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Sinoway Industrial Co.Ltd.
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Product name
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Hydrocortisone
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Molecular Formula
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C21H30O5
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Molecular Weight
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362.46
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CAS No.
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50-23-7
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Quality Standard
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99% up, medical grade
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Appearance
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White powder
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Items
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Specifications
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Results
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Appearance
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A white or almost white, crystalline powder
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White crystalline powder
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Solubility
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Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chloride
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Complies
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Identification
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A: IR-Spectrum
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Meets the requirement
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Complies
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B: HPLC
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Meets the requirement
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Complies
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Specific optical rotation
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Between+162°and +168°
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+165.4°
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Loss on drying
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Not more than 1.0%
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0.09%
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Related substances
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Impurity D RRT0.2
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Not more than 0.50%
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0.23%
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Impurity H RRT0.3
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Not more than 0.15%
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N.D
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Impurity I RRT0.5
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Not more than 0.50%
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0.17%
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Impurity M RRT0.7
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Not more than 0.10%
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0.09%
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Impurity G RRT0.8
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Not more than 0.40%
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0.08%
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Impurity E RRT0.86
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Not more than 0.50%
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0.09%
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Impurity A RRT0.96
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Not more than 0.20%
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0.09%
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Impurity B RRT1.1
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Not more than 0.20%
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N. D
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Impurity F RRT1.4
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Not more than 0.30%
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0.06%
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Impurity C RRT1.5
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Not more than 0.50%
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0.08%
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Impurity N RRT1.7
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Not more than 0.15%
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N.D
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Any unspecified impurity
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Not more than 0.10%
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Complies
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Sum of impurities
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Not more than 2.0%
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1.01%
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Assay
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Between 97.0% and 103.0%
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100.7%
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Residual solvents (in-house)
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Methanol
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Not more than 500ppm
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Not detect out
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Ethanol
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Not more than 2000ppm
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Not detect out
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Methylene chloride
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Not more than 600ppm
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Not detect out
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Chloroform
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Not more than 60ppm
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Not detect out
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Particle size (In-house )
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90% not more than 15micron
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Complies
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Conclusion
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The product conforms to Ph.Eur. 8.0
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Function of Hydrocortisone
1. Anti-inflammatory effect: The anti-inflammatory effect of hydrocortisone is 1.25 times that of cortisone, and it has inhibitory effect on infectious and non-infectious inflammation at pharmacological doses. Hydrocortisone can increase the tension of blood vessels, reduce congestion, and reduce the permeability of capillaries, thereby reducing exudation and edema; by inhibiting the accumulation of inflammatory cells (including macrophages and white blood cells) in the inflammation site, and inhibiting phagocytosis The function of the cell stabilizes the lysosomal membrane, prevents complement from participating in the inflammatory response and the synthesis and release of inflammatory chemical mediators (such as prostaglandins, thromboxanes, and leukotrienes), thereby alleviating redness, swelling, heat, pain and other symptoms.
2. Immunosuppressive effects: The effects of hydrocortisone, including preventing or suppressing cell-mediated immune responses, delayed allergic reactions, reducing the number of T lymphocytes, monocytes, and eosinophils, and reducing the binding of immunoglobulins to cell surface receptors It also inhibits the synthesis and release of interleukins, thereby reducing the transformation of T lymphocytes into lymphoblasts and reducing the expansion of the primary immune response. Hydrocortisone and other glucocorticoid drugs can also reduce the passage of immune complexes through the basement membrane, and reduce the concentration of complement components and immunoglobulins; it can relieve the symptoms of many allergic diseases and inhibit the pathology caused by allergic reactions Changes, such as allergic congestion, edema, exudation, skin rash, smooth muscle spasm and cell damage, can inhibit transplant rejection of tissues and organs, and can also exert certain short-term effects on autoimmune diseases.
3. Antitoxin effect: Hydrocortisone and other glucocorticoids can improve the body's stress ability to harmful stimuli, reduce the damage of bacterial endotoxin to the body, alleviate the symptoms of toxemia, and reduce fever caused by infectious toxemia. effect. The antipyretic mechanism may be related to its inhibition of the response of the body temperature center to pyrogens, stabilization of the lysosome membrane, and reduction of the release of endogenous pyrogens.
4. Anti-shock effect: Hydrocortisone and other glucocorticoids have antagonistic effects on toxic shock, hypovolemic shock, and cardiogenic shock. The anti-shock effect is related to the following factors: (1) dilates the constricted blood vessels and excites the heart, strengthens the contractility of the heart; (2) inhibits the production of certain inflammatory factors, reduces the systemic inflammatory response syndrome and tissue damage, makes micro Circulating hemodynamics return to normal, improving the state of shock; (3) Stabilize the lysosome membrane and reduce the formation of myocardial inhibitors; (4) Improve the body's tolerance to bacterial endotoxins.
5. Effects on metabolism: (1) Increase liver glycogen and increase blood sugar by promoting gluconeogenesis, slowing down glucose decomposition, reducing the use of glucose by body tissues, etc.: (2) Increasing protein decomposition Metabolism increases the excretion of serum amino acids and urine nitrogen, resulting in a negative nitrogen balance. And large doses can also inhibit protein synthesis; (3) It can increase plasma cholesterol, activate the esterases under the skin of the limbs, and promote the decomposition of subcutaneous fat, which is redistributed on the face, upper chest, back of the neck, abdomen and buttocks, forming central obesity: (4) Hydrocortisone has a certain mineralocorticoid-like effect, which can enhance the reabsorption of sodium ions and the excretion of potassium, calcium and phosphorus.
6. Effect on blood and hematopoietic system: Hydrocortisone can stimulate the hematopoietic function of bone marrow, increase the content of red blood cells and hemoglobin, large doses may increase platelets and increase the concentration of fibrinogen, and shorten the clotting time. In addition, Hydrocortisone can reduce eosinophils and lymphocytes in the blood.
7. Others: Hydrocortisone can reduce the pathological hyperplasia of connective tissue, improve the excitability of the central nervous system, promote gastric acid and pepsin secretion, etc. |
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