Testicular hyaluronidase is a glycoprotein containing 5% mannose and 2.7% glucosamine. Optimum pH range is 4.5-6.0. The enzyme catalyzes the hydrolysis of endo-N-acetylhexosaminic bonds of hyaluronic acid and chondroitin sulfate A and C (but not B), primarily to tetrasaccharide residues.
This product is an enzyme extracted from mammalian testis that can hydrolyze hyaluronic acid mucopolysaccharides. The activity of hyaluronidase per 1mg shall not be less than 300 units.
1. System requirements
This product should be extracted from mammalian testes that have passed the quarantine inspection, and the production process meets the requirements of the current version of the “Pharmaceutical Production Quality Management Code”.
This product is white to slightly yellow powder; odorless.
This product is easily soluble in water, but insoluble in ethanol, acetone or ether.
Take an appropriate amount of this product, dissolve it in water and make a solution containing 3mg per 1ml. According to law, the pH value should be 4.5-7.5.
4. The clarity and color of the solution
Take 0.1g of this product, add 10ml of water to dissolve, and check according to the law. The solution should be clear and colorless; if the color develops, it should not be deeper than the yellow No. 4 standard colorimetric solution.
Take an appropriate amount of this product, dissolve it in water and make a solution containing 300 units per 1ml. Measured by UV-Vis spectrophotometry. The absorbance at the wavelength of 280nm shall not be greater than 0.6; the absorbance at the wavelength of 260nm shall not be greater than 0.42.
6. Loss on drying
Take about 0.1g of this product and place it in a phosphorus pentoxide dryer to dry under reduced pressure for 4 hours, and the weight loss should not exceed 5.0%.
7. Tyrosine content
The tyrosine content per unit shall not exceed 0.1μg.
8. Abnormal toxicity
According to the pharmacopoeia method, it meets the requirements. Take 5 healthy mice weighing 17-22g, and subcutaneously inject 0.25ml of sodium chloride injection containing 10000 units of hyaluronidase per 1ml. No necrosis or death of subcutaneous tissues should occur within 48 hours. If the mouse has tissue necrosis or death, it should be retested according to the above method. All mice shall not have tissue necrosis or death within 48 hours.
9. Bacterial endotoxin
Take this product and check according to the law, the amount of endotoxin contained in 1 unit of hyaluronidase should be less than 0.20EU.
Product name: hyaluronidase
Specific activity: ≥300 u/mg pro
Packaging: 1g，5g,100g tube or bottle or bag etc
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