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 Microcrystalline cellulose UF-702

Weijing Xianweisu

Microcrystalline Cellulose

COC1C(CO)OC2C(CO)OC(C(O)C(O)C2O)C1OOOHOOHOOHOHOHOH
C 6 n H 10 n + 2 O 5 n + 1 [ 9004 − 34 − 6 ] C 6 n H 10 n + 2 O 5 n + 1 [ 9004 − 34 − 6 ] {:[C_(6n)H_(10 n+2)O_(5n+1)],[[9004-34-6]]:}\begin{array}{r} \mathrm{C}_{6 \mathrm{n}} \mathrm{H}_{10 n+2} \mathrm{O}_{5 \mathrm{n}+1} \\ {[9004-34-6]} \end{array}

This strain is made from the fiber pulp of cellulose-containing plants, which is partially depolymerized and purified under the action of α α alpha\alpha inorganic acids.
 【Properties】This product is white or off-white powder or granular powder.

【Identification】(1) take 10 mg of this product, put it on the surface dish, add 2 ml of zinc chloride iodine test solution, and it will turn blue.

(2) take about 1.3 g of this product, weigh it accurately, place it in an Erlenmeyer flask with a stopper, add 25 ml of water accurately, shake to disperse and wet the microcrystalline cellulose, introduce nitrogen gas to exclude the air in the bottle, and under the condition of maintaining nitrogen gas, add 25 ml of copper 1 mol / L 1 mol / L 1mol//L1 \mathrm{~mol} / \mathrm{L} dihydroxide ethylenediamine solution to remove the nitrogen tube, plug it, and shake it vigorously to completely dissolve the microcrystalline cellulose as a test solution; Take an appropriate amount, put it in a 25 ∘ C ± 0.1 ∘ C 25 ∘ C ± 0.1 ∘ C 25^(@)C+-0.1^(@)C25^{\circ} \mathrm{C} \pm 0.1^{\circ} \mathrm{C} water bath, about 5 minutes later, move it to the Udss viscometer (the inner diameter of the capillary is , 0.8 ∼ 0.9 mm 0.8 ∼ 0.9 mm 0.8∼0.9mm0.8 \sim 0.9 \mathrm{~mm} select the appropriate viscometer constant K 1 K 1 K_(1)\mathrm{K}_{1} ), and measure it in a 25 ∘ C ± 0.1 ∘ C 25 ∘ C ± 0.1 ∘ C 25^(@)C+-0.1^(@)C25^{\circ} \mathrm{C} \pm 0.1^{\circ} \mathrm{C} water bath according to the millet determination method (Chinese Pharmacopoeia 2020 Edition Part IV General Chapter 0633 Second Method). Record the time t 1 t 1 t_(1)t_{1} (in seconds) when the test solution flows through the upper and lower scales of the test gauge, and calculate the kinematic viscosity of the test solution as follows v 1 v 1 v_(1)v_{1} :
v 1 = t 1 × k 1 v 1 = t 1 × k 1 v_(1)=t_(1)xxk_(1)v_{1}=t_{1} \times k_{1}

Take 25 ml of water and copper 1 mol / L 1 mol / L 1mol//L1 \mathrm{~mol} / \mathrm{L} dihydroxide ethylenediamine solution respectively, mix well, use as a blank solution, take an appropriate amount, put it in a 25 ∘ C ± 0.1 ∘ C 25 ∘ C ± 0.1 ∘ C 25^(@)C+-0.1^(@)C25^{\circ} \mathrm{C} \pm 0.1^{\circ} \mathrm{C} water bath, about 5 minutes, move it to the Shou's meter (the inner diameter of the capillary is K 2 K 2 K_(2)\mathrm{K}_{2} , 0.5 ∼ 0.6 mm 0.5 ∼ 0.6 mm 0.5∼0.6mm0.5 \sim 0.6 \mathrm{~mm} the viscometer constant is about 0.01), and measure it in a 25 ∘ C ± 0.1 ∘ C 25 ∘ C ± 0.1 ∘ C 25^(@)C+-0.1^(@)C25^{\circ} \mathrm{C} \pm 0.1^{\circ} \mathrm{C} water bath according to the roughness determination method (the second method of the four general rules of the fourth part of the 2020 edition of China Yaoyi). Record the time t 2 t 2 t_(2)\mathrm{t}_{2} (in seconds) of the blank solution flowing through the upper and lower scales of the gauge and calculate the kinematic viscosity of the blank solution as follows V 2 V 2 V_(2)\mathrm{V}_{2} :
v 2 = t 2 × k 2 v 2 = t 2 × k 2 v_(2)=t_(2)xxk_(2)v_{2}=t_{2} \times k_{2}

