CAS Number 134523-03-8 Anhydrous and 344423-98-9 Trihydrate, Atorvastatin Calcium EP BP Ph Eur USP Grade Manufacturers Exporters
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CAS Number 134523-03-8 for Anhydrous and 344423-98-9 for Trihydrate, Atorvastatin Calcium EP BP Ph Eur USP Manufacturer Exporter
For Properties Specifications of Atorvastatin Calcium Click Properties, Specifications of Atorvastatin Calcium Manufacturer.
For Uses of Atorvastatin Calcium Click Uses of Atorvastatin Calcium Manufacturer.
For For SDS MSDS Sheet of Atorvastatin Calcium Click SDS Safety Data Sheet MSDS Sheet of Atorvastatin Calcium Manufacturer.
The Properties and Specifications of Atorvastatin Calcium:
Atorvastatin Calcium USP Grade Specifications:
C66H68CaF2N4O10 --- 1155.36
1H -Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, calcium salt (2:1), [R-(R*,R*)]-;
Calcium (&beta R,δ R)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2);
[(3R ,5R )-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H -pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt]
Anhydrous CAS 134523-03-8
C66H68CaF2N4O10-3H2O --- 1209.41
Trihydrate CAS 344423-98-9
C66H68CaF2N4O10- C3H8O2
Propylene glycol solvate 1231.46
UNII: C0GEJ5QCSO
DEFINITION
Atorvastatin Calcium contains NLT 98.0% and NMT 102.0% of atorvastatin calcium (C66H68CaF2N4O10), calculated on the anhydrous and solvent-free basis. If labeled as a propylene glycol solvate, it contains NLT 98.0% and NMT 102.0% of atorvastatin calcium (C66H68CaF2N4O10), calculated on the anhydrous, propylene glycol-free, and solvent-free basis. It may contain a suitable antioxidant.
IDENTIFICATION
A. Infrared Absorption.
B. Calcium.
Content of Propylene Glycol (if labeled as a propylene glycol solvate): To pass the test. Acceptance criteria: 5.4%–7.3%
Organic Impurities: To pass the test.
Enantiomeric Purity: To pass the test.
Water Determination: 3.5%–5.5% for the trihydrate form. If labeled as amorphous or as semicrystalline, NMT 6.0%. If labeled as a propylene glycol solvate, NMT 1.0%.
Atorvastatin Calcium Trihydrate BP Ph Eur Grade Specifications:
C66H68CaF2N4O10-3H2O --- 1209 --- 344423-98-9
Action and use: HMG Co-A reductase inhibitor; lipid-regulating drug.
DEFINITION
Calcium (3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate trihydrate.
Content: 97.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: White or almost white powder.
Solubility: Very slightly soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride.
It shows polymorphism.
IDENTIFICATION
A. Infrared absorption spectrophotometry.
If the spectra obtained in the solid-state show differences, dissolve the substance to be examined and the reference substance separately in methanol, evaporate to dryness and record new spectra using the residues.
B. Enantiomeric purity
C. Water.
D. Ignite. The residue gives reaction (b) of calcium. Filtration may be necessary in case the residue does not completely dissolve.
TESTS
Enantiomeric purity: To pass the test by liquid chromatography.
Related substances: To pass the test by liquid chromatography.
Sodium: Maximum 0.4 per cent (anhydrous substance).
Atomic absorption spectrometry: To pass the test.
Water: 3.5 per cent to 5.5 per cent, determined on 0.130 g.
We also supply Atorvastatin Calcium EP Grade.
The Uses of Atorvastatin Calcium:
Atorvastatin Calcium is used to lower the amount of cholesterol in the blood and to prevent stroke, heart attack, and angina (chest pain). It is also being studied in the prevention and treatment of some types of cancer and other conditions. Atorvastatin is commonly used to lower bad cholesterol levels and fats in the blood. It also increases good cholesterol levels.The MSDS-SDS Hazard Statement of Atorvastatin Calcium:
Atorvastatin Calcium Anhydrous Trihydrate SDS, Safety Data Sheet, MSDS, Material Safety Data Sheet 09-Nov-24
SECTION 1. PRODUCT IDENTIFICATION
Product Name & Other Names: Atorvastatin Calcium Anhydrous Trihydrate.
CAS Number: 134523-03-8 for Anhydrous and 344423-98-9 for Trihydrate
EINECS EC Number: 627-026-0 or 658-046-8
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Supplier: As per the letterhead.
SECTION 2. HAZARDS IDENTIFICATION
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Eye irritation, (Category 2) H319
Specific target organ toxicity, repeated exposure (Category 2), H373
Long-term (chronic) aquatic hazard (Category 2), H411
Labeling according to GHS USA & Regulation (EC) No 1272/2008
GHS Label Elements  Irritant |
GHS Label Elements |
GHS Label Elements |
Signal Words: Danger
Hazard statements:
H319: Causes serious eye irritation.
H373: May cause damage to organs through prolonged or repeated exposure.
H411: Toxic to aquatic life with long lasting effects.
Precautionary statements:
P261: Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P262: Do not get in eyes, on skin, or on clothing.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P330: Rinse mouth.
P302+P352: IF ON SKIN: Wash with soap and water.
P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/ attention.
SECTION 3. COMPOSITION / INFORMATION ON INGREDIENTS
Product Name & Other Names: Atorvastatin Calcium Anhydrous Trihydrate.
CAS Number: 134523-03-8 for Anhydrous and 344423-98-9 for Trihydrate
EINECS EC Number: 627-026-0 or 658-046-8
SECTION 4. FIRST AID MEASURES
Always seek medical attention after first aid measures are provided.
Eye Contact: Do not allow victim to rub eye (s). Let the eye (s) water naturally for a few minutes. If particle/dust does not dislodge, flush with lukewarm, gently flowing water for 5 minutes or until particle/dust is removed, while holding eyelid (s) open. If irritation persists, obtain medical attention.
Skin Contact: Remove contaminated clothing, shoes, and leather goods (e.g., watchbands, belts). Quickly and gently blot or brush away excess chemicals. Wash gently and thoroughly with lukewarm gently flowing water and non-abrasive soap for 5 minutes. Obtain medical advice.
Inhalation: If symptoms are experienced, remove source of contamination or move victim to fresh air. Obtain medical advice.
Ingestion: Never give anything by mouth if victim is rapidly losing consciousness or is unconscious or convulsing. Have the victim rinse their mouth thoroughly with water. DO NOT INDUCE VOMITING. Have the victim drink 2 – 8 oz. (60 – 240 ml) of water.
SECTION 5. FIRE FIGHTING MEASURES
Fire and Explosion Hazards: Not a fire hazard. It may burn at high temperature
Extinguishing Media: Use means of extinction appropriate for the surrounding fire conditions such as water spray, carbon dioxide, dry chemical, or foam. Avoid solid water jet.
Fire Fighting: Apart from oxides of carbon, oxides of nitrogen, fluorine compounds, calcium oxide, toxic fumes may result from combustion. As with any fire, fire-fighters should be fully trained and wear full protective clothing including an approved, self-contained breathing apparatus which supplies a positive air pressure within a full-face piece mask. Do not use solid water jet directly on material. Use water spray to cool unopened containers. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used.
SECTION 6. ACCIDENTAL RELEASE MEASURES
Procedures for Cleanup: Stop release, if possible, to do so safely. Contain spill, isolate hazard area, and deny entry. Sweep up or vacuum. Place contaminated material in suitable, labeled containers for final disposal.
Personal Precautions: Gloves and coveralls or other protective clothing are recommended for persons responding to an accidental release.
Environmental Precautions: Contamination of soil and water should be prevented. Keep spillage from entering soil, streams, or sewers.
SECTION 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.).
Conditions for safe storage, including any incompatibilities: Keep away from sources of ignition - No smoking. Take measures to prevent the build-up of electrostatic charge. 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. generating dust and the release of dust into the workplace. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Do not store with incompatible materials like oxidizing agents. Storage: Refrigerate. OK to freeze.
SECTION 8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
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.
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: White or almost white powder. Hygroscopic.
Odor: No data found.
Odor threshold: No data found.
pH in 1 % solution: No data found.
Relative density: No data found.
Melting point/freezing point: 176C- 178C literature.
Initial boiling point and boiling range: 722C literature.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility(ies): Very slightly soluble in water, slightly soluble in ethanol.
Viscosity: No data found.
SECTION 10. STABILITY AND REACTIVITY
Stability and Reactivity: Stable and not considered reactive under recommended temperatures and pressures. Hazardous polymerization or runaway reactions will not occur.
Incompatibilities: Oxidizing agents. Avoid excessive heat.
Hazardous Decomposition Products: High temperature operations will generate carbon oxides, nitrogen oxides fluorine compounds, calcium oxide and fumes.
SECTION 11. TOXICOLOGICAL INFORMATION
Acute Toxicity Oral LD50 Rat: > 5000 mg/kg Rat.
Dermal LD50 Rabbit: > 2.000 mg/kg
May cause damage to organs through prolonged or repeated exposure.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Teratogenic Effects: No data found.
Mutagenic Effects: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.
SECTION 12. ECOLOGICAL INFORMATION
Toxicity to fish: LC50 - Oncorhynchus mykiss (rainbow trout) - > 92 mg/l - 96 h.
Persistence and Degradability: Not readily biodegradable.
Mobility: No data found.
Bioaccumulation/ Accumulation: No data found.
Results of PBT and vPvB assessment: No data available for assessment.
SECTION 13. DISPOSAL CONSIDERATIONS
Do not wash the material down drain. Put uncontaminated material back into the process if possible. Place contaminated material in suitable, labeled containers for disposal. Dispose of waste material as per pollution control norms.
SECTION 14. TRANSPORT INFORMATION
DOT USA, TDG Canada & ADR/RID Europe: Not controlled.
IATA/ICAO: Not controlled.
IMDG/IMO: Not controlled.
SECTION 15. REGULATORY INFORMATION
USA Regulations:
SARA 311/312 Hazards: See section 2.
SECTION 16 - ADDITIONAL INFORMATION
DISCLAIMER: The information and recommendations set forth herein are presented in good faith and believed correct as of the date hereof. It is compiled from various sources, and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules, or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a professionally trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.
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Atorvastatin Calcium Structure
CAS Number 134523-03-8 for Anhydrous and 344423-98-9 for Trihydrate, Atorvastatin Calcium Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 16-nov-24
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