Pharmaceutical grade poloxamer 188 sample pack 500g original packaging 102kg

Pharmaceutical-grade Poloxamer 188 samples are packed in 500 grams and 102kg in the original packaging.
【Check】The pH value is 1.
0g of this product, dissolved in 10ml of water, and then determined according to the law (General Rule 0631).
The pH value should be 5.
0 to 7.
5
.

The clarity and color of the solution Take the solution under the item of pH, and check according to the law (General Rule 0901 and General Rule 0902), it should be clear and colorless.
deeper
.

Oxyethylene takes the deuterated (or deuterated water, 1% sodium 4,4-dimethyl-4-silapentanesulfonate as the internal standard) containing tetramethylsilane of this product, 10% to 20% (g /ml) solution 0.
5 ~ 1.
0ml, put it into a nuclear magnetic resonance tube, add 1 drop of deuterated water, shake, and scan from 0 × 10-6 to 5 × 10-6 in the nuclear magnetic resonance instrument, using the direct comparison method Quantitatively, calculate the oxyethylene (EO) value as follows: EO=3300α/(33α+58) where α=(A2/A1)-1 A1 is the integral area of ​​the double peak at 1.
15×10-6, which represents oxygen The methyl group of propylene; A2 is the integral area of ​​the composite peak at (3.
2～3.
8)×10-6, representing CH2O of oxypropylene, oxyethylene and CHO of oxypropylene; EO is the proportion of oxyethylene in the whole molecular composition , should be 71.
5% to 74.
9%
.

　　Unsaturation Weigh about 15.
0g of this product after fine grinding, add 50ml of vinegar solution precisely, dissolve it completely under magnetic stirring, let stand for 30 minutes, shake intermittently, add 10g of sodium bromide crystals, and mix under magnetic stirring 2 minutes, immediately add 1ml of phenolphthalein indicator solution, titrate with methanol-made potassium hydroxide titration solution (0.
1mol/L), calibrate with blank test and initial acidity [take 15.
0g of poloxamer, add neutral methanol (to phenolphthalein indicator) After dissolving in 75ml of methanol, potassium hydroxide titration solution (0.
1mol/L) was used to neutralize the solution until it was neutral to the phenolphthalein indicator solution]
.

Calculate the degree of unsaturation (mmol/g) with the following formula, which should not exceed 0.
065mmol/g
.

　　Unsaturation = (V supply - V blank - V initial) N/W where V is the volume of methanol to potassium hydroxide titration solution (0.
1 mol/L) consumed by the test sample, blank and initial acidity, ml; N is the concentration of potassium hydroxide titration solution made from methanol, mol/L; W is the weight of the test sample, g
.

　　Take an appropriate amount of this product for the average molecular weight (approximately equivalent to molecular weight × 0.
002g), accurately weigh it, accurately add 25ml of phthalic anhydride-pyridine solution, add a little zeolite, heat to reflux for 1 hour, let it cool, rinse the condenser with pyridine Twice, 10ml each time, add 10ml of water, mix well, stopper for 10 minutes, accurately add 50ml of 0.
66mol/L sodium hydroxide solution, add 0.
5ml of phenolphthalein-pyridine solution (1→100), and use sodium hydroxide titration solution (0.
5mol/L) titration, microscopic pink color, no fading for 15 seconds, and the titration result is corrected by blank test, that is, it is obtained
.

Calculate the average molecular weight of the test product according to the following formula, which should be 9840-14600
.

　　Average molecular weight=2000W/[(BS)N] In the formula, W is the weight of the test sample, g; B is the volume of the sodium hydroxide titration solution (0.
5mol/L) consumed by the blank, ml; S is the hydroxide consumed by the test sample Volume of sodium solution (0.
5mol/L), ml;