Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Block 14, No.100, Luyun Road, Changsha 410205, Hunan, China.

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

  • Sample Provided: no

    Payment Terms: L/C

    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.

    PRODUCT

    PREDNISOLONE

    DATE OF SAMPLING

    JAN.09,2023

    BATCH NUMBER

    K04120230106

    DATE OF REPORT

    JAN.13,2023

    BATCH SIZE

     

    304.48 Kg

    MANUFACTURING DATE: JAN.06,2023 RETEST DATE: DEC.2027

    CRITERIA:                         EP10.4

    NAME OF THE TEST

    (METHOD)

    SPECIFICATION

    RESULTS

    APPEARANCE

    WHITE OR ALMOST WHITE CRYSTALLINE POWDER

    WHITE CRYSTALLINE POWDER

     

    IDENTIFICATION

    A:IR

    CONFORM

    CONFORM

    B:HPLC

    CONFORM

    CONFORM

    SPECIFIC OPTICAL ROTATION

    +113°~+119°

    +118°

     

     

     

    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%

    LOSS ON DRYING

    ≤1.0%

    0.1%

    ASSAY

    96.5~102.0%

    (ON DRIED SUBSTANCE)

    99.1%

    CONCLUSION: CONFORMS TO EP10.4

    RESIDUAL SOLVENTS

    METHANOL≤700PPM

    METHYLENE        CHLORIDE≤600PPM

    NOT DETECTED

    84PPM

    MICRONIZED

    STORAGE:  STORE IN AN AIRTIGHT CONTAINER, PROTECTED FROM LIGHT

     

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