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for Active Substance to be imported into European Union (EU).Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride SDS of Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
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Synonyms: Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride
CAS Number: 486459-71-6 or 862156-92-1 for monohydrate, Molecular Weight: 443.77 or 461.79 for monohydrate, Chemical Formula: C16H16ClF6N5O, EINECS EC Number: 813-550-9 or 815-123-2 for monohydrate, FEMA: ----,Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 18-Feb-241. Product Identification
Product Name & Other Names: Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride.
CAS No.: 486459-71-6 or 862156-92-1 for monohydrate
EINECS EC Number: 813-550-9 or 815-123-2 for monohydrate
Molecular Weight: 443.77 or 461.79 for monohydrate
Chemical Formula: C16H16ClF6N5O
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008Acute toxicity, oral Category 4, H302
Skin corrosion/irritation Category 2, H315
Serious eye damage/eye irritation Category 2A, H319
Specific target organ toxicity, single exposure; Respiratory tract irritation Category 3, H335Labeling according to Regulation (EC) No 1272/2008
GHS Label Elements
IrritantSignal Words: Warning
Hazard statements:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.Precautionary statements:
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash skin thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
P273: Avoid release to the environment.
P330: Rinse mouth.
P362: Take off contaminated clothing and wash before reuse.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P332+313: If skin irritation occurs: Get medical advice/attention.
P302+ P352 - IF ON SKIN: Wash with plenty of soap and water.
P305+ P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P332+313: If skin irritation occurs: Get medical advice/attention.
P337+P313 If eye irritation persists: Get medical advice/ attention.
P501: Dispose of contents/container to authorized agents only.Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xi Irritant.
Xn Harmful.
Risk Phrases:
R22: Harmful if swallowed.
R36/37/38: Irritating to eyes, respiratory system & skin.3. Composition/Information on Ingredients
Product Name & Other Names:Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride.
CAS No.: 486459-71-6 or 862156-92-1 for monohydrate
EINECS EC Number: 813-550-9 or 815-123-2 for monohydrate.4. First Aid Measures
Inhalation:Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Keep person warm and quiet; get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact: Immediately flush skin with plenty of soap and water for at least 15 minutes. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention if irritation develops.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention.5. Fire Fighting Measures
Fire: May become a fire hazard at high temperatures.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Avoid solid water jet as it may scatter the fire.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Fluorine compounds, Hydrogen chloride gas, Fumes.
Special Information In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes.6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container.7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Avoid dust formation and control ignition sources. Containers may be hazardous when empty. Storage: Refrigerate. OK to freeze. Short term shipping may be at room temperature.8. Exposure Controls/Personal Protection
Airborne Exposure Limits: Contains no substances with occupational exposure limit values.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.9. Physical and Chemical Properties
Appearance: White powder,
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Boiling Point: Not available.
Melting Point: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Not available.
Viscosity: Not available.
Molecular Weight: 443.77 or 461.79 for monohydrate
Chemical Formula: C16H16ClF6N5O10. Stability and Reactivity
Stability: ;Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Nitrogen oxides, Fluorine compounds, and carbon oxides along with chlorine compounds and fumes.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flame, ignition sources, dusting, and incompatibles.11. Toxicological Information
LD50 Oral - Rat - Not available.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.12. Ecological Information
Persistence and Degradability: No information available.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. Dispose of container and unused Methylene Blue in accordance with legal requirements.
14. Transport Information
DOT USA, TDG and ADR/RID Europe: Not regulated.
IATA and IMDG/IMO: Not regulated.15. Regulatory Information
USA:
SARA 311/312 Hazardous Categorization: Acute Health Hazard as per section 2.
California Proposition 65: This product does not contain any Proposition 65 chemicals.16. Other Information
European Labeling in Accordance with EC Directives:
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
Hazard Symbols:
Xi Irritant.
Xn Harmful.
Risk Phrases:
R22: Harmful if swallowed.
R36/37/38: Irritating to eyes, respiratory system & skin.Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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Manufacturer Supplier Exporter
ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIAe-mail: info@anmol.org
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Last updated 3-mar-24Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only. No other use is permitted.
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