Aripiprazole

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Cat Number

API129722129

CAS Number

129722-12-9

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Product Detail Description Scientific Support Customer Q&A

CAS Number

129722-12-9

EINECS

603-355-5

Storage

Store at room temperature

Synonyms

Abilitat; OPC-14597; Abilify Discmelt; aripiprazol; Discmelt; Opc 14597; Aripiprex; Abilify MyCite; OPC 31; 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone

Molecular Formula

C23H27Cl2N3O2

Molecular Weight

448.4

Smiles

C1CC(=O)NC2=C1C=CC(=C2)OCCCCN3CCN(CC3)C4=C(C(=CC=C4)Cl)Cl

Appearance

White to light yellow powder to crystal

Melting Point

139℃

Boiling Point

646.2℃ at 760 mmHg

Relative Density

1.263±0.06

General Description

Aripiprazole is a third-generation or atypical antipsychotic that is FDA-approved for the management of several psychiatric disorders. It is a small molecule drug that exhibits high affinity for dopamine D2 and D3, and serotonin 5-HT1A and 5-HT2A receptors.

Mechanism of Action

The mechanism of aripiprazole is unique among antipsychotics and is mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors, and antagonist activity at 5-HT2A receptors. This functional selectivity allows it to stabilize dopamine activity, reducing it in areas of hyperactivity (e.g., mesolimbic pathway) while increasing it in areas of hypoactivity (e.g., mesocortical pathway).

Application

Aripiprazole is indicated for the symptomatic management of psychosis in schizophrenia, as monotherapy or adjunctive therapy for acute manic episodes associated with bipolar I disorder, and as an adjunctive treatment for major depressive disorder. It is also FDA-approved for the treatment of irritability associated with autistic disorder and for Tourette syndrome.

This Cochrane review identified three small trials (885 participants, 707 for quantitative analysis) comparing intramuscular aripiprazole with placebo, haloperidol, or olanzapine for acute psychosis‑induced agitation. Aripiprazole reduced the need for additional injections compared with placebo (RR 0.69) and improved agitation at two hours. Against haloperidol, aripiprazole required more injections. Compared with olanzapine, aripiprazole was less effective at reducing agitation but caused less somnolence. Evidence quality was very low to low; economic outcomes were not reported. Larger, more pragmatic trials are needed to determine aripiprazole’s role in rapid tranquillisation.

Fig. 1 Study flow diagram (2017 search). (Ostinelli EG, et al., 2018)

References

Ostinelli EG, et al. Aripiprazole (intramuscular) for psychosis-induced aggression or agitation (rapid tranquillisation). Cochrane Database Syst Rev. 2018;1(1):CD008074.

Does Aripiprazole require protection from light during long-term storage?

Yes, it is photosensitive. UV light can cause photodegradation and discoloration. Store in light-resistant, tightly sealed containers, preferably original packaging.

What is the recommended storage temperature for Aripiprazole?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, which can cause polymorphic transformation from the stable Form I to less stable forms.

Is Aripiprazole sensitive to moisture, and how does this affect stability?

It is slightly hygroscopic. Under high humidity, it may absorb moisture, leading to caking and potential hydrolysis of the carboxamide group. Store with desiccant.

How is the impurity Aripiprazole N-oxide monitored during stability?

This oxidative degradation product is specifically quantified using a stability-indicating HPLC method, ensuring it remains below pharmacopoeial limits.