Atorvastatin

CAS Number
134523-00-5
EC Number
806-698-0
Chemical Formula
C33H35FN2O5
Molecular Weight
558.6 g/mol

Description

Atorvastatin (CAS 134523-00-5), also known by the brand name Lipitor, is a synthetic HMG-CoA reductase inhibitor used as an active pharmaceutical ingredient in prescription cholesterol-lowering medications. It is one of the most commercially significant statin APIs in global pharmaceutical manufacturing and procurement. Atorvastatin API is the core active ingredient in finished oral solid dosage forms.

Primarily film-coated tablets are manufactured for cardiovascular disease management using this material. Generic drug manufacturers source it to produce bioequivalent formulations requiring strict pharmacokinetic matching. These formulations must match reference listed drugs. Contract development and manufacturing organizations (CDMOs) use it in formulation development projects targeting lipid-lowering therapeutic categories.

It also appears in combination tablet formulations, paired with antihypertensives such as amlodipine. This requires compatibility evaluation during development to ensure stability and efficacy. Atorvastatin is supplied as a white to off-white crystalline powder in pharmaceutical-grade form. Standard specifications include USP, BP, and Ph. Eur. grades for global compliance.

Purity is typically at 98% or above as required for API use. Packaging is available in quantities ranging from research-scale to commercial bulk for various manufacturing needs. Documentation including CoA, DMF references, and impurity profiles are available on request. This ensures full transparency and regulatory support for pharmaceutical procurement teams.

Other Names (Synonyms)

LCF872|Cardyl|A0JWA85V8F

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 167.73 °C
Boiling Point 722.2±60.0 °C(Predicted)
Density 1.23±0.1 g/cm3(Predicted)
Color White to light yellow
Form Solid

Documentation

Safety & Handling Learn More

Warning
GHS07· Irritant GHS08· Health Hazard

Hazard Statements

H315 Causes skin irritation
H319 Causes serious eye irritation
H335 May cause respiratory irritation
H361 Suspected of damaging fertility or the unborn child
H362 May cause harm to breast-fed children

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

HS Code 35040000
Storage Class 11 - Combustible Solids
WGK (Germany) 3
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