Atorvastatin calcium

CAS Number
134523-03-8
EC Number
627-026-0
Chemical Formula
C33H35FN2O5.1/2Ca
Molecular Weight
1155.3 g/mol

Description

Atorvastatin calcium (CAS 134523-03-8), also known by the trade names Tahor and CI-981, is a pharmaceutical active ingredient used in the manufacture of cholesterol-lowering medications. It functions as an HMG-CoA reductase inhibitor and is the active salt form selected for its stability and bioavailability profile in solid dosage manufacturing for global pharmaceutical supply chains.

The primary application is in the production of oral solid dosage forms, such as tablets and film-coated tablets, for lipid management therapies where the calcium salt form supports consistent dissolution. Generic pharmaceutical manufacturers source it as the API for finished drug product registration across regulated markets including FDA, EMA, and WHO-prequalified supply chains for international distribution.

Contract development and manufacturing organizations (CDMOs) use it in formulation development projects requiring ICH-compliant starting materials to ensure high-quality therapeutic outcomes for patients. It is also sourced by quality control laboratories and reference standard suppliers for analytical method validation and comparative testing according to strict regulatory requirements and internal protocols.

Atorvastatin calcium is supplied as a white to off-white crystalline powder. It is available in anhydrous and trihydrate forms, with the trihydrate being the most commercially prevalent in manufacturing. Standard grades include USP, BP, and Ph. Eur., with documentation packages typically including CoA, DMF references, and impurity profiles aligned to pharmacopoeial specifications.

Other Names (Synonyms)

atorvastatin calcium anhydrous|Tahor|CI-981|Liprimar|C0GEJ5QCSO|YM 548

Key Technical Features

  • High Purity Grade standard
  • Consistent Batch Quality
  • Full Regulatory & REACH Support
  • Global Logistics Network enabled

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Physical Properties

Melting Point 249.45 °C
Appearance White Crystalline Powder
Color White to Off-White
Form white powder

Documentation

Safety & Handling Learn More

Warning
GHS07· Irritant GHS08· Health Hazard GHS09· Environmental Hazard

Hazard Statements

H315 Causes skin irritation
H319 Causes serious eye irritation
H335 May cause respiratory irritation
H351 Suspected of causing cancer

Precautionary Statements

P203 Obtain, consult and follow expert instructions for use.
P260 Do not breathe dust/fume/gas/mist/vapours/spray.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P263 Avoid contact during pregnancy and while nursing.

Trade & Regulatory

Storage Class 11 - Combustible Solids
WGK (Germany) 3
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