Difluprednate Active Pharmaceutical Ingredients

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Difluprednate Active Pharmaceutical Ingredients

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MOQ : 25 Kilograms

Difluprednate Active Pharmaceutical Ingredients Specification

HS Code
29372900

Particle Size
D90 10 m

Melting Point
147C - 150C

Loss on Drying
0.5%

Color
White to off-white

Poisonous
NO

Heavy Metal (%)
0.001%

Structural Formula
Available on request

Molecular Formula
C27H34F2O7

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

Molecular Weight
508.55 g/mol

EINECS No
245-735-7

Solubility
Sparingly soluble in ethanol and acetone, insoluble in water

Smell
Odorless

Shelf Life
36 months

Medicine Name
Difluprednate

Chemical Name
Difluprednate

CAS No
23674-86-4

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
For ophthalmic use; treatment of inflammation and pain associated with ocular surgery

Purity(%)
>99%

Appearance
White to off-white powder

Physical Form
Powder

Microbial Limits
Complies with pharmacopeial standard

Specific Optical Rotation
+35 to +43 (in methanol)

Monograph Compliance
USP, EP, BP

Residue on Ignition
0.1%

Packing
Double polyethylene bags placed in fiber drum or as requested

Residual Solvents
As per ICH Q3C guidelines

Packaging Size
1 kg, 5 kg, 10 kg or as required

Stability
Stable under recommended storage conditions

Peroxide Value
5.0 meq/kg

Regulatory Status
USDMF/EDMF available

Identification
Complies with standard reference

Manufacturing Process
Synthetic, per GMP guidelines

Related Substances
1.0%

Impurity Profile
As per pharmacopeia

Difluprednate Active Pharmaceutical Ingredients Trade Information

Minimum Order Quantity
25 Kilograms

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

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 Difluprednate Active Pharmaceutical Ingredients

Experience the unmatchable quality of Difluprednate Active Pharmaceutical Ingredients from India's formidable exporter, supplier, and trader. Our pharmaceutical-grade Difluprednate delivers >99% purity, cost-effective solutions, and stability, supported by USDMF/EDMF registration. Complying with USP, EP, and BP monographs, it features a special rate for bulk orders-shop now for the ultimate value. Packaged securely per international standards, this API is your trusted choice for ophthalmic applications, manufactured synthetically under strict GMP regulations for superior efficacy and safety.

Key Applications, Directions, and Special Features

Difluprednate API is primarily used in ophthalmic formulations for treating inflammation and pain related to ocular surgery. For optimal results, it should be formulated and administered as directed by healthcare professionals. Noteworthy features include its high purity, compliance with global pharmacopeial standards, and outstanding stability. Its white to off-white powder form, odorless nature, and sparing solubility profile ensure ease of formulation across diverse pharmaceutical requirements.

Certifications, Sample Policy, and Shipping Details

This API holds valued certifications such as USDMF and EDMF, enhancing its market valuation and regulatory acceptability. It is shipped securely from leading Indian FOB ports, tailored to meet your logistical requirements. Samples of Difluprednate are available; applicable charges may apply. Each batch is comprehensively tested and comes with detailed documentation, ensuring confidence in our supply and supporting your business's compliance needs.

FAQ's of Difluprednate Active Pharmaceutical Ingredients:

Q: How is Difluprednate API typically used in pharmaceutical formulations?

A: Difluprednate API is formulated primarily for ophthalmic use, especially in medications designed to treat inflammation and pain following ocular surgery. It should be incorporated into products as per pharmaceutical guidelines and under the supervision of qualified professionals.

Q: What are the key benefits of using Difluprednate from your facility?

A: Our Difluprednate boasts unmatchable purity (>99%), ultimate compliance with USP, EP, and BP monographs, and reliable, cost-effective supply. It is manufactured under strict GMP conditions, offering documented safety, stability, and regulatory support.

Q: Where is this API shipped from, and what packaging options are available?

A: Our Difluprednate is shipped from major FOB ports in India, securely packaged in double polyethylene bags within fiber drums. Packaging sizes of 1 kg, 5 kg, and 10 kg are available, with customized packing options to suit specific requirements.

Q: What is the process for acquiring product samples, and are there charges?

A: Product samples of Difluprednate are available upon request. Some charges may apply, depending on the requested quantity and destination. All samples are professionally packed and accompanied by the necessary technical documents.

Q: How does this API comply with global regulatory and impurity standards?

A: Difluprednate from our facility complies fully with USDMF/EDMF, meets current pharmacopeial standards for impurity profile, microbial limits, and residual solvents, and circulates with all required documentation.

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