Method for determining the average molecular weight of methacrylic acid copolymers

Claims

1. A stable composition for the determination of carbohydrates in compositions containing biologically active substances, including sorbitol, mannitol, trehalose dihydrate, glucose, lactose, sucrose, maltose monohydrate, diluted with 0.05% sodium azide to a concentration of 25 mg / ml each, characterized by certified ranges of resolution factors between the peaks of carbohydrate pairs: sorbitol and mannitol 1,8-2,4 mannitol and trehalose 2,1-2,9 trehalose and glucose 5,3-6,7 glucose and lactose 8,9-12,1 lactose and sucrose 3,5-5,1 sucrose and maltose 9,2-13,2 2. A stable composition according to claim 1, characterized in that the compositions containing biologically active substances are biological medicinal products.

3. A method for preparing a stable composition according to paragraph 1, characterized in that the carbohydrates sorbitol, mannitol, trehalose dihydrate, glucose, lactose, sucrose, and maltose monohydrate are diluted step by step with 0.05% sodium azide to a concentration of 25 mg / ml of each component, after which they are filtered, poured into ampoules, and then stored in a place protected from light at a temperature of no more than 8°C, while an analysis is carried out on an ion chromatograph using a standard solution for comparison with a concentration of 25 μg / ml of the incoming carbohydrates and the stability of the composition according to paragraph 1 is assessed.

4. The method according to paragraph 3, further characterized in that the analysis is carried out on an ion chromatograph in an isocratic elution mode with a flow rate of 1.0 ml / min.

5. The method according to paragraphs 3 and 4, further characterized in that the analysis on the ion chromatograph is carried out with pulse amperometric detection.

6. The method according to paragraphs 3-5, further characterized in that the analysis on the ion chromatograph is carried out using a mobile phase of the composition: 160 mM sodium hydroxide solution.

7. The method according to paragraph 3, characterized in that the assessment of the appearance of the composition poured into ampoules according to paragraph 1 is carried out over a period of 14 months.

8. The method according to paragraph 3, characterized in that the incoming carbohydrates with a concentration of 25 μg / ml of the standard comparison solution are sorbitol, mannitol, trehalose dihydrate, glucose, lactose, sucrose, maltose monohydrate.

9. Use of a stable composition according to claim 1 for carrying out ion-exchange high-performance liquid chromatography.