Indapamide
Indapamide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.
Indapamide treats fluid retention (edema) in people with congestive heart failure. indapamide is also used to treat high blood pressure (hypertension).
Indapamide may also be used for purposes not listed in this medication guide.
Certificate of Analysis
- Description
White to almost white, crystalline powder.
Result
Complies
- Identification by IR
Positive
Result
Positive
- Identification by Na
Negative
Result
Negative
- Solubility
Practically insoluble in Water, Freely soluble in Ethanol
Result
Complies
- Optical Rotation
-7° to -12° c
Result
-9.4° C
- Water
1.4 to 2.0 %
Result
1.8%
- Sulphated Ash
NMT 0.2%
Result
0.01%
- Residue Solvents
MethanolNMT 200 PPM
Result
N.D. PPM
- Methylene Chloride
NMT 45 PPM
Result
N.D. PPM
- Xylene
NMT 125 PPM
Result
N.D. PPM
- Ethanol
NMT 100 PPM
Result
N.D. PPM
- Assay
97.5 – 101.0%
Result
98.5%
- Related Sustenance By HPLC
a) Impurity ANMT 0.3%
Result
N.D. %
- b) Impurity B
NMT 0.4%
Result
N.D. %
- c) Impurity C
NMT 0.2%
Result
N.D. %
- d) Impurity E
NMT 0.10%
Result
N.D. %
- e) Impurity D
NMT 0.2%
Result
N.D. %
- f) Impurity N
NMT 0.2%
Result
N.D. %
- g) Impurity F
NMT 0.2%
Result
N.D. %
- h) Impurity G
NMT 0.7%
Result
0.12%
- i) Impurity H
NMT 0.10%
Result
0.07%
- j) Impurity I
NMT 0.2%
Result
0.06%
- k) Impurity J
NMT 0.10%
Result
N.D. %
- l) Impurity O
NMT 0.10%
Result
N.D. %
- m) Impurity K
NMT 0.2%
Result
N.D. %
- n) Impurity L
NMT 0.5%
Result
N.D. %
- o) Impurity M
NMT 1.0%
Result
0.49%
- p) Unspecified Impurities
NMT 0.10%
Result
N.D. %
- q) Total Impurities
NMT 2.0%
Result
0.74%
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Material Safety Data Sheet
-
Section 1 – Chemical Product
Product Identifier
Indapamide
MSDS Prepared By
R&D Department
-
Section 2 – Composition / Information Of Ingredients
Product Name
Indapamide
Synonym
3-(Aminosulfonyl)-4-chloro-N-(2,3-dihydro-2-methyl-1H-indol-1-yl)benzamide
Molecular Formula
C16H16CIN3O3S
Molecular Weight
365.84 g/mole
CAS Number
26807-65-8
-
Section 3 – HAZARDOUS IDENTIFICATION
Potential Actuate Health Effects
Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator).
Potential Chronic Health effects
Carcinogenic Effects
N/A
Mutagenic Effects
N/A
Teratogenic effects
N/A
Developmental toxicity
N/A Repeated or prolonged exposure is not known to aggravate medical condition.
-
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. Cover the irritated skin with an emollient. If irritation persists, seek medical attention on. 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. Do not use an eye ointment. Seek medical attention.
Inhalation
Allow the victim to rest in well ventilated area. Seek 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 (N0,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
Risks of explosion of the product in presence of static discharge
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 Spill
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 ingest. Do not breathe dust. Wear suitable protective clothing in case of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes.
Storage
Store in airtight / tightly closed container away from direct sunlight and heat source.
-
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
Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Personal Protection In case of 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
Physical State
Solid
Odor
N/A
Taste
N/A
Color
N/A
pH
N/A
Boiling Point
N/A
Melting Point
167°C
Critical Temperature
N/A
Flash Point
N/A
Specific Gravity
N/A
Vapor Pressure
N/A
Vapor Density
N/A
Volatility
N/A
Odor Threshold
N/A
Ionicity (In Water)
N/A
Dispersion Properties
N/A
Solubility
N/A
-
Section 10 – STABILITY AND REACTIVITY
Chemical Stability
The product is stable.
Instability Temperature
N/A
Conditions of Instability
N/A
Incompatibility with various Substances
N/A
Corrosivity
Non-corrosive in presence of glass.
Special Remarks on Reactivity
N/A
Special Remarks on Corrosivity
N/A
Polymerization
No
-
Section 11 – TOXICOLOGICAL INFORMATION
Information on Toxicological Effects
Acute Toxicity
LD50 Oral – Rat- >3.000 mg/kg.
Skin Corrosion/irritation
N/A
Serious Eye damage / Eye irritation
N/A
Respiratory or Skin Sensitization
N/A
Germ Cell Mutagenicity
N/A
Carcinogenicity
IARC
No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.
Reproductive Toxicity
Reproductive Toxicity
No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.
Effects on Newborn
Growth statistics (e.g., reduced weight gain).
Effects on Newborn
Physical
Developmental Toxicity
Rat – Oral
Effects on Embryo or Fetus
Fetotoxicity (except death, e.g., stunted fetus
Specific Developmental Abnormalities
Musculoskeletal system
Specific target Organ Toxicity – Single Exposure
N/A
Specific target Organ Toxicity – Repeated Exposure
N/A
Aspiration Hazard
N/A
Potential Health Effects Inhalation
May be harmful if inhaled. May cause respiratory tract irritation.
Ingestion
May be harmful if swallowed.
Skin
May be harmful if absorbed through skin. May cause skin irritation.
Eyes
May cause eye irritation.
Signs & Symptoms of Exposure
To the best of our knowledge, the chemical, physical & toxicological properties have not been thoroughly investigated.