- PRODUCT NAME:Prednisolone
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PRODUCT |
PREDNISOLONE |
DATE OF SAMPLING |
JAN.09,2023 |
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BATCH NUMBER |
K04120230106 |
DATE OF REPORT |
JAN.13,2023 |
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BATCH SIZE |
304.48 Kg |
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) |
SPECIFICATION |
RESULTS |
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APPEARANCE |
WHITE OR ALMOST WHITE CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
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IDENTIFICATION |
A:IR |
CONFORM |
CONFORM |
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B:HPLC |
CONFORM |
CONFORM |
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SPECIFIC OPTICAL ROTATION |
+113°~+119° |
+118° |
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RELATED SUBSTANCES |
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% |
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 |
≤1.0% |
0.1% |
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ASSAY |
96.5～102.0% (ON DRIED SUBSTANCE) |
99.1% |
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CONCLUSION: CONFORMS TO EP10.4 |
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RESIDUAL SOLVENTS |
METHANOL≤700PPM METHYLENE CHLORIDE≤600PPM |
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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1.What is Prednisolone?
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).
2.How it Works?
Prednisolone is metabolized in the body to form prednisolone. The impact of prednisolone on the liver is slightly smaller than that of prednisolone, but their pharmacological effects are the same. All of them are adrenal cortex hormone drugs with anti-inflammatory, anti allergic, anti rheumatic, and immunosuppressive effects.
3.Benefits and Uses
It's use for the treatment of a wide range of inflammatory and auto-immune conditions
Such as asthma,uveitis, pyoderma gangrenosum, rheumatoid arthritis, ulcerative colitis, temporal arteritis and Crohn's disease, Bell's palsy, multiple sclerosis
Cluster headaches, vasculitis, acute lymphoblastic leukemia and autoimmune hepatitis, systemic lupus erythematosus, and dermatomyositis.
It is also used for treatment of sarcoidosis, though.
4.Q&A
Q:Does the company accept sample orders?
A:Yes, our company accepts sample orders.
Q:What is the minimum order quantity for the company?
A:We do not have a minimum order quantity requirement, we arrange according to the customer's needs.
Q:How to ensure the quality of goods?
A:We have a strict QC/QA management system and strict release procedures, and we will provide all procedures to customers before shipment according to their requirements.
Q:Can we see the product quality before the order is shipped?
A:Of course, we always provide a relative Batach (s) 'COA before shipping.
Q:How will you deliver the goods?
A:We will communicate with customers, adopt their suggestions, arrange the most suitable delivery method, and ensure mutual satisfaction.
