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Prednisolone
Prednisolone
CAS No.:50-24-8
Molecular Formula:C21H28O5
Molecular Weight:360.44
PRODUCT NAME: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).

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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