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
    Methanol

    NMT 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 A

    NMT 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%

Note: Note: – We are leading channel partner of much API manufacturer, supplier & exporters and Pharmaceutical raw material in Colombo, Chili, Ecuador and Globally.

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.

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