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Aripiprazole API

Price 5000.0 INR/ Kilograms

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MOQ : 1000 Kilograms

Aripiprazole API Specification

HS Code
29339900

Solubility
Practically insoluble in water; soluble in methanol, slightly soluble in ethanol

Particle Size
D90 < 10 microns

Smell
Odorless

Heavy Metal (%)
NMT 0.001%

Structural Formula
Available on request

Melting Point
138-140C

Storage
Store below 25C, protected from light and moisture

Taste
Bitter

Shelf Life
5 years from date of manufacture

Color
White to off-white

Molecular Weight
448.39 g/mol

Ph Level
6.0-8.0 (in aqueous suspension)

Molecular Formula
C23H27Cl2N3O2

Poisonous
No (when used as directed in pharmaceutical preparations)

Boiling point
Not applicable (decomposes)

Loss on Drying
NMT 0.5%

Medicine Name
Aripiprazole

Chemical Name
7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril

CAS No
129722-12-9

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as an antipsychotic agent in the treatment of schizophrenia and bipolar disorder

Purity(%)
>=99%

Appearance
White to off-white powder

Physical Form
Solid

Specific Optical Rotation
Not applicable (not chiral)

Residual Solvents
Meets ICH guideline limits

Identification
Positive (as per pharmacopeial methods)

Assay (by HPLC)
>=99%

Polymorphic Form
Form I (unless otherwise specified)

Packaging
HDPE drums with double polyethylene liners

Endotoxin Level
Less than 0.25 EU/mg

Microbial Limit
TAMC: NMT 100 cfu/g, TYMC: NMT 10 cfu/g, E. coli: Absent

Impurity Profile
Complies with pharmacopeial standards (EP/USP/JP)

Aripiprazole API Trade Information

Minimum Order Quantity
1000 Kilograms

Supply Ability
1000 Kilograms Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Aripiprazole API

Chemical Formula	C13H16ClNO2
Form	Powder
Usage/Application	Pharmaceutical Industry
Color	White
CAS No	120004-79-7
Packaging Type	carboy

7(4CHLOROBUTOXY)3,4DIHYDROQUINOLIN2-ONE

High Purity & Compliance

Aripiprazole API is rigorously tested to ensure 99% purity as determined by HPLC and adheres to international pharmacopeial standards (EP/USP/JP) for identity, assay, impurity profile, and microbiological limits. This ensures pharmaceutical formulations made with our API are consistent, safe, and effective.

Safe Storage & Handling

This API is stored below 25C, shielded from light and moisture to prevent degradation. The product is supplied in HDPE drums lined with double polyethylene liners to maintain product quality and avoid contamination during transportation and storage.

Application & Benefits

Aripiprazole API is a trusted antipsychotic agent utilized in the treatment of schizophrenia and bipolar disorder. Its high purity and safety profile contribute to superior efficacy and patient tolerability in finished dosage forms. Supplied as a free-flowing white to off-white powder, it ensures ease of formulation in pharmaceutical manufacturing.

FAQ's of Aripiprazole API:

Q: How is the purity and quality of Aripiprazole API ensured?

A: Aripiprazole API is tested for assay (99% by HPLC), impurity profile, residual solvents, and microbial parameters as per EP/USP/JP pharmacopeial standards. Each batch complies with stringent guidelines for identity, purity, heavy metals (NMT 0.001%), and endotoxin levels, ensuring the highest quality for pharmaceutical use.

Q: What is the recommended storage condition for Aripiprazole API?

A: The API should be stored below 25C, protected from light and moisture for optimal stability. The API is supplied in HDPE drums with double polyethylene liners to safeguard against contamination and environmental exposure.

Q: When should Aripiprazole API be used in pharmaceutical manufacturing?

A: This API is typically used during the production of antipsychotic medications intended for schizophrenia and bipolar disorder. Pharmaceutical manufacturers should use it in accordance with regulatory-approved formulations and validated processes.

Q: Where can Aripiprazole API be sourced from?

A: Aripiprazole API is available from reputable manufacturers, exporters, and suppliers based in India who adhere to international quality standards. It is widely distributed for use in pharmaceutical production across global markets.

Q: What is the process for verifying the authenticity of the supplied API?

A: Authenticity and quality are verified using pharmacopeial identification tests, positive assay results, impurity analysis, microbial limits, and batch documentation. Structural formula details and COA (Certificate of Analysis) are provided on request.

Q: How is Aripiprazole API typically used, and what are its benefits?

A: This API is formulated into oral or injectable medicines by pharmaceutical companies. Its benefits include a high safety margin, effective symptom management in psychiatric disorders, and compliance with regulatory standards, resulting in quality assured therapy for patients.

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