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Prednisolone Acetate API

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MOQ : 25 Kilograms

Prednisolone Acetate API Specification

Structural Formula
C23H30O6

Taste
Slightly bitter

Ph Level
Neutral to slightly acidic (pH 5-7, in suspension)

Particle Size
Micronized, 90% <10 microns

Heavy Metal (%)
0.001%

Boiling point
Not applicable (decomposes)

EINECS No
200-134-1

Molecular Weight
402.48 g/mol

Loss on Drying
0.5%

Shelf Life
5 years from manufacturing date if properly stored

HS Code
29372200

Storage
Store in a tightly closed container, protected from light and moisture, at 2-8C

Color
White to off-white

Solubility
Very slightly soluble in water; freely soluble in chloroform, sparingly soluble in ethanol

Molecular Formula
C23H30O6

Poisonous
Non-poisonous at therapeutic dosages

Melting Point
238-240C

Smell
Odorless

Medicine Name
Prednisolone Acetate

Chemical Name
Prednisolone 21-acetate

CAS No
52-21-1

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in the manufacture of ophthalmic and systemic corticosteroid medications

Purity(%)
99.0

Appearance
White or almost white crystalline powder

Physical Form
Solid

Residual Solvents
Complies with ICH Q3C guidelines

Identification
Complies with standard IR/UV requirements

Assay
Not less than 99.0% and not more than 101.0% (on anhydrous basis)

Microbial limit
Total aerobic microbial count not more than 1000 CFU/g

Optical Rotation
+72 to +80 (in ethanol)

Bacterial endotoxins
0.25 IU/mg

Packaging
Double polyethylene bags placed in HDPE drum

Manufacturing Method
Fermentation and synthetic route

Related Substances
Total impurities 1.0%

USP Reference
USP/EP/BP/JP standards available

Prednisolone Acetate 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 Prednisolone Acetate API

Prednisolone Acetate API is a must-have pharmaceutical-grade active ingredient, renowned for its commanding efficacy and monumental purity (not less than 99.0%). Manufactured using redoubtable fermentation and synthetic methods, this crystalline white powder complies with USP/EP/BP/JP standards and exhibits new heights in safety, meeting strict microbial and endotoxin limits. The product undergoes rigorous characterization, including optical rotation (+72 to +80), assuring that it meets redoubtable standards. Redeem the assurance of quality-each batch comes securely packed in double polyethylene bags within an HDPE drum, ready to support the manufacture of trusted ophthalmic and systemic corticosteroid medicines.

Leading Features and Application Domains

Prednisolone Acetate API boasts precise micronized particle size (90% <10 microns) and monumental chemical stability, ensuring consistent performance in pharmaceutical manufacturing. Used extensively in the formulation of ophthalmic and systemic corticosteroid medications, this redoubtable API supports applications across hospitals, specialty clinics, and pharmaceutical industries. Its slightly bitter taste, white-to-off-white color, and odorless nature make it suitable for various dosage forms. Usage involves stringent adherence to neutral to slightly acidic pH and optimal storage conditions, safeguarding its efficacy and integrity.

Sample Accessibility, Accreditation, and Logistics Assurance

Experience seamless logistics and efficient handover with readily available Prednisolone Acetate API samples. Each batch is certified under USP/EP/BP/JP standards, granting monumental credibility to your production process. Our FOB port services from India guarantee the lowest price and on-time dispatch. Partner with a supplier committed to transparent documentation and quality assurance, ensuring you redeem uncompromising reliability throughout the supply chain.

FAQ's of Prednisolone Acetate API:

Q: How is Prednisolone Acetate API produced?

A: Prednisolone Acetate API is manufactured using a combination of fermentation and synthetic processes, ensuring robust quality and consistency for pharmaceutical applications.

Q: What are the recommended application areas for this API?

A: It is widely used in the production of ophthalmic and systemic corticosteroid medications, serving diverse areas such as hospitals, clinics, and pharmaceutical formulations.

Q: When should Prednisolone Acetate API be stored and handled?

A: This API should be stored in a tightly closed container, protected from light and moisture, at a temperature between 2-8C to maintain its stability and efficacy.

Q: Where can I obtain samples and certification documents for this product?

A: Samples and complete certification (USP/EP/BP/JP) are readily available through our export and supply network, with logistics organized through major Indian FOB ports.

Q: What are the main benefits of using Prednisolone Acetate API from your company?

A: Our Prednisolone Acetate API offers commanding purity, rigorous compliance with global standards, secure packaging, and dependable logistics-delivering monumental value and reliability to your production needs.

Q: How can I redeem the lowest price offer for bulk supply?

A: Contact our export team to discuss your requirements; we ensure the lowest price and optimal logistics with every bulk order, supported by full regulatory documentation.

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