Mirtazapine is an antidepressant. The way this medication works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain.

Mirtazapine is used to treat major depressive disorder. Mirtazapine may also be used for purposes not listed in this medication guide.

Certificate of Analysis

• Description

  White to creamy white; crystalline powder.

  Result

  White crystalline powder.

• Solubility

  Freely soluble in methanol & toluene, soluble in ethyl ether, sparingly soluble in n-Hexane, practically insoluble in water.

  Result

  Freely soluble in methanol & toluene, soluble in ethyl ether, sparingly soluble in n-Hexane, practically insoluble in water.

• Identification by IR

  IR absorption spectrum of the sample KBr dispersion should be concordant with similarly recorded spectrum of Mirtazapine working standard.

  Result

  IR absorption spectrum of the sample KBr dispersion should be concordant with similarly recorded spectrum of Mirtazapine working standard.

• Identification by HPLC

  The Retention time of major peck in the chromatogram of the assay preparation corresponds to that in the chromatogram of standard preparation as obtained in the assay by HPLC method.

  Result

  The Retention time of major peck in the chromatogram of the assay preparation corresponds to that in the chromatogram of standard preparation as obtained in the assay by HPLC method.

• Specific Optical rotation

  +2° to – 2°( On anhydrous basis )

  Result

  0°

• Water Content

  Not more than 3.5 % w/w

  Result

  1.085 %

• Residue on Ignition

  Not more than 0.1 % w/w

  Result

  0.069 %

• Heavy Metals

  Not more than 0.001 %

  Result

  Less than 0.001 %

• Related substances by HPLC
  Result

• Impurity A

  Not more than 0.10 %

  Result

  0.005 %

• Impurity B

  Not more than 0.10 %

  Result

  Not Detected

• Impurity C

  Not more than 0.10 %

  Result

  0.014 %

• Impurity D

  Not more than 0.10 %

  Result

  Not Detected

• Impurity E

  Not more than 0.10 %

  Result

  Not Detected

• Impurity F

  Not more than 0.10 %

  Result

  0.003 %

• Individual unspecified imp.

  Not more than 0.10 %

  Result

  0.045 %

• Total impurities

  Not more than 0.50 %

  Result

  0.122 %

• Assay by HPLC (On anhydrous basis)

  Not more than 98.0 % 99.105 %& Not more than 102.0 %

  Result

  99.105 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Mirtazapine

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Mirtazapine

  Molecular Formula

  C17H19N3

  CAS Number

  61337-67-5

• Section 3 – HAZARDOUS IDENTIFICATION

  Physical Hazards

  Not classfied

  Health Hazards

  Acute Toxicity, Oral Category 4, Specific Target Organ Toxicity, Single Exposure Category 3 Narcotic Effects.

  Osha Hazard(S)

  Not Classified.

  Hazard Statement

  Harmful If Swallowed. May Cause Drowsiness or Dizziness.

  Precautionary Statement

  Use Only Outdoors or in A Well-Ventilated Area. Wash Thoroughly After Handling. Do Not Eat, Drink or Smoke When Using This Product.

  Response

  If Swallowed

  Call A Poison Center/Doctor/Medical Professional/ If You Feel Unwell. Rinse Mouth.

  If Inhaled

  Remove person to fresh air and keep comfortable for breathing. Call a poison Center/Doctor/Medical professional.

• Section 4 – FIRST AID

  Eye Contact

  Rinse with water. get medical attention if irritation develops and persists.

  Inhalation

  Move to fresh air. Call a physician if symptoms develop or persist. Skin contact: rinse skin with water/shower. Get medical attention if irritation develops and persists.

  Ingestion

  Rinse mouth. Get medical attention if symptoms occur. Symptoms/effects, acute and delayed indication of immediate medical attention and special treatment needed provide general supportive measures and treat symptomatically. Do not induce vomiting. Perform gastric lavage. Administer activated charcoal as slurry. Protect airway and support ventilation and perfusion. Monitor cardiac rhythm. Monitor vital signs.

  General Information

  Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider familiar with workplace chemical exposures. In the united states, the national poison control center phone number is 1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention.

• Section 5 – FIRE FIGHTING MEASURES

  Suitable extinguishing media

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

  Unsuitable extinguishing media

  Not known

  Specific hazards arising from the chemical

  No unusual fire or explosion hazards noted

  Special protective equipment and precautions for fire-fighters

  Wear suitable protective equipment.

  Fire-fighting equipment/instructions

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

  Specific methods

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

• Section 6 – ACCIDENT RELEASE MEASURES

  General Information

  Evacuate area. Wear self-contained breathing apparatus, rubber boots and heavy rubber gloves. Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete.

• Section 7 – HANDLING AND STORAGE

  Precautions

  Precautions for safe handling as a general rule, when handling USP reference standards, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surfaces with suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin thoroughly. Conditions for safe storage, including any incompatibilities store in tight container as defined in the USP-NF. This material should be handled and stored per integrity label instructions to ensure product.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  General Information

  Wear appropriate NIOSH/MSHA-approved respirator, chemical-resistant gloves, safety goggles, other protective clothing. Safety shower and eye bath. Use only in a chemical fume hood. Do not breathe dust. Do not get in eyes, on skin, on clothing. Avoid prolonged or repeated exposure. Wash thoroughly after handling. Keep tightly closed. Store at ambient condition place.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Appearance

  White to creamy white crystalline

  Melting Point

  112°C – 124 °

  Solubility

  Freely soluble in methanol & toluene, soluble in ethyl ester, sparingly soluble in n-hexane, partially insoluble in water.

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  The product is stable at normal condition.

• Section 11 – TOXICOLOGICAL INFORMATION

  Routes of Entry

  Harmful if swallowed, inhaled, or absorbed through skin. May cause irritation. Prolonged or repeated exposure may cause shortness of breath. Swelling. Flu symptoms. Mental status changes. Skin rash. Constipation. Dizziness. Drowsiness. Dry mouth. Increased appetite. Weight gain. Abdominal pain. Abnormal