Identification and inspection method of Chondroitin Sulfate Sodium manufacturer?

  Chondroitin sulfate is a sulphated chain mucoglycan sodium salt extracted from pig cartilage such as laryngeal bone, nasal bone and trachea. Chondroitin sulfate is a sodium sulfate salt of copolymers of N-acetylgalactosamine (2-acetamide-2-deoxy -β -d-galactosyl) and D-glucuronic acid, in which hexose is alternately linked by β-1, 3 and β-1, 4 glycosidic bonds. Calculated as dry products, containing 95.0% ~ 105.0% chondroitin sulfate sodium (used for injection and eye drops); The content of chondroitin sulfate sodium was 85.0% ~ 105.0%(oral).

  Chondroitin Sodium Sulfate identification method :(1) the infrared absorption spectrum of this product should be consistent with that of Sodium Chondroitin Sulfate reference product. (2) The area ratio of chondroitin sulfate A to C should be 5.0-6.0 under the content determination of this product. (3) Identification of sodium salts in aqueous solution of the product (1) reaction.

Identification and inspection method of Chondroitin Sulfate Sodium manufacturer?

  Chondroitin Sulfate Sodium manufacturer This topic describes how to check Chondroitin Sulfate Sodium:

  Specific curl: take this product, weigh it accurately, dissolve in water, dilute quantitatively, and make a solution containing 40 mg per 1 ml. According to the method, the specific curl should be -28° to -33°.

  Acidity: take 0.5g of this product, dissolve in 10ml water, determine according to law. The pH value should be 6.0 to 7.0.

  Solution clarity and color: take 0.5g of the product, dissolve in 10ml water, the solution should be clear; If it is turbid, the absorbance should not be greater than 0.04 when measured at 640 nm wavelength by ultraviolet spectrophotometry. When developing color, it should not be deeper than yellow no. 2 standard liquid standard. (For injections and eye drops)

  Nitrogen content: the nitrogen content of this product is determined by nitrogen content determination method, and the nitrogen content of dry products should be 2.5% ~ 3.5%.

  Chloride: 0.1g chloride from the product, according to the chloride test method. Should be no thicker than a reference solution (0.5%) made from 5ml standard sodium chloride solution.

  Sulfate: 0.1g sulfate, according to the sulfate test method. Should be no thicker than a control solution (0.24%) made from 2.4 mL standard potassium sulfate solution. When the product is taken out from the loss during drying, the weight loss shall not exceed 10.0% after drying at 105℃ for 4 hours.

  Absorbance: the absorbance of this product is made into a solution containing 4 mg per 1 ml of water and determined by ultraviolet spectrophotometry. When the wavelength is 260 nm, the absorbance shall not be greater than 0.18; At wavelength 280 nm, the absorbance shall not be greater than 0.10. (For injections and eye drops)

  Burning residue: take 1.0g of this product, according to the burning residue test method. For dry products, the residue should be 20.0% ~ 30.0%.

  Heavy metal: the residue left under the incandescent residue shall be determined according to the heavy metal inspection method, and the heavy metal content shall not exceed 20 parts per million.

  Residual solvent: take this product, check according to law, ethanol content shall not exceed 0.5%.

  Bacterial endotoxin: use this product, check according to law. Bacterial endotoxin should be less than 0.5EU per 1 mg of chondroitin sulfate (for injection).