Metoclopramide is a medication used mostly for stomach and esophageal problems.It is commonly used to treat and prevent nausea and vomiting, to help with emptying of the stomach in people with delayed stomach emptying, and to help with gastroesophageal reflux disease. It is also used to treat migraine headaches.

Certificate of Analysis

• Description

  White or almost white crystalline powder or crystals.

  Result

  White crystalline powder.

• Solubility

  Very soluble in water, Freely soluble in alcohol, sparingly soluble in methylene chloride.

  Result

  Complies

• Melting Point

  Should melts at about 183° C with decomposition.

  Result

  Complies

• Clarity & colour of solution

  10 % solution is clear & colourless.

  Result

  Complies

• Identification By pH

  First Identification Test A,B,D

  Result

  Complies

• Identification By IR

  Second Identification Test A,C,D,E

  Result

  Complies

• Identification By TLC

  4.50 to 6.00

  Result

  5.21

• Identification By Test of chloride

  Should respond to the chloride

  Result

  Complies

• Identification By Test of primary Aromatic Amines

  Should respond to primary Aromatic Amines

  Result

  Complies

• Heavy Meals

  Not more than 20 ppm

  Result

  Complies

• Sulphated ash

  Not more than 0.1 % w/w

  Result

  0.05 %

• Water

  Between 4.5% to 5.5% w/w

  Result

  5.08 %

• Related Substance by TLC

  Should Comply

  Result

  Complies

• Assay

  Not less than 99.0 %, Not more than 101.0 % Calculated on anhydrous basis.

  Result

  99.81 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Metoclopramide HCL

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Metoclopramide Hydrochloride

  Synonym

  4-Amino-5-chloro-N-[(2-diethylamino)ethyl]-2-methoxybenzamide hydrochloride

  Molecular Formula

  C14H22ClN3O2.HCl.H2O

  Molecular Weight

  362.48 g/mole

  CAS Number

  54143-57-6

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Acute Health Effects:

  Very hazardous in case of skin contact (irritant), of ingestion, of inhalation. Hazardous in case of eye contact (irritant).

  Potential Chronic Health Effects

  Very hazardous in case of skin contact (irritant), of ingestion, of inhalation. Hazardous in case of eye contact (irritant).

  Carcinogenic Effects

  N/A

  Mutagenic Effects

  N/A

  Teratogenic Effects

  N/A

  Developmental Toxicity

  N/A. The substance is toxic to the nervous system. Repeated or prolonged exposure to the substance can produce target organs damage.

• Section 4 – FIRST AID

  Skin Contact

  After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing.

  Serious Skin Contact

  Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention.

  Eye Contact

  Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention.

  Inhalation

  Allow the victim to rest in a well ventilated area. Seek immediate medical attention.

  Serious Inhalation

  N/A

  Ingestion

  Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

  Serious Ingestion

  N/A

• Section 5 – FIRE FIGHTING MEASURES

  Flammability of the Product

  May be combustible at high temperature.

  Auto-ignition Temperature

  N/A

  Flash Points

  N/A

  Flammable Limits

  N/A

  Products of Combustion

  These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2…), halogenated compounds.

  Fire Hazards in Presence of Various Substances

  N/A

  Explosion Hazards in Presence of Various Substances

  Risks of explosion of the product in presence of mechanical impact

  N/A

  Fire Fighting Media and Instructions

  Small Fire

  Use DRY chemical powder.

  Large Fire

  Use water spray, fog or foam. Do not use water jet.

  Special Remarks on Fire Hazards

  N/A

  Special Remarks on Explosion Hazards

  N/A

• Section 6 – ACCIDENT RELEASE MEASURES

  Small Spills

  Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.

  Large Spills

  Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system.

• Section 7 – HANDLING AND STORAGE

  Precautions

  Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust. Wear suitable protective clothing In case of insufficient ventilation, wear suitable respiratory equipment If you feel unwell, seek medical attention and show the label when possible. Avoid contact with skin and eyes Keep away from incompatibles such as oxidizing agents.

  Storage

  Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heat and away from strong oxidizing agents.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

  Personal Protection

  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

  Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self-contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

  Exposure Limits

  N/A

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Odor

  Odorless

  Taste

  N/A

  Colour

  White to yellowish

  pH

  N/A

  Boiling Point

  Decomposes

  Melting Point

  183°C (361.4°F)

  Critical Temperature

  N/A

  Specific Gravity

  N/A

  Vapor Pressure

  N/A

  Vapor Density

  N/A

  Volatility

  N/A

  Odor Threshold

  N/A

  Water/Oil Dist. Coeff

  N/A

  Ionicity (in Water)

  N/A

  Dispersion Properties

  See solubility in water, methanol.

  Solubility

  Partially soluble in cold water, hot water, methanol.

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  The product is stable.

  Incompatible materials

  N/A

  Instability

  N/A

  Incompatibility with various substances

  Reactive with oxidizing agents

  Corrosivity

  N/A

  Special Remarks on Reactivity

  N/A

  Special Remarks on Corrosivity

  N/A

  Polymerization

  N/A

• Section 11 – TOXICOLOGICAL INFORMATION

  Routes of Entry

  Toxicity to Animals

  LD50 / LC 50

  N/A

  Chronic Effects on Humans

  The substance is toxic to the nervous system.

  Other Toxic Effects on Humans

  Very hazardous in case of skin contact (irritant), of ingestion, of inhalation.

  Special Remarks on Toxicity to Animals

  N/A

  Special Remarks on Chronic Effects on Humans

  N/A

  Special Remarks on other Toxic Effects on Humans

  N/A

• Section 12 – ECOLOGICAL INFORMATION

  Ecotoxicity

  N/A

  BOD5 and COD

  N/A

  Products of Biodegradation

  Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

  Toxicity of the Products of Biodegradation

  The products of degradation are more toxic.

  Special Remarks on the Products of Biodegradation

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  No data available

• Section 14 – TRANSPORT INFORMATION

  DOT Classification

  Not a DOT controlled material (United States).

  Identification

  N/A

  Special Provisions for Transport

  N/A

• Section 15 – REGULATORY INFORMATION

  Federal and State Regulations

  No products were found

  Other Regulations:

  OSHA

  Hazardous by definition of Hazard Communications Standard (29 CFR 1910.1200). .

  Other Classifications

  WHMIS (Canada)

  CLASS D-2B: Material causing other toxic effects (TOXIC).

  DSCL (EEC)

  R36/38- Irritating to eyes and skin.

  HMIS (U.S.A)

  Health Hazard

  2

  Fire Hazard

  1

  Reactivity

  0

  Personal Protection

  E

  National Fire Protection Association (U.S.A)

  Health

  2

  Flammability

  1

  Reactivity

  0

  Protective Equipment

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

• 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.