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Quetiapine Fumarate API

Price 3500.0 INR/ Kilograms

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MOQ : 100 Kilograms

Quetiapine Fumarate API Specification

Color
White to off-white

Melting Point
170-175C

Molecular Formula
C21H25N3O2S.C4H4O4

Molecular Weight
883.11 g/mol

Loss on Drying
Not more than 0.5%

Structural Formula
Available on request

HS Code
29333990

Particle Size
D90 < 150 microns

Ph Level
4.5-6.0 (1% w/v solution)

Heavy Metal (%)
Not more than 0.001%

Shelf Life
36 months

Smell
Odorless

Storage
Store in a cool, dry place below 30C, protected from light and moisture

Taste
Bitter

Solubility
Sparingly soluble in water, freely soluble in methanol and ethanol

Poisonous
NO

Medicine Name
Quetiapine Fumarate API

Chemical Name
Quetiapine Fumarate

CAS No
111974-72-2

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Antipsychotic medication used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder

Purity(%)
>=99%

Appearance
White Or Almost White Powder

Physical Form
Powder

Related Substances
Total impurities NMT 0.2%

Assay (by HPLC)
>=99.0%

Bulk Density
0.45 - 0.55 g/ml

Microbial Limits
Total Microbial Count NMT 1000cfu/g, Yeast & Mold NMT 100cfu/g, E.coli & Salmonella absent

Residual Solvents
Complies with ICH limits

Safety Precautions
Handle using standard laboratory practices

Packaging
HDPE Drum with double polybags, 10 kg/25 kg net

Identification
Complies with standard by IR/UV/ HPLC

Quetiapine Fumarate API Trade Information

Minimum Order Quantity
100 Kilograms

Supply Ability
100 Kilograms Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Quetiapine Fumarate API

Packaging Type	Drum
Grade Standard	Lab Grade
CAS Number	111974 69 7
Purity	99%
Molecular Weight	383.5099 g/mol

Quetiapine, sold under the brand name Seroquel among others, is an atypical antipsychotic medication used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder.

Pharmaceutical Grade Quality

This Quetiapine Fumarate API is manufactured to pharmaceutical grade standards, ensuring high purity (99%) and rigorous compliance with international quality benchmarks such as ICH guidelines for residual solvents and heavy metals. Each batch passes strict analytical tests for identity and impurities, making it suitable for regulated pharmaceutical markets.

Safe Packaging and Storage

Every batch is securely packed in HDPE drums with double polybags to preserve quality during transit and storage. Optimal storage conditions-cool, dry, and away from direct light-ensure the active substance remains within specification, maximizing shelf life and therapeutic efficacy.

Reliable Efficacy and Versatility

The API's physical and chemical attributes support its effective use in tablet or capsule formulations. As an antipsychotic, it is a key active for the management of schizophrenia, bipolar disorder, and major depressive disorder, contributing to improved mental health outcomes globally.

FAQ's of Quetiapine Fumarate API:

Q: How should Quetiapine Fumarate API be stored after opening its packaging?

A: It should be stored in a cool, dry place below 30C, protected from light and moisture in well-sealed containers. This helps maintain the product's stability and purity throughout its shelf life.

Q: What is the typical usage of Quetiapine Fumarate API in pharmaceutical formulations?

A: Quetiapine Fumarate API is primarily used in the preparation of antipsychotic medications for treating schizophrenia, bipolar disorder, and major depressive disorder. It serves as the active ingredient in various dosage forms like tablets and capsules.

Q: What safety precautions should be followed when handling Quetiapine Fumarate API?

A: Standard laboratory safety practices should be employed, including the use of personal protective equipment such as gloves, safety goggles, and lab coats. Avoiding inhalation and direct contact is recommended as with any pharmaceutical raw material.

Q: When is the best time to use this API in the manufacturing process?

A: Quetiapine Fumarate API should be integrated during the compounding stage of pharmaceutical formulation, following validated protocols and quality checks to ensure product integrity and therapeutic performance.

Q: What are the key benefits of this Quetiapine Fumarate API for manufacturers?

A: Manufacturers benefit from its high purity (99%), low impurity levels, compliance with international microbial and heavy metal limits, and consistent physical characteristics, ensuring quality, safety, and efficacy of finished pharmaceutical products.

Q: Where is this API exported and supplied from?

A: This API is manufactured, supplied, and exported from India, a prominent hub for pharmaceutical production, ensuring global availability through reliable distribution networks.

Q: What is the process to verify the identity and purity of this API?

A: Identity is confirmed by advanced instrumental methods such as IR, UV, and HPLC, while purity and impurities are assessed via HPLC assay, guaranteeing compliance with regulatory standards.

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