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EP/USP standard Prednisolone Acetate 52-21-1
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更新 2025-08-13 22:05
 
详细信息

Grade: Pharmaceutical Grade

Factory Location: Xiamen

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Monthly Production Capacity: 10tons/year

Contract Manufacturing: CRO,CMO

Packaging Information: 25kg/bag

Delivery Lead Time: 7 days after payment

Sample Provided: yes

Payment Terms: L/C

Product Information

 

Product name

Prednisolone Acetate;

Prednisolone 21-Acetate

CAS No.

52-21-1

Molecular Formula

C23H30O6

Molecular Weight

402.488

Quality Standard

97% -102%, EP/USP

Appearance

White or almost white crystalline powder

 

COA

ITEMS

SPECIFICATION

RESULTS

Appearance

White or almost white crystalline powder

Almost white crystalline powder

Specific rotation

+112°~+119°

+114.8°

Identification

A: complies by IR

B :complies by UV not more than 2.5%

C: positive reaction

Conforms

0.6%

Conforms

Chromatographlc purity

Principal impurity not more than 1.0%

Total impurity not more than 2.0%

0.43%

0.65%

Methanol

≤3000ppm

406ppm

Loss on drying

Not more than 1.0%

0.1%

Assay

Contains 97.0%~102.0% C23H30O6 calculated on dried basis 

100.0%

Conclusion

The product complies with USP34 standard

 

Usage

 

The function of prednisone acetate:

Prednisone acetate is a corticosteroid medication that is used to treat a wide range of conditions, including allergic reactions, inflammatory diseases, autoimmune disorders, and certain types of cancer. It works by suppressing the immune system and reducing inflammation in the body.

 

Specifically, prednisone acetate:

(1)     Reduces inflammation in the body by suppressing the production of inflammatory chemicals.

(2)     Suppresses the immune system, which can help in treating autoimmune diseases where the immune system attacks healthy cells.

(3)     Provides relief from allergic reactions and other hypersensitivity reactions.

(4)     Used in combination with other medications to treat certain types of cancer.

 

The finished dosage form of prednisone acetate:

(1)   Prednisone Acetate Tablets: It is mainly used for the treatment of allergic and autoimmune inflammatory diseases, such as bronchial asthma, dermatomyositis, vasculitis, acute leukemia, and malignant lymphoma.

(2)   Prednisolone Acetate Cream: It is mainly used for the treatment of allergic, non-infectious skin diseases, and some proliferative skin disorders, such as dermatitis, eczema, neurodermatitis, seborrheic dermatitis, and pruritus.

(3)   Prednisolone Acetate Eye Drops: It is suitable for short-term treatment of steroid-sensitive ocular inflammation, excluding infections caused by viral, fungal, and bacterial pathogens.