of engineering controls. Effectiveness of engineering controls intended for use with highly potent materials should be assessed by use of nontoxic surrogate materials. Avoid any open handling of this material, particularly for grinding, crushing, weighting, or other dust-generating or aerosol-generating procedures. Use a laboratory fume hood, vented enclosure, glove box, or other effective containment.

  Personnel Protective Equipment

  Eyes

  Safety glasses with slid shields are recommended. Face shields or goggles may be required.

  Skin

  N/A

  Clothing

  For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significant quantities are handled, work clothing may be necessary to prevent take home contamination.

  Respirators

  Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection & have an effective respirator program in place.

  Thermal hazards

  N/A

  General Considerations

  Handle in accordance with good industrial hygiene & safety practice.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Appearance

  White to off-white crystalline powder.

  Physical State

  Solid

  Form

  Powder

  Odor

  Odorless

  pH

  6 -7 (aqueous solution)

  Melting point / Freezing Point

  248 – 293° F(120-145° C)

  Initial Boiling point & boiling range

  N/A

  Flash Point

  N/A

  Evaporation rate

  N/A

  Flammability (solid, gas)

  N/A

  Flammability Limit-lower (%)

  N/A

  Flammability Limit-upper (%)

  N/A

  Explosive limits- lower (%)

  N/A

  Explosive limits- upper (%)

  N/A

  Vapour Pressure

  N/A

  Vapour density

  N/A

  Relative density

  N/A

  Solubility in water

  Slightly soluble

  Partition coefficient (n-octanol/water)

  1.3 (pH 7)

  Auto-ignition temperature

  N/A

  Decomposition temperature

  N/A

  Viscosity

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Reactivity

  No reactivity hazards known.

  Chemical Stability

  Stable at normal conditions.

  Possibility of hazardous reactions

  No dangerous reaction known under conditions of normal use.

  Conditions to avoid

  None known.

  Hazardous decomposition products

  NOx, CI-, F- Irritating & / or toxic fumes or gases. Emits toxic fumes under fire conditions.

  Incompatibility Materials

  Strong oxidizing agents, strong bases.

• Section 11 – TOXICOLOGICAL INFORMATION

  Ingestion

  Harmful if swallowed.

  Inhalation

  Due to lack of data the classification is not possible.

  Skin Contact

  Due to lack of data the classification is not possible.

  Eye contact

  Causes serious eye damage.

  Acute toxicity

  Harmful if swallowed.

  Skin corrosion / irritation

  Based on available data, the classification criteria are not met.

  Serious eye damage / eye irritation

  Causes serious eye damage.

  Respiratory sensitization

  Due to lack of data the classification is not possible.

  Skin sensitization

  Based on available data, the classification criteria are not met.

  Sensitization

  Guinea pig maximization assay.

  Carcinogenicity

  Based on available data, the classification criteria are not met. This product is not considered to be a carcinogen by IARC, ACGIH, NTP, OR OSHA. 20 MG/KG/DAY Long term carcinogenicity studies.

  Reproductive toxicity

  May damage fertility or the unborn child. Epidemiological studies have shown an association between therapeutic use of Paroxetine in the first trimester & an increased risk of congenital malformations, particularly cardiac defects, in the newborn.

  Species

  Reproductively

  15 mg/kg/day Toxicity study.

  Rat

  25 – 50 mg/kg/day Toxicity study

• Section 12 – ECOLOGICAL INFORMATION

  Persistence & degradability

  Not readily biodegradable.

  Bioaccumulative potential

  N/A

  Mobility in soil

  N/A

  Other adverse effects

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Dispose of contents/container in accordance with local / regional / state / national / international regulations.

  Unused Products

  Empty containers or liners may retain some product residues. This material & its container must be disposed of in a safe manner.

  Contaminated Packaging

  Empty containers should be taken to an approved waste handling site for recycling or disposal. Since emptied containers may retain product residue, follow label warnings even after container is emptied.

• Section 14 – TRANSPORT INFORMATION

  UN Proper Shipping Name

  Environmentally no hazardous substance, solid.

  Transport Hazard Class

  N/A

  Subsidiary Class

  N/A

  Packing Group

  N/A

• Section 15 – REGULATORY INFORMATION

  Safety, health & environmental regulations / legislation specific for the substances or mixture

  N/A

  Chemical safety assessment

  N/A

• 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.