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 thoughts or dreams. Weakness. Back pain. Thirst. Muscle pain. Nausea. Trembling. Increased urination. Vomiting. Disorientation. Fast heartbeat. Exposure can cause: high blood pressure. Low blood pressure. Vertigo.
Section 12 – ECOLOGICAL INFORMATION
No data available.
Section 13 – DISPOSAL CONSIDERATION
Disposal Instructions
This product, in its present state, when discarded or disposed of, is not a hazardous waste according to federal regulations (40 CFR 261.4 (b)(4)). Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria for hazardous waste. Dispose in accordance with all applicable regulations. Waste from residues / unused products: empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: disposal instructions).
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
General Information
Mirtazapine is safe & can be transported by air / sea mode by taking proper precautions as above.
Section 15 – REGULATORY INFORMATION
US Federal Regulations
CERCLA/SARA hazardous substances – not applicable. One or more components are not listed on TSCA. Superfund amendments and reauthorization act of 1986.
(Sara) Hazard Categories
Immediate hazard
Yes
Delayed hazard
No
Fire hazard
No
Pressure hazard
No
Reactivity hazard
No
Sara 302 extremely hazardous substance
No
Sara 311/312 hazardous chemical
No
Section 16 – OTHER INFORMATION
Atilus 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.
ATILUS 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
