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Arshine Group Co.,Ltd.
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Prednisolone is a steroid medication used to treat certain types of allergies, inflammatory conditions, autoimmune disorders, and cancers. Some of these conditions include adrenocortical insufficiency, high blood calcium, rheumatoid arthritis, dermatitis, eye inflammation, asthma, and multiple sclerosis. It is used by mouth, injection into a vein, as a skin cream, and as eye drops. Side effects with short term use include nausea and feeling tired. More severe side effects include psychiatric problems, which may occur in about 5% of people. Common side effects with long term use include bone loss, weakness, yeast infections, and easy bruising. While short term use in the later part of pregnancy is safe, use long term or early in early pregnancy is occasionally associated with harm to the baby. It is a glucocorticoid made from hydrocortisone (cortisol).
1.It's use for the treatment of a wide range of inflammatory and auto-immune conditions
2.Such as asthma,uveitis, pyoderma gangrenosum, rheumatoid arthritis, ulcerative colitis, temporal arteritis and Crohn's disease, Bell's palsy, multiple sclerosis
3. Cluster headaches, vasculitis, acute lymphoblastic leukemia and autoimmune hepatitis, systemic lupus erythematosus, and dermatomyositis.
4. It is also used for treatment of sarcoidosis, though.
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PRODUCT
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PREDNISOLONE
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DATE OF SAMPLING
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JAN.09,2023
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BATCH NUMBER
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K04120230106
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DATE OF REPORT
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JAN.13,2023
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BATCH SIZE
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304.48 Kg
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MANUFACTURING DATE: JAN.06,2023 RETEST DATE: DEC.2027
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CRITERIA: EP10.4
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NAME OF THE TEST
(METHOD)
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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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WHITE CRYSTALLINE POWDER
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IDENTIFICATION
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A:IR
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CONFORM
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CONFORM
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B:HPLC
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CONFORM
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CONFORM
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SPECIFIC OPTICAL ROTATION
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+113°~+119°
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+118°
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RELATED SUBSTANCES
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IMPURITY A≤1.0%
IMPURITY B≤0.30%
IMPURITY C≤0.30%
IMPURITY F≤0.50%
IMPURITY J≤0.30%
UNSPECIFIED IMPURITY≤0.10%
TOTAL≤1.5%
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IMPURITY A: 0.73%
IMPURITY B: 0.05%
IMPURITY C: <0.05%
IMPURITY F: <0.05%
IMPURITYJ <0.05%
UNSPECIFIED IMPURITY:
RRT(0.93)0.07%
TOTAL:0.85%
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LOSS ON DRYING
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≤1.0%
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0.1%
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ASSAY
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96.5～102.0%
(ON DRIED SUBSTANCE)
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99.1%
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CONCLUSION: CONFORMS TO EP10.4
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RESIDUAL SOLVENTS
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METHANOL≤700PPM
METHYLENE CHLORIDE≤600PPM
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NOT DETECTED
84PPM
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MICRONIZED
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STORAGE: STORE IN AN AIRTIGHT CONTAINER, PROTECTED FROM LIGHT
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