SoleChem

Atorvastatin

CAS
134523-00-5
EC
806-698-0
Mol. 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.

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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

Safety & Handling (Learn More)

Warning GHS07 GHS08
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.
P264 Wash … 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.
P318 IF exposed or concerned, get medical advice.
P319 Get medical advice/attention if you feel unwell.
P321 Specific treatment (see … on this label).
P405 Store locked up.
P501 Dispose of contents/container in accordance with local regulations.
P264+P265 Wash … thoroughly after handling.
P302+P352 IF ON SKIN: Wash with plenty of water.
P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P332+P317 Get emergency medical help.
P337+P317 If eye irritation persists: Get medical advice/attention. Get emergency medical help.
P362+P364 Take off contaminated clothing and wash it before reuse.
P403+P233 Store in a well-ventilated place. Keep container tightly closed.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Trade & Regulatory

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

Documentation

Other Names

LCF872|Cardyl|A0JWA85V8F

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