Glimepiride is an oral diabetes medicine that helps control blood sugar levels.

Glimepiride is used together with diet and exercise to treat type 2 diabetes. Insulin or other diabetes medicines are sometimes used in combination with glimepiride if needed.

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

Certificate of Analysis

• Description

  A white or almost white. crystalline Powder.

  Result

  Complies

• Solubility

  Practically insoluble in water, soluble in diethyl form amide. Slightly Soluble in Methylene chloride. Very Slightly soluble in methanol.

  Result

  Complies

• Identification by IR

  To comply

  Result

  Complies

• Related substances by HPLC

  Result

• Impurity B

  NMT 0.4 %

  Result

  Passes

• Impurity C2

  NMT 0.1%

  Result

  Passes

• Impurity D3

  NMT 0.2%

  Result

  Passes

• Impurity A

  NMT 0.5%

  Result

  Passes

• Unknown Impurity

  NMT 0.1%

  Result

  Passes

• Overall Impurities

  NMT 0.5% (Expect Impurity B1,A)

  Result

  0.054 %

• Water by KF

  NMT 0.5 %

  Result

  Passes

• Residue on ignition

  NMT 0.2 %

  Result

  Passes

• Heavy Metals

  NMT 10 PPM

  Result

  Passes

• Assay By HPLC

  98.0 %To 102.0 %

  Result

  Passes

• Particle size by particle size analyser (Malvern)

  Less than 10 micron minimum 90 %

  Result

  Passes

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Glimepiride

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Glimepiride

  Synonym

  HOE 490

  Molecular Formula

  C24H34N4O5S

  Molecular Weight

  360.8 AMU

  CAS Number

  93479-97-1

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Health effects

  Special Indication of Hazards to Humans Mans and the Environment.Not hazardous according to Directive 67/548/EEC.

• Section 4 – FIRST AID

  Skin Contact

  In case of contact, immediately wash skin with soap and copious amounts of water.

  Eye Contact

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

  Inhalation

  If inhaled, remove to fresh air. If breathing becomes difficult, call a physician.

  Ingestion

  If swallowed, wash out mouth with water provided person is conscious. Call a physician.

  Notes to Physician

  Treat symptomatically and supportively.

• Section 5 – FIRE FIGHTING MEASURES

  Extinguishing Media Suitable

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

  Special Hazards

  Emits toxic fumes under fire conditions.

  Special Protective Equipment for Firefighters

  Special Protective Equipment for Firefighters: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.

• Section 6 – ACCIDENT RELEASE MEASURES

  Procedure(S) of Personal Precaution(S)

  Exercise appropriate precautions to minimize direct contact with skin or eyes and prevent inhalation of dust.

  Methods for Cleaning up

  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

  Handling

  Avoid inhalation. Avoid contact with Skin, Eyes and clothing. Avoid prolonged or repeated exposures.

  Storage

  Keep tightly closed.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Safety showers and eye bath. Mechanical exhaust required.

  General Hygiene Method

  Wash thoroughly after handling.

  Personal Protective Equipment

  Respiratory Protection: Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Respiratory protection is not required. Where protection from nuisance levels of dusts are desired, use type N95 (US) or type P1 (EN 143) dust masks.

  Hand Protection

  Protective gloves

  Eye Protection

  Chemical safety goggles

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Appearance and physical State

  Solid

  Property

  Value at Temperature or Pressure

  pH

  N/A

  Boiling Point

  N/A

  Melting Point

  198-203ºC

  Flash Point

  N/A

  Flammability

  N/A

  Auto ignition Temp

  N/A

  Oxidizing Properties

  N/A

  Explosive Properties

  N/A

  Explosion Limits

  N/A

  Vapor Pressure

  N/A

  SG/Density

  N/A

  Partition Coefficient

  N/A

  Viscosity

  N/A

  Vapor Density

  N/A

  Volatile Component

  N/A

  Saturated Vapor Conc

  N/A

  Evaporation Rate

  N/A

  Bulk Density

  0.25 gm /ml to 0.45 gm/ ml

  Decomposition Temp

  N/A

  Solvent Content

  N/A

  Water Content

  NMT 1.0%

  Surface Tension

  N/A

  Conductivity

  N/A

  Miscellaneous Data

  N/A

  Solubility

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable

  Material to Avoid

  Strong oxidizing agents

  Hazardous Decomposition Products

  CCarbon monoxide, Carbon dioxide, Nitrogen oxides, Sulfur oxides.

  Polymerization

  Will not occur.

• Section 11 – TOXICOLOGICAL INFORMATION

  RTECS NUMBER

  UX9363950

  Signs and Symptoms of Exposure

  To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated

  Route of Exposures

  Skin Contact

  May cause skin irritation

  Skin Absorption

  May be harmful if absorbed through the skin.

  Eye Contact

  May cause eye irritation.

  Inhalation

  May be harmful if inhaled. Material may be irritating to mucous membranes and upper respiratory tract.

  Ingestion

  Harmful is swallowed.

  Chronic Exposure – Reproductive Hazard

  Species

  Rabbit

  Dose

  254 UG/KG 254 UG/KG

  Route of Application

  Oral

  Exposure Time

  (7-18D PREG) (7-18D PREG)

  Result

  Effects on Fertility

  Other measures of fertility. Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants).Abortion

• Section 12 – ECOLOGICAL INFORMATION

  Data Not available.

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations.

• Section 14 – TRANSPORT INFORMATION

  RID/ADR

  Non-Hazard for Road Transport

  IMDG

  Non-Hazard for Sea Transport

  IATA

  Non-Hazard for Air Transport

• Section 15 – REGULATORY INFORMATION

   

  Not hazardous according to Directive 67/548/EEC.

  Caution

  Substance not yet fully tested (EU).

  COUNTRY SPECIFIC INFORMATION

  Germany

  WGK: 3 Self-Classification

• 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.