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Clotrimazole API

Price 2100.0 INR/ Kilograms

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MOQ : 100 Kilograms

Clotrimazole API Specification

Heavy Metal (%)
NMT 20 ppm

Structural Formula
C22H17ClN2

Storage
Store in cool, dry place in tightly closed container

Melting Point
147C to 149C

Loss on Drying
Not more than 0.5%

Color
White to off-white

Particle Size
90% below 10 microns

Solubility
Practically insoluble in water; soluble in ethanol, and in acetone

Molecular Weight
344.84 g/mol

Smell
Odorless

Taste
Tasteless

Poisonous
Non-poisonous under recommended usage

Molecular Formula
C22H17ClN2

Shelf Life
5 years

HS Code
29332990

EINECS No
245-764-8

Medicine Name
Clotrimazole

Chemical Name
1-(o-Chloro-,-diphenylbenzyl)imidazole

CAS No
23593-75-1

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as antifungal agent in treatment of fungal skin infections

Purity(%)
99% minimum

Appearance
White to off-white, crystalline powder

Physical Form
Solid

Odor
Odorless

Residual Solvents
Complies with ICH Q3C guidelines

Water Content (by KF)
Not more than 0.1%

Manufacturing Standard
cGMP, USFDA, WHO-GMP compliant

Packaging
HDPE drums with double polyethylene bags, 25kg net weight

Risk Phrases
None under normal usage

Stability
Stable under recommended storage conditions

Bulk Density
0.350.45 g/cm

Identification
Meets USP/BP standards

Assay (by HPLC)
>=98.0%

Flash Point
>=165C (closed cup)

Related Substances
NMT 0.5%

End Use
Manufacture of creams, powders, and solutions for antifungal therapy

Clotrimazole 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 Clotrimazole API

Grade Standard	IP
Purity	Greater than 99%
Packaging Size	25Kg
CAS Number	23593 75 1
Packaging Type	Drum
Grade	Pharma Grade
Manufacturer	INDIAN
Chemical Formula	C22H17ClN2
Minimum Order Quantity	1000 Kg

Clotrimazole isia medication used in the management and treatment of fungal infections. It is in the imidazole class of drugs. This activity outlines the indications, action, and contraindications for clotrimazole as a valuable agent in the treatment of fungal infections.

Premium Quality and Purity

Clotrimazole API stands out with its high assay value (98%) and pharmaceutical grade, making it a trusted choice for anti-fungal applications. Its bulk density and particle size specifications ensure optimal formulation performance. Produced in state-of-the-art facilities in India, the product adheres to international standards and guidelines to guarantee consistent quality.

Compliant and Safe Manufacturing

The manufacturing and packaging processes strictly follow cGMP, USFDA, and WHO-GMP requirements, ensuring safety and reliability. Packed in HDPE drums with double polyethylene bags, the API is protected from moisture and contamination, maintaining chemical integrity throughout its shelf life.

Versatile Antifungal Applications

With its excellent solubility in ethanol and acetone, and practical insolubility in water, Clotrimazole API is suitable for a range of topical dosage forms. Its non-toxic and stable properties make it an ideal ingredient for creams, powders, and solutions designed to combat a variety of fungal skin infections.

FAQ's of Clotrimazole API:

Q: How is Clotrimazole API typically used in pharmaceutical manufacturing?

A: Clotrimazole API is used as the active ingredient in topical antifungal medications, including creams, powders, and solutions. It is formulated to effectively treat various fungal skin infections by pharmaceutical manufacturers.

Q: What are the quality standards and certifications for Clotrimazole API?

A: This API meets USP/BP identification standards, complies with ICH Q3C guidelines for residual solvents, and is produced in facilities certified for cGMP, USFDA, and WHO-GMP, ensuring high quality, safety, and regulatory compliance.

Q: When and how should Clotrimazole API be stored for maximum stability?

A: To ensure optimum stability and effectiveness, Clotrimazole API should be kept in a cool, dry place within tightly closed containers, away from moisture. Under recommended storage, it remains stable and effective for up to 5 years.

Q: Where does the packaging and supply of Clotrimazole API originate?

A: The production, export, and supply are managed by manufacturers in India. The product is securely packaged in 25 kg HDPE drums with double polyethylene bags to guarantee protection during shipping and storage.

Q: What is the process for ensuring the purity and safety of Clotrimazole API?

A: Clotrimazole API undergoes rigorous quality checks, including HPLC assay (98%), related substances analysis (NMT 0.5%), water content, and heavy metal limits. These tests, along with double-bagged packaging, maintain the API's purity and safety throughout its lifecycle.

Q: What benefits does Clotrimazole API offer for finished pharmaceutical products?

A: Its high purity, stability, and flexible solubility profile enable manufacturers to produce effective, non-toxic, and long-lasting topical antifungal medications with reliable therapeutic outcomes.

Q: Is Clotrimazole API poisonous or hazardous under normal usage?

A: Clotrimazole API is non-poisonous and presents no significant risk phrases when handled and used as recommended, making it safe for inclusion in standard topical antifungal treatments.

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