Name | acetic acid, methanol, propane-1,2-diol, succinic acid |
Synonyms | Aqoat HyproMellose Acetate Succinate Hypromellose Acetate Succinate (100 mg) HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE Hydroxypropyl Methyl cellulose acetate succinate JPE acetic acid, methanol, propane-1,2-diol, succinic acid Cellulose,2-hydroxypropylmethylehter,acetatehydrogenbutanedioate |
CAS | 71138-97-1 |
InChI | InChI=1/C4H6O4.C3H8O2.C2H4O2.CH4O/c5-3(6)1-2-4(7)8;1-3(5)2-4;1-2(3)4;1-2/h1-2H2,(H,5,6)(H,7,8);3-5H,2H2,1H3;1H3,(H,3,4);2H,1H3 |
Molecular Formula | C10H22O9 |
Molar Mass | 286.276 |
Melting Point | >203°C (dec.) |
Boling Point | 236.1°C at 760 mmHg |
Flash Point | 110.9°C |
Solubility | Practically insoluble in ethanol (95%), hexane, unbufferedwater, and xylene. On the addition of acetone, or a mixtureof ethanol (95%) and dichloromethane (1 : 1), a clear or turbidviscous solution is produced. Hypromellose acetate succinatealso forms a clear or turbid solution in buffers of pH greater than4.5 with the rank order of solubility for the various grades increasing with the ratio of acetyl over succinoylsubstitution. The exact pH value at which the polymer starts toswell and dissolve |
Vapor Presure | 0.0165mmHg at 25°C |
Appearance | Solid |
Color | White to Off-White |
Storage Condition | Hygroscopic, -20°C Freezer, Under inert atmosphere |
Stability | Hygroscopic |
HS Code | 3912390000 |
This product is Hypromellose of acetic acid, succinic acid mixed ester. According to the calculation of the dried product, the methoxy group is 12.0% to 28.0%, the 2-hydroxypropoxy group is 4.0% to 23.0%, the acetyl group is 2.0% to 16.0%, and the succinyl group is 4.0% to 28.0%.
take 2.00g of this product (pre-dried), add sodium hydroxide solution to make 100g, shake for 30 minutes. The viscosity is measured at 20°C ± 0.1°C according to the law (General rule 0633 second method) and is 80%-120% of the indicated value.
take 0.102g of this product, precision weighing, Erlenmeyer flask, precision plus human phosphate solution (take 0.02mol/L potassium dihydrogen phosphate solution, adjust pH value to 7.5 with lmol/L sodium hydroxide solution) 4.0ml, stir for 2 hours, add 1.25 ml of phosphoric acid solution (take 4.0 mol/L phosphoric acid lm l, put it in a 50ml measuring flask, dilute it to the mark, shake it well), shake it strongly, centrifuge, and the supernatant is used as the test solution; Take 0.13g of succinic acid accurately, put it in a 100ml measuring flask, add appropriate amount of water, shake to completely dissolve, add water to the scale, shake well, as
It is a stock solution of succinic acid; Take a 100ml measuring flask with 20ml of water, weigh it, add 2ml of glacial acetic acid with precision, weigh it again, dilute it with water to the scale, shake it well, take 6ml with precision, prepare 4.0ml of acetic acid stock solution and ml of succinic acid stock solution, and place them in the same 25ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. Test according to high performance liquid chromatography (General 0512). The mobile phase was 0.02mol/L potassium dihydrogen phosphate solution (adjusted to pH 2.8 with 6moI/L phosphoric acid solution) with a flow rate of 1 ml per minute and a detection wavelength of 215nm. Take 10M1 of the control solution and inject it into human liquid chromatograph. Calculate according to the succinic acid peak, the number of theoretical plates shall not be less than 8000.
take this product and dry it at 105°C for 1 hour, and the weight loss shall not exceed 5.0% (General rule 0831).
lg of this product shall be taken for inspection according to law (General rule 0841), and the remaining residue shall not exceed 0.2%.
The residue left under the item of burning and flooding shall be inspected according to law (General rule 0821) and shall not contain more than 10 parts per million of heavy metals.
take this product l.Og, add calcium hydroxide l.Og, mix, add water and stir evenly, after drying, first burn with small fire to charring, then burn at 500~600°C to completely Ash, cool, add hydrochloric acid 5ml and water 23ml, inspection according to law (General Principles 0822 first law), shall comply with the provisions (0.0002%).
acetyl and succinyl groups were measured by high performance liquid chromatography (General 0512).
Chromatographic conditions and system adaptability test with acetic acid, succinic acid under
pharmaceutical excipients, coating materials.
sealed storage.