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Product name
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Prednisolone Acetate;
Prednisolone 21-Acetate
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CAS No.
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52-21-1
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Molecular Formula
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C23H30O6
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Molecular Weight
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402.488
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Quality Standard
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97% -102%, EP/USP
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Appearance
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White or almost white crystalline powder
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ITEMS
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SPECIFICATION
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RESULTS
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Appearance
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White or almost white crystalline powder
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Almost white crystalline powder
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Specific rotation
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+112°~+119°
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+114.8°
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Identification
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A: complies by IR
B :complies by UV not more than 2.5%
C: positive reaction
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Conforms
0.6%
Conforms
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Chromatographlc purity
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Principal impurity not more than 1.0%
Total impurity not more than 2.0%
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0.43%
0.65%
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Methanol
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≤3000ppm
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406ppm
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Loss on drying
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Not more than 1.0%
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0.1%
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Assay
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Contains 97.0%~102.0% C23H30O6 calculated on dried basis
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100.0%
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Conclusion
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The product complies with USP34 standard
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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.
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Pharma Sources Insight June 2024: Globalization on the Go
