Aripiprazole IP BP EP Ph Eur USP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Aripiprazole, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal etc.

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Aripiprazole CAS Number 129722-12-9, EINECS EC Number: 603-355-5, Molecular Formula: C23H27Cl2N3O2, Molecular Weight: 448.39, HS Code 29337908 or 29337900

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SDS MSDS Sheet of Aripiprazole Manufacturers

Aripiprazole
IP BP EP Ph Eur USP Grade Suppliers
Aripiprazole

Aripiprazole is an atypical antipsychotic drug.

General Properties and Specifications of Aripiprazole:
Appearance: White to off-white, crystalline powder.
Assay: Between 98% and 102%
Identifications: By IR and by HPLC.
Loss on drying: 0.5% maximum.
Residue on ignition: 0.1% maximum.
Related inpurities:
Aripiprazole related compound G: 0.1% maximum.
Aripiprazole related compound F: 0.1% maximum.
Aripiprazole 4,4’ dimer: 0.1% maximum.
Any other individual impurity: 0.1% maximum.
Total impurities: 0.5% maximum.
Residual solvents:
Methanol: 1000 ppm maximum.
Isopropyl alcohol: 1000 ppm maximum.
Acetonitrile: 300 ppm maximum.
N-Hexane: 200 ppm maximum.
Tetrahydrofurane: 600 ppm maximum.
Triethylamine: 320 ppm maximum.
Relative Density: about 1.3
Melting Point: 137C to 140C literature.
Boiling Point: 646C.
Solubility: Freely soluble in dichloromethane. Sparingly soluble in toluene. Insoluble in methanol and water.
Storage: Preferably 2C to 8C. OK to freeze. Protected from light.


Aripiprazole USP Grade Specifications:
C23H27Cl2N3O2 448.39
2(1H)-Quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-;
7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril CAS 129722-12-9].
UNII: 82VFR53I78

DEFINITION
Aripiprazole contains NLT 98.0% and NMT 102.0% of aripiprazole (C23H27Cl2N3O2), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test.
Aripiprazole related compound G: 0.1% maximum.
Aripiprazole related compound F: 0.1% maximum.
Aripiprazole 4,4’ dimer: 0.1% maximum.
Any other individual impurity: 0.1% maximum.
Total impurities: 0.5% maximum.
Loss on Drying: Dry at 105C for 3 h. Aceptance criteria: NMT 0.5%
Packaging and Storage: Preserve in tight containers. Store at controlled room temperature.


Aripiprazole BP Ph Eur Grade:
C23H27Cl2N3O2 --- 448.4 CAS 129722-12-9
Action and use: Dopamine D2 receptor antagonist; neuroleptic.

DEFINITION
7-[4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydroquinolin-2(1H)-one.
Content: 98.0 per cent to 102.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white crystals or crystalline powder.
Solubility: Practically insoluble in water, soluble in methylene chloride, very slightly soluble in ethanol (96 per cent).
It shows polymorphism.

IDENTIFICATION
Infrared absorption spectrophotometry

Appearance of solution: If intended for use in the manufacture of parenteral preparations, the solution is clear and not more intensely coloured than reference solution.
Related substances: To pass the test.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C for 3 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Bacterial endotoxins: Less than 5 IU/mg, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins.
Dissolve 1.0 mg of the substance to be examined in 20 mL of a 5.17 g/L solution of hydrochloric acid.
Storage: Protected from light. If the substance is sterile, store it in a sterile, airtight, tamper-proof container.

For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

We also manufacture and supply as under:

Aripiprazole

4-Amino 1,2,4-Triazole

1,2,3-Benzotriazole

Ensulizole

Imidazole

Tolytriazole.

Manufacturers:

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)

Manufacturers india
Copyright and Usual Disclaimer is Applicable.
Last 25 January, 2024

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Aripiprazole SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
25-Jan-24

1. Product Identification

Product Name & Other Names: Aripiprazole.
CAS No.: 129722-12-9
EINECS EC Number: 603-355-5
Molecular Weight: 448.39
Chemical Formula: C23H27Cl2N3O2
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 1272/2008

Acute toxicity, oral Category 4, H302

Labeling according to Regulation (EC) No 1272/2008

GHS Label Elements
Irritant
Irritant

Signal Words: Warning

Hazard statements:
H302: Harmful if swallowed.

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.
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:
Xn Harmful.
Risk Phrases:
R22: Harmful if swallowed.

3. Composition/Information on Ingredients

Product Name & Other Names: Aripiprazole.
CAS No.: 129722-12-9
EINECS EC Number: 603-355-5

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.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas, Chlorine compounds.
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. 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: Preferably 2C to 8C. OK to freeze. Protected from light.

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.
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 to off-white, crystalline powder.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: about 1.3
Boiling Point: 646C.
Melting Point: 137C to 140C literature.
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: Freely soluble in dichloromethane. Sparingly soluble in toluene. Insoluble in water.
Viscosity: Not available.
Molecular Weight: 448.39
Chemical Formula: C23H27Cl2N3O2

10. Stability and Reactivity

Stability: Stable under recommended conditions of use and storage.
Hazardous Decomposition Products: Nitrogen & carbon oxides along with chlorine compounds.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, light, flame, ignition sources, dusting, and incompatibles.

11. Toxicological Information

LD50 Oral - Rat - 953 mg/kg.
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

Toxicity to fish: LC50 - Fish - > 120 mg/l - 96 h.
Persistence and Degradability
: 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.

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:
H302: Harmful if swallowed.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn Harmful.
Risk Phrases:
R22: Harmful if swallowed.

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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