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Nepafenac Micronised Sterile API

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MOQ : 25 Kilograms

Nepafenac Micronised Sterile API Specification

Heavy Metal (%)
<0.001%

Particle Size
Micronized; D90 <10 m

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

Shelf Life
36 months from date of manufacture

Color
Off-white to pale yellow

Melting Point
191-193C

Smell
Odorless

Molecular Formula
C15H14N2O2

Molecular Weight
254.29 g/mol

Boiling point
Not applicable (decomposes before boiling)

Taste
Not applicable for API

Ph Level
5.0 - 7.5 (for 1% aqueous solution)

Poisonous
Non-poisonous under recommended usage

Solubility
Practically insoluble in water, soluble in acetone and methanol

Loss on Drying
0.5%

Structural Formula
Provided on request or as per certificate of analysis

HS Code
29420090

Medicine Name
Nepafenac Micronised Sterile API

Chemical Name
Nepafenac

CAS No
78281-72-8

Type
API (Active Pharmaceutical Ingredient)

Grade
Pharmaceutical Grade

Usage
Used as a non-steroidal anti-inflammatory drug (NSAID) for ophthalmic preparations

Purity(%)
>=99% (by HPLC)

Appearance
Off-white to pale yellow powder

Physical Form
Powder

Impurity Profile
Individual impurity NMT 0.1%. Total impurities NMT 0.3% (by HPLC)

Residual Solvents
Complies with ICH guidelines

Endotoxin Limit
<0.25 EU/mg

Sterility
Sterile

Packaging
Double PE bag in aluminum drum or as required by customer specifications

Assay (by HPLC)
>=99%

Identification
Complies with standard Nepafenac reference standard (IR/UV/HPLC)

Microbial Load
Total aerobic microbial count NMT 100 cfu/g, Total yeast & mold count NMT 10 cfu/g, Absent for E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa

Nepafenac Micronised Sterile API Trade Information

Minimum Order Quantity
25 Kilograms

Payment Terms
Cash on Delivery (COD), Cash in Advance (CID), Cash Against Delivery (CAD)

Supply Ability
500 Kilograms Per Month

Delivery Time
5-7 Days

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

Main Domestic Market
All India

About Nepafenac Micronised Sterile API

Get the latest Nepafenac Micronised Sterile API for a limited time, offering world-class quality for pharmaceutical applications. This pristine, off-white to pale yellow powder boasts a towering purity of 99% by HPLC, making it ideal for ophthalmic NSAID formulations. It meets strict sterility standards with a total aerobic microbial count NMT 100 cfu/g and absent for major pathogens. Complying meticulously with ICH guidelines on residual solvents and heavy metals (<0.001%), this API is securely packaged in double PE bags within aluminum drums, ensuring integrity from supplier to destination.

Additional Applications and Usage Directions

Nepafenac Micronised Sterile API is primarily used in ophthalmic preparations as an effective non-steroidal anti-inflammatory agent. Specifically, its micronized particle size ensures optimal absorption and efficacy in eye drop formulations. To use, precisely follow the compounding protocols specified for sterile APIs within pharmaceutical production. Given its high purity and stringent quality controls, it is also adaptable for developing various ocular therapeutics beyond anti-inflammatory usage, upon consultation with formulation experts.

Delivery, Certifications, and Packaging Information

Benefit from our prompt delivery, with typical dispatches within a week at a competitive list price. Flexible payment and exchange options are available to meet your procurement needs. Every batch is delivered with a Certificate of Analysis and relevant exporting certifications, ensuring global compliance. Packaging includes a double PE bag in an aluminum drum or customized as required, safeguarding product integrity during transit and storage.

FAQ's of Nepafenac Micronised Sterile API:

Q: How should Nepafenac Micronised Sterile API be stored to maintain its quality?

A: It should be stored in a cool, dry place, protected from light and moisture, to preserve its sterility and chemical integrity.

Q: What is the main usage of Nepafenac Micronised Sterile API?

A: It is mainly used as an active ingredient in ophthalmic preparations, functioning as a non-steroidal anti-inflammatory drug (NSAID) for the treatment of eye inflammation.

Q: When can I expect delivery after placing an order?

A: Delivery is typically completed within a week, depending on quantity and specific requirements, with all batches accompanied by necessary certifications and documentation.

Q: Where does the quality assurance process take place for this API?

A: All quality assurance, including microbial and impurity testing, occurs at certified facilities in India, adhering to international pharmaceutical standards.

Q: What are the benefits of using micronised Nepafenac in formulations?

A: Micronised Nepafenac ensures enhanced solubility, improved bioavailability, and consistent dosing in ophthalmic products, contributing to superior therapeutic outcomes.

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