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Atorvastatin Calcium Anhydrous Trihydrate EP BP Ph Eur USP Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Atorvastatin Calcium Anhydrous Trihydrate 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.
All technical documents and DMF support available.
Atorvastatin Calcium Anhydrous Trihydrate SDS of Manufacturers
Synonyms: Atorvastatin Calcium Anhydrous Trihydrate
CAS Number: 134523-03-8 for Anhydrous and 344423-98-9 for Trihydrate, Molecular Weight: 1155.36, Chemical Formula: C66H68CaF2N4O10, EINECS EC Number: 627-026-0 or 658-046-8, FEMA: ----,
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. Improving your cholesterol levels helps decrease your risk of heart disease, stroke, and heart attack.
General Properties and Specifications of Atorvastatin Calcium:
Appearance: White or almost white powder. Hygroscopic.
Assay: 97.0 per cent to 102.0 per cent (anhydrous substance).
Melting Point: 176C- 178C literature.
Boiling Point: 722C literature.
Solubility: Very slightly soluble in water, slightly soluble in ethanol.
Storage: Refrigerate. OK to freeze. Short term shipping may be ambient. Protect from light.
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 supply Atorvastatin Calcium as per BP Ph Eur EP Grade.
Keywords: Atorvastatin Calcium Anhydrous Trihydrate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 134523-03-8 for Anhydrous and 344423-98-9 for Trihydrate Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
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, INDIA
e-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated
19-sep-24
Exporters 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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Atorvastatin Calcium Anhydrous Trihydrate
Atorvastatin Calcium Anhydrous Trihydrate BP Ph Eur EP USP Grades Manufacturers