The relative salidity η rel η rel  eta_("rel ")\eta_{\text {rel }} of microcrystalline cellulose is calculated according to the following formula
η rel = v 1 / v 2 η rel = v 1 / v 2 eta_(rel)=v_(1)//v_(2)\eta_{\mathrm{rel}}=\mathrm{v}_{1} / \mathrm{v}_{2}

According to the calculated relative degree value η rel η rel eta_(rel)\eta_{\mathrm{rel}} , check the schedule of the four parts of the Chinese Pharmacopoeia 2020 edition of "microcrystalline cellulose", and obtain C ( g / 100 ml ) C ( g / 100 ml ) C(g//100ml)\mathrm{C}(\mathrm{g} / 100 \mathrm{ml}) the [ η ] c [ η ] c [eta]_(c)[\eta]_{\mathrm{c}} product of the number of characteristics [ η ] ( ml / g ) [ η ] ( ml / g ) [eta](ml//g)[\eta](\mathrm{ml} / \mathrm{g}) and concentration}, and calculate the degree of polymerization according to the following formula ( P ) ( P ) (P)(\mathrm{P}) , which should not exceed 350.
P = 95 [ η ] C m [ ( 100 − b ) / 100 ] P = 95 [ η ] C m [ ( 100 − b ) / 100 ] P=(95[eta]C)/(m[(100-b)//100])\mathrm{P}=\frac{95[\eta] \mathrm{C}}{m[(100-b) / 100]}

where m m mm is the sample amount of the test sample (g), and b b bb the drying weight loss of the test product (percentage D o D o D_(o)\mathrm{D}_{\mathrm{o}} ).

【Check】Conductivity: take 5.0 g of this product, add 40 ml of water that is freshly boiled and cooled to room temperature, shake for 20 minutes, centrifuge,

Take the supernatant and determine it according 25 ∘ C ± 0.1 ∘ C 25 ∘ C ± 0.1 ∘ C 25^(@)C+-0.1^(@)C25^{\circ} \mathrm{C} \pm 0.1^{\circ} \mathrm{C} to law (Chinese Pharmacopoeia 2020 Edition Part IV General Principles 0681), and determine the conductivity of the water used to prepare the test solution by the same method 75 μ S / cm 75 μ S / cm 75 muS//cm75 \mu \mathrm{~S} / \mathrm{cm} , and the difference between the two shall not be exceeded.

pH: take the supernatant prepared under the conductivity item, and determine it according to law (Chinese Pharmacopoeia 2020 Edition Part IV General Chapter 0631), pH value should be 5.0 ∼ 7.5 5.0 ∼ 7.5 5.0∼7.55.0 \sim 7.5 .

Solubility: take 50 mg of the test sample and dissolve it in 10 ml of tetraaminocupron solution, stirring constantly, it should be completely dissolved without residue.

Dissolved matter in water: take 5.0 g of this product, add 80 ml of water, vibrate for 10 minutes, stand at room temperature for 10~20 minutes, vacuum filtration (using microporous filter membrane 2 μ m 2 μ m 2mum2 \mu \mathrm{~m} or quantitative analysis filter paper with pore size or below), the filtrate 105 ∘ C 105 ∘ C 105^(@)C105^{\circ} \mathrm{C} is dried to a constant weight evaporation dish, steamed and dried on a water bath, and 105 ∘ C 105 ∘ C 105^(@)C105^{\circ} \mathrm{C} dried for 1 hour, and the residue must not be over 0.2 % 0.2 % 0.2%0.2 \% .

