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Fluoxetine HCL IP

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MOQ : 5 Kilograms

Fluoxetine HCL IP Specification

Loss on Drying
0.5%

Heavy Metal (%)
0.001%

Molecular Formula
C17H18F3NO HCl

Storage
Store in a cool, dry place, protected from light

Place of Origin
India

Molecular Weight
345.79 g/mol

Boiling point
Not Applicable (decomposes before boiling)

HS Code
29224990

Melting Point
165-166 C

Residue on Ignition
0.1%

EINECS No
259-031-2

Assay
>=99% (on dried basis)

Ph Level
4.5 to 6.0 (1% solution)

Moisture (%)
0.5%

Particle Size
Not less than 90% passes through 60 mesh

Other Names
N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine hydrochloride

CAS No
56296-78-7

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Antidepressant, Treatment of major depressive disorder, Obsessive-compulsive disorder

Purity
>=99%

Appearance
White to off-white crystalline powder

Application
Pharmaceutical Intermediate, API

Raw Material
Synthesized Chemical

Smell
Odorless

Color
White

Form
Powder

Identification
Complies with IP/USP standard

Shelf Life
36 months

Sterility
Non-sterile

Optical Rotation
Not more than 1

Solubility
Freely soluble in water and alcohol

Endotoxin Level
NA (Not applicable for API raw material use)

Packaging
HDPE Drum / Double LDPE liner, 25 kg net

Residual Solvents
Complies with ICH guidelines

Related Substances
Maximum single impurity 0.1%

Microbial Limits
Total aerobic microbial count <1000 CFU/g, Yeast & moulds <100 CFU/g

TLC/Chromatography Purity
>99% by HPLC/TLC

Fluoxetine HCL IP Trade Information

Minimum Order Quantity
5 Kilograms

Payment Terms
Letter of Credit (L/C), Cash Against Delivery (CAD), Cash on Delivery (COD), Cash in Advance (CID), Cheque, Cash Advance (CA)

Supply Ability
10000 Kilograms Per Month

Delivery Time
15 Days

Sample Available
Yes

Main Domestic Market
All India

Certifications
GMP

About Fluoxetine HCL IP

These chemicals are antidepressant agents belonging to the selective serotonin reuptake inhibitors. We have uniquely positioned ourselves as a dependable firm, engaged in offering our clients Fluoxetine Chemicals. Our expert workforce uses superior grade compounds to process these chemicals. They are used to treat major depressive disorder (MDD), moderate to severe bulimia nervosa and obsessive-compulsive disorder (OCD). These chemicals are also effective in panic disorder with or without agoraphobia. Fluoxetine Chemicals are used in combination with olanzapine for treatment-resistant or bipolar I depression. These chemicals are packed in moisture proof containers and are available in different quantity packaging options.

FLUOXETINE:- Fluoxetine Hydrochloride is Benzenepropanmine, N-methyl- -[4-(trifluoromethyl) phenoxy]- ,hydrochloride

Formula: C₁₇H₁₈F₃NO,HCl

Category: Antidepressant.

Mol. Wt.: 345.79

Analysis	Specification
Description	White to off-white Crystalline Powder
Solubility	Sparingly soluble in water and in dichloromethane, freely soluble in alcohol and in methanol. Practically insoluble in ether.
Identification: A: B:	Byinfra-red absorption spectrum Gives the reactions ofchlorides,
Water	Not More than 0.5 %
Heavy Metals	Not more than 0.003 %
Sulphated Ash	Not more than 0.1%
Related Compound	Total impurities NMT 0.5 %
Organic Volatile Impurity	To Comply the test
Assay	Fluoxetine Hydrochloride contains not less than 98.0 per cent and not more than 102.0 per cent of:C17H18F3NO,HCl, calculated ontheanhydrous basis.

Superior Quality and Purity Assurance

Fluoxetine HCL IP complies with stringent quality benchmarks, including over 99% purity confirmed by HPLC/TLC chromatography. Meticulous controls on impurities, residual solvents, moisture content, and heavy metals ensure pharmaceutical-grade consistency and safety, making it suitable for critical medical applications.

Versatility in Formulation and Application

The products excellent solubility in water and alcohol, along with a finely controlled particle size (over 90% passing through 60 mesh), supports seamless integration into various dosage forms such as tablets and capsules. Its robust chemical stability enhances product shelf life up to 36 months when stored appropriately.

Robust Packaging and Global Standards

To preserve efficacy and integrity during transit and storage, Fluoxetine HCL IP comes securely packed in HDPE drums with double LDPE liners. Every batch is identified to comply with IP/USP pharma-grade requirements and meets international export standards, making it ideal for global pharmaceutical manufacturing.

FAQs of Fluoxetine HCL IP:

Q: How should Fluoxetine HCL IP be stored for optimal stability?

A: Fluoxetine HCL IP should be stored in a cool, dry place, protected from light, to maintain its 36-month shelf life and prevent degradation of its chemical properties.

Q: What pharmaceutical applications is Fluoxetine HCL IP suitable for?

A: This high-purity API is used primarily in the manufacture of antidepressant medications for major depressive disorder and obsessive-compulsive disorder, thanks to its regulatory compliance and excellent solubility.

Q: When does the product shelf life commence and what is its duration?

A: The 36-month shelf life begins from the date of manufacture, provided the product is kept in recommended storage conditions and remains in its original, tightly sealed packaging.

Q: Where is Fluoxetine HCL IP manufactured and what quality standards does it meet?

A: Fluoxetine HCL IP is manufactured in India and complies with IP and USP standards, ensuring it meets stringent pharmaceutical-grade quality requirements for global markets.

Q: What is the typical process for ensuring purity and safety in Fluoxetine HCL IP production?

A: Purity and safety are guaranteed through advanced synthesis techniques, extensive impurity profiling, consistent HPLC/TLC analysis, and adherence to ICH guidelines for residual solvents and stringent microbial limits.

Q: How can Fluoxetine HCL IP benefit pharmaceutical manufacturers?

A: With its high assay value (99%), low impurity content, robust packaging, and excellent solubility, it offers reliable consistency and maximizes formulation flexibility for pharmaceutical companies.

Q: What regulations and standards does Fluoxetine HCL IP adhere to for export?

A: It adheres to international standards, including IP/USP identification, ICH guidelines for residual solvents, and meets the HS Code 29224990, making it suitable for export and use worldwide as a pharmaceutical raw material.

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