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Entacapone API

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Entacapone API Specification

Molecular Formula
C14H15N3O5

Water Cotent
0.5% or 1%

Form
Powder

Purity
High

Grade
Pharmaceutical Grade

Shelf Life
1 Years

Function
used as an adjunct to levodopa/carbidopa in tablets to increase plasma levels of levodopa.

Color
Yellow, crystalline powder

Storage Instructions
Cool & dry place

Entacapone API Trade Information

FOB Port
MUMBAI

Payment Terms
Paypal, Cash Advance (CA), Cash in Advance (CID), Telegraphic Transfer (T/T), Western Union

Delivery Time
2-3 Week

Sample Policy
Sample costs shipping and taxes has to be paid by the buyer

Packaging Details
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

Main Domestic Market
All India

Certifications
WHO,GMP,COA,MSDS As Per Client Requirement

About Entacapone API

This medication is used with other medications (levodopa/carbidopa) to treat Parkinson disease. Entacapone belongs to a class of drugs known as COMT inhibitors.

Specification:

TEST	SPECIFICATION	RESULT
Appearance	Greenish yellow to yellow crystalline powder	Yellow crystalline powder
Identification by IR	Test IR spectrum should be concordant with reference spectrum	Complies
Solubility	Sparingly soluble in acetone and methanol; slightly soluble in ethanol, chloroform, isopropanol, and ether, very slightly soluble ; practically in water	Complies
Loss on drying	0.5%max	0.35%
Heavy metals	Not more than 20ppm	<20ppm
Residue on ingition	Not more than 0.1%	0.06%
Related substance Impurity A Other unknown impurity Total impurity except Impurity A	0.1%max 0.1%max 0.2%max	0.03% 0.03% 0.09%
Z-isomer	0.05%max	0.01%
Assay(on dry basis)	98.0%-102.0%	99.91%
Particle size	D90: less than 10microns	8microns
Storage	Cool and dry
Conclusion:	Up to the Standard of USP34

Packaging details:

Packaging details:	25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.
Storage:	Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat
Shelf Life:	5 years if sealed and store away from direct sun light.

Superior Pharmaceutical Grade Quality

Our Entacapone API is produced under stringent quality controls, ensuring pharmaceutical-grade purity exceeding 99%. The fine, yellow crystalline powder exhibits excellent batch consistency, consistently meeting international standards for active pharmaceutical ingredients. Its finely controlled particle size facilitates precise formulation and reliable therapeutic effects in end-product manufacturing.

Storage and Stability for Maximum Shelf Life

Entacapone API offers a robust shelf life of up to two years from the date of manufacturing when stored properly in a cool, dry environment. The careful packaging and storage guidelines help preserve its physical and chemical integrity, ensuring optimal potency throughout its shelf life for pharmaceutical manufacturers and distributors.

Usage as an Adjunct Therapy

This API is primarily used as an adjunct with levodopa/carbidopa in tablet formulations to increase plasma levels of levodopa, improving therapeutic outcomes for patients. Its reliable solubility in water and other solvents supports efficient incorporation into tablet and injectable systems, enhancing its value in pharmaceutical development and patient therapy.

FAQ's of Entacapone API:

Q: How is Entacapone API typically used in pharmaceutical preparations?

A: Entacapone API is most commonly employed as an adjunct to levodopa/carbidopa in tablets. Its primary role is to increase plasma levodopa levels, thereby enhancing its therapeutic effect for patients, particularly those with Parkinson's disease.

Q: What storage conditions are recommended for Entacapone API?

A: Entacapone API should be stored in a cool, dry place to maintain its stability and potency. Proper storage protects it from moisture and heat, ensuring a shelf life of up to two years from the date of manufacturing.

Q: Where can Entacapone API be sourced from?

A: This product is available through multiple channels including distributors, exporters, manufacturers, suppliers, traders, and wholesalers across India. Each supply channel follows stringent quality norms to deliver pharmaceutical-grade Entacapone.

Q: What are the physical and chemical properties of Entacapone API?

A: Entacapone is a yellow, crystalline powder with a bitter taste and fine particle size. Its purity exceeds 99%, with a loss on drying of only 0.5%. The melting point ranges between 271C to 273C, and it is soluble in water, ethanol, and chloroform.

Q: What benefits does Entacapone API offer in medicinal formulations?

A: In medicinal preparations, Entacapone API increases plasma levels of levodopa, leading to more consistent and enhanced therapeutic effects for patients using levodopa/carbidopa combination therapy, especially in the treatment of Parkinson's disease.

Q: How is the purity and safety of Entacapone API ensured during manufacturing?

A: The manufacturing process adheres to pharmaceutical-grade standards, ensuring a purity level of over 99% and heavy metal content below 0.001%. Regular testing for physical attributes, water content, and contaminants guarantees safety and efficacy.

Q: When should Entacapone API be used within its shelf life?

A: For optimal safety and effectiveness, Entacapone API should be used within one to two years from its manufacturing date, provided it is kept as per storage recommendations in a cool, dry environment.

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