Glipizide
Glipizide is an oral diabetes medicine that helps control blood sugar levels by helping your pancreas produce insulin.
Glipizide is used together with diet and exercise to treat type 2 diabetes. Glipizide may also be used for purposes not listed in this medication guide.
Certificate of Analysis
- Description
Almost white, crystalline powder.
Result
Complies
- Solubility
Practically insoluble in water, practically insoluble in Ethanol 95 %.
Result
Complies
- Identification by IR
To comply
Result
Passes
- Identification by UV
To comply
Result
Passes
- Identification by TLC
To Comply positively
Result
Passes
- Related substance By HPLC
Result - Impurity A
NMT 0.30 %
Result
Passes
- Impurity D
NMT 0.10%
Result
Passes
- Impurity E
NMT 0.1%
Result
Passes
- Unknown Impurity
NMT 0.10%
Result
Passes
- Overall Impurities
NMT 0.50%
Result
Passes
- L.O.D.
NMT 0.50 % w/w
Result
Passes
- Sulphated Ash
NMT 0.20 % w/white
Result
Passes
- Assay
98.0 % TO 102.0 % w/w
Result
Passes
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Material Safety Data Sheet
-
Section 1 – Chemical Product
Product Identifier
Glipizide
MSDS Prepared By
R&D Department
-
Section 2 – Composition / Information Of Ingredients
Product Name
Glipizide
Molecular Formula
C21H27N5O4S
Molecular Weight
445.2801
CAS Number
29094-61-9
-
Section 3 – HAZARDOUS IDENTIFICATION
Potential Health effects
Eye
May cause eye irritation.
Skin
May cause skin irritation. May be harmful if absorbed through the skin. Absorption through the skin may cause “salicylism, “characterized by deep and rapid breathing, nausea, vomiting, tinnitus, gastrointestinal irritation with possible ulcers and possible strokes.
Ingestion
May cause irritation of the digestive tract. May be harmful if swallowed. May cause “salicylism “with effects similar to skin.
Inhalation
May cause respiratory tract irritation. May be harmful if inhaled. May cause “salicylism” with effects similar skin absorption.
Potential Chronic Health Effects
CARCINOGENIC EFFECTS
N/A
MUTAGENIC EFFECTS
N/A
TERATOGENIC EFFECTS
N/A
DEVELOPMENTAL TOXICITY
N/A
May cause “salicylism” with effects similar to skin absorption.
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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
General Information
As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear.
Extinguishing Media
In case of fire use water spray, dry chemical, carbon dioxide, or chemical foam.
-
Section 6 – ACCIDENT RELEASE MEASURES
Small Spill
Vacuum or sweep up material and place into a suitable disposal container.
-
Section 7 – HANDLING AND STORAGE
Handling
Avoid breathing dust, vapor, mist, or gas. Avoid contact with skin and eyes.
Storage
Keep Tightly Closed. Store in a dry area. Store at around 30°C.
-
Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering Controls
Use adequate ventilation to keep airborne concentrations low.
Personal Protective Equipment
Eye
N/A
Skin
Wear appropriate protective gloves to prevent skin exposure.
Clothing
Wear appropriate protective clothing to prevent skin exposure.
Respirators
Follow the OSHA respirator regulations found in 29CFR 1910.134 or European Standard EN 149. Always use a NIOSH or European Standard EN 149 approved respirator when necessary.
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Section 9 – PHYSICAL AND CHEMICAL PROPERITIES
Physical State
Powder
Appearance
White
Odor
Odorless
pH
N/A
Vapor Pressure
N/A
Vapor Density
N/A
Evaporation Rate
N/A
Viscosity
N/A
Boiling Point
N/A
Freezing/Melting Point
N/A
Auto ignition Temperature
N/A
Flash Point
N/A
NFPA Rating
Not Published.
Explosion Limits, Lower
N/A
Upper
-
Section 10 – STABILITY AND REACTIVITY
Chemical Stability
N/A
Conditions to Avoid
Incompatible materials.
Incompatibilities with Other Materials
Strong oxidizing agents
Hazardous decomposition products
Nitrogen oxides, carbon monoxide, carbon dioxide, hydrogen fluoride.
Hazardous Polymerization
Will not occur.
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Section 11 – TOXICOLOGICAL INFORMATION
RTECS#
CAS# <>-<>-<>: YS7640000
LD50/LC50
N/A
Carcinogenicity
Not listed by ACGIH, IARC, NIOSH, NTP, or OSHA.
Epidemiology
N/A
Teratogenicity
N/A
Reproductive Effects
N/A
Neurotoxicity
N/A
Mutagenicity
N/A
Other Studies
The toxicological properties have not been fully investigated.
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Section 12 – ECOLOGICAL INFORMATION
Data Not available.
N/A
-
Section 13 – DISPOSAL CONSIDERATION
Waste Disposal
Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste.US EPA guidelines for the classification determination are listed in 40 CFR Part Additionally, waste generators must consult state and local hazardous waste regulators ensure complete and accurate classification.
RCRA P-Series
None listed
RCRA U-Series
None listed
-
Section 14 – TRANSPORT INFORMATION
US DOT
N/A
Canadian TDG
N/A
-
Section 15 – REGULATORY INFORMATION
US FEDERAL
TSCA CAS# <>-<>-<> is not listed on the TSCA inventory. It is for research and development use only.
Health & Safety Reporting List
None of the chemicals are on the Health & Safety Reporting List.
Chemical Test Rules
None of the chemicals in this product are under a Chemical Test Rule.
Section 12b
None of the chemicals are listed under TSCA Section 12b. TSCA Significant New Use Rule None of the chemicals in this material have a SNUR under TSCA. SARA Section 302 (RQ): None of the chemicals in this material have an RQ.
Section 302 (TPQ)
None of the chemicals in this product have a TPQ.
Section 313
No chemicals are reportable under Section 313.
Clean Air Act
This material does not contain any hazardous air pollutants. This material does not contain any Class 1 Ozone depletes. This material does not contain any Class 2 Ozone depletes.
Clean Water Act
None of the chemicals in this product are listed as Hazardous. Substances under the CWA. None of the chemicals in this product are listed as Priority. Pollutants under the CWA. None of the chemicals in this product are listed as Toxic Pollutants under the CWA.
OSHA
None of the chemicals in this product are considered highly hazardous by OSHA.
State
Glipizide (USP) is not present on state lists from CA, PA, MN, MA, FL, or NJ. California No
Significant Risk Level
None of the chemicals in this product are listed. European/International Regulations European Labeling in Accordance with EC Directives.
Hazard Symbols
N/A
Risk Phrases
Safety Phrases
S 24/25 Avoid contact with skin and eyes. WGK (Water Danger/Protection) CAS# <>-<>-<>: No Information available. United Kingdom Occupational Exposure Limits.
Canada
None of the chemicals in this product are listed on the DSL/NDSL list.
WHMIS
N/A
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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.