Molecular Formula | C52H97NO18S |
Molar Mass | 1056.39 |
Density | 1.0053 (rough estimate) |
Melting Point | 135-140°C dec. |
Boling Point | 743℃ |
Flash Point | >110°(230°F) |
Water Solubility | Freely soluble in organic solvents, practically insoluble in water/n |
Solubility | chloroform: soluble4.0ML, clear, colorless (200 mg + 4.0 mL Chloroform) |
Vapor Presure | 8.87E-32mmHg at 25°C |
Appearance | neat |
Color | white |
pKa | 6.9(at 25℃) |
Storage Condition | Keep in dark place,Sealed in dry,Room Temperature |
Sensitive | Light Sensitive |
Refractive Index | 1.6550 (estimate) |
Physical and Chemical Properties | Relying on the existing production process of erythromycin with erythromycin thiocyanate as the main raw material, with acetone as the solvent, potassium carbonate desulfurization layered filtration plus potassium carbonate adsorption dehydration filtration, after forming an ester with propionic anhydride, a dodecylsulfate solution is added to synthesize erythromycin. Relying on erythromycin tablets are generally ordinary tablets, if its friability is not well controlled, it is easy to break, crack and crush, which will affect the quality of tablets. The dissolution rate of erythromycin-based tablets depends on the degree of seed strength of erythromycin-based tablets. If the degree of seed strength of erythromycin-based tablets is not well controlled, it will also affect the uniformity and stability of tablet quality, thus affecting the stability of drug efficacy. |
Use | For penicillin-resistant Staphylococcus aureus infections and penicillin-allergic Staphylococcus aureus infections |
Risk Codes | R22 - Harmful if swallowed R42/43 - May cause sensitization by inhalation and skin contact. R36/37/38 - Irritating to eyes, respiratory system and skin. |
Safety Description | S22 - Do not breathe dust. S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
WGK Germany | 3 |
RTECS | KF5775000 |
HS Code | 29419000 |
Toxicity | LD50 orally in rats: >5000 mg/kg (Goldenthal) |
This product is the dodecylsulfate salt of erythromycin propionate. The titer per 1 mg, calculated as anhydrous, shall not be less than 610 erythromycin units.
take this product, dry it in a phosphorus pentoxide dryer, and then measure it according to law (General rule 0612). The melting point is 132~138°C, and the melting point is decomposed at the same time.
take 0.4g of this product, add water 10ml, fully stirred, take the supernatant, according to the law (General 0631),pH value should be 5.0~7.2.
new system for clinical use. Take an appropriate amount of this product, dissolve and quantitatively dilute with acetonitrile to prepare a solution containing 5mg per 1 ml as a test solution. Another erythromycin standard was taken, dissolved with acetonitrile and quantitatively diluted to prepare A solution containing 0.15mg of erythromycin A per 1 ml as A control solution. Determined by high performance liquid chromatography (General 0512). With eighteen alkyl silane bonded silica gel as filler; With potassium dihydrogen phosphate solution (weigh potassium dihydrogen phosphate 3.4g, add triethylamine 2.75ml, then add water to dissolve and dilute to 1000ml)-acetonitrile (65:35), the pH value was adjusted to 3.0 with dilute hydrochloric acid as the mobile phase; The column temperature was 30 ° C.; The detection wavelength was 195nm. Take the appropriate amount of this product and erythromycin standard, add mobile phase to dissolve and dilute to make a solution containing about 0.5mg per 1 ml, take 20ul injection human liquid chromatograph, record the chromatogram, the resolution between erythromycin A peak and erythromycin relying peak should be greater than 5.0. 20 u1 of the test solution and the reference solution were respectively injected into the human liquid chromatograph. The chromatogram was recorded and the peak area was calculated according to the external standard method. Free erythromycin was not more than 3.0%.
take about 0.05g of this product, precision weighing, put it in the top empty bottle, Precision Add 5ml of water, shake, seal, as a test solution; Precision weighing the right amount of acetone, A solution containing about 0.05mg per 1 ml was prepared by quantitative dilution with water, and 5ml was accurately weighed into the headspace bottle and sealed as a reference solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 6% cyanopropylphenyl-94% dimethyl polysiloxane (or similar polarity) as the stationary liquid is the column; The column temperature is 50°C; the temperature of the detector is 250°C; The temperature of the injection port is 140°C; The equilibrium temperature of the headspace bottle is 90°C, and the equilibrium time is 30 minutes, the sample solution and the reference solution were sampled by Headspace injection respectively. The chromatogram was recorded and the peak area was calculated according to the external standard method. The residual amount of acetone should be in accordance with the regulations.
take this product, add 10% imidazole anhydrous methyl alcohol solution to dissolve, according to the moisture determination method (General 0832 first method 1) determination, containing water not more than 4.0%.
take an appropriate amount of this product (about 50mg of erythromycin), put it in a 100ml measuring flask, dissolve it with 50ml of ethyl alcohol, and then dilute it to the scale with phosphate buffer (pH 7.8), shake well, place in a water bath at 60°C for 4 hours to complete the hydrolysis. Take about 25mg of erythromycin standard sample and place it in a 50ml measuring flask, then dilute to the scale with phosphate buffer solution (pH 7.8), shake well, and measure according to the method under erythromycin for microbiological assay of antibiotics (General rule 1201). 1000 erythromycin units are equivalent to 1 mg of C37H47NO13.
macrolide antibiotics.
light shielding, sealed storage.
This product contains erythromycin based on erythromycin (C37H67NO13), should be 90.0% to 110.0% of the label.
This product is white tablet.
take 1 tablet of this product, grind, add three gas methane 5ml, grind, filter, take the filtrate to distill off the three gas methane, and the residue is identified according to the identification (1) Test under the item of relying on erythromycin, the same results are shown.
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to erythromycin 0.125g), put it in a 250ml measuring flask, add 125ml ethanol to dissolve, then dilute to the scale with phosphate buffer (pH 7.8), shake well, and place in a water bath at 60°C for 4 hours to complete the hydrolysis. Precise quantity the appropriate amount of the solution was taken and determined according to the method under the item of relying on erythromycin.
Same as erythromycin.
by (l) 50mg (50,000 units)(2)62.5mg (62,500 units)(3)0.125g (125,000 units)
light shielding, sealed storage.
This product contains erythromycin based on erythromycin (C37H67NO13), should be 90.0% to 110.0% of the label.
take an appropriate amount of the content of this product (about 50mg of erythromycin), grind, add 5ml of chloroform, grind, filter, take the filtrate to distill chloroform, the residue showed the same result according to the identification (1) Test under the item of erythromycin.
take the contents under the difference of loading amount, mix evenly, grind finely, weigh an appropriate amