Atorvastatin Calcium USP BP Ph Eur EP Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Atorvastatin Calcium USP BP Ph Eur EP, 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, Bangladesh, etc.

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Atorvastatin Calcium CAS Number 134523-03-8 for Anhydrous and 344423-98-9 for Trihydrate, EINECS EC Number: 627-026-0 or 658-046-8, Molecular Formula: C66H68CaF2N4O10, Molecular Weight: 1155.36, HS Code 29339900 or 29420090

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for 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.

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.

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

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Atorvastatin Calcium Anhydrous Trihydrate SDS, Safety Data Sheet, MSDS, Material Safety Data Sheet 12-Aug-24

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
Molecular Formula: C66H68CaF2N4O10
Molecular Weight: 1155.36
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Supplier: As per the letterhead.

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

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.
P264 Wash skin thoroughly after handling.
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.

Classification according to European Directive 67/548/EEC as amended:
Hazard symbols:
Xn Harmful
Xi Irritant.
N Dangerous for the environment
Risk-phrases:
R20 = Harmful by inhalation.
R36 = Irritating to eyes.
R48 = Danger of serious damage to health by prolonged exposure.
R51/53 = Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

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

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. DO NOT attempt to manually remove anything stuck to the eye.
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. If irritation persists, repeat flushing. Obtain medical advice. Completely decontaminate clothing, shoes and leather goods before reuse or else discard.
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.

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 water directly on material. Do not allow water run-off to enter sewers or watercourses. 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. Uninvolved persons should evacuate to a safe place.

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. Dispose of waste material consistent with the requirements of waste disposal authorities.
Personal Precautions: Gloves and coveralls or other protective clothing are recommended for persons responding to an accidental release. Close-fitting safety goggles may be necessary in some circumstances to prevent eye contact.
Environmental Precautions: Contamination of soil and water should be prevented. Keep spillage from entering soil, streams, or sewers.

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: 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. Short term shipping may be ambient. Protect from light.

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. 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.

Appearance: White or almost white powder. Hygroscopic.
Odor: Not available.
Odor threshold: Not available.
pH in 1 % solution: Not available.
Relative density: Not available.
Melting point/freezing point: 176C- 178C literature.
Initial boiling point and boiling range: 722C 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(ies): Very slightly soluble in water, slightly soluble in ethanol.
Viscosity: Not available.
Molecular Formula: C66H68CaF2N4O10
Molecular Weight: 1155.36

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.

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: Not available.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: Not available.

Ecotoxicity:
Toxicity to fish: LC50 - Oncorhynchus mykiss (rainbow trout) - > 92 mg/l - 96 h.
Persistence and Degradability: Not readily biodegradable.
Mobility: No data available.
Bioaccumulation/ Accumulation: No data available.
Results of PBT and vPvB assessment: No data available for assessment.

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 consistent with the requirements of waste disposal authorities.

DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IATA/ICAO: Not regulated.
IMDG/IMO: Not regulated.

USA Regulations:
SARA 311/312 Hazards: Acute Health Hazard. Chronic Health Hazard. See section 2.

European Labeling in Accordance with EC Directives:
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.

European Labeling in Accordance with EC Directives:
Hazard symbols:
Xn Harmful
Xi Irritant.
N Dangerous for the environment
Risk-phrases:
R20 = Harmful by inhalation.
R36 = Irritating to eyes.
R48 = Danger of serious damage to health by prolonged exposure.
R51/53 = Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

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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