Dissolved matter in ether: take 10.0 g of this product, put it in a glass column with an inner diameter of about 20 mm, use 50 ml of ethylene without peroxide to elution column, collect the eluent and volatilize it in an evaporation dish that 105 ∘ C 105 ∘ C 105^(@)C105^{\circ} \mathrm{C} is dried to constant weight, and the residue left after 105 ∘ C 105 ∘ C 105^(@)C105^{\circ} \mathrm{C} drying to constant weight shall not be excessive 0.05 % 0.05 % 0.05%0.05 \% .

Loss on drying: take 1.0 g of this product, 105 ∘ C 105 ∘ C 105^(@)C105^{\circ} \mathrm{C} dry it for 3 hours, and determine it according to law (Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0831), weight loss shall not be 7.0 % 7.0 % 7.0%7.0 \% exceeded.

Residue on ignition: take 1.0 g of this product, check according to law (Chinese Pharmacopoeia 2020 Edition Part IV General Principles 0841), and the residual residue shall not be excessive 0.10 % 0.10 % 0.10%0.10 \% .

Heavy metals: take the residue left under the item of ignition residue and inspect it according to law (Chinese Pharmacopoeia 2020 Edition Part IV General Principles 0821 Second Law), containing heavy metals shall not exceed 0.0010 % 0.0010 % 0.0010%0.0010 \% .

Chloride: take 0.10 g of this product, add 35 ml of water, shake, filter, take the filtrate, check according to law (Chinese Pharmacopoeia 2020 Edition Four General Principles 0801), compared with the control solution made of 3.0 ml of standard sodium chloride solution, it shall not be more concentrated ( 0.03 % 0.03 % 0.03%0.03 \% ).

Starch: take 0.10 g of this product, add 5 ml of water, shake, and add 0.2 ml of iodized test solution, and it shall not be blue.

Arsenic salt: take 1.0 g of this product, add 1.0 g of calcium hydroxide, mix, add water and stir evenly, after drying, first burn with low heat to carbonize, and then completely ash in 600 ∘ C 600 ∘ C 600^(@)C600^{\circ} \mathrm{C} cautery, let cool, add 5 ml of hydrochloric acid and 23 ml of water to dissolve, check according to law (Chinese Pharmacopoeia 2020 Edition of the Fourth General Principles 0822 First Law), should comply with the provisions (shall not pass 0.0002 % 0.0002 % 0.0002%0.0002 \% ).

 Microbiological Limits:


Total aerobic bacteria (TAMC) must not be exceeded 1000 cfu / g 1000 cfu / g 1000cfu//g1000 \mathrm{cfu} / \mathrm{g} ;

The total number of scorpion and yeast (TYMC) shall not be exceeded 100 cfu / g 100 cfu / g 100cfu//g100 \mathrm{cfu} / \mathrm{g} ;
 Escherichia coli: 1 g undetected;
 Staphylococcus aureus: 1 g undetectable;
 Pseudomonas aeruginosa: 1 g undetectable;
 Salmonella: 10 g not detectable

Bulk density: weigh the weight of the calibrated qualified density container, feed through the feeding port of the powder comprehensive characteristics tester, stop feeding after the sample overflows, scrape the excess sample with a scraper and weigh it, repeat three times to take the average value of the weight, and calculate the bulk density. The bulk density of 0.22 − 0.35 g / mol 6 0.22 − 0.35 g / mol 6 0.22-0.35g//mol_(6)0.22-0.35 \mathrm{~g} / \mathrm{mol}_{6} this product should be

Particle size distribution: weigh this product to be determined according to law (Chinese Pharmacopoeia 2020 Edition Part IV General Chapter 0982, the third method light scattering method dry method), Malvern laser particle size analyzer dry determination (volume method) particle size distribution should be: D 10 = 15 − 55 μ m D 10 = 15 − 55 μ m D 10=15-55 mumD 10=15-55 \mu \mathrm{~m} , D 50 = 80 − 140 μ m , D 90 = 170 − 283 μ m D 50 = 80 − 140 μ m , D 90 = 170 − 283 μ m D 50=80-140 mum,D 90=170-283 mumD 50=80-140 \mu \mathrm{~m}, ~ D 90=170-283 \mu \mathrm{~m} .
 【Category】Pharmaceutical excipients, fillers and disintegrants, etc.
 【Storage】Sealed and stored.
 【Re-inspection period】 3 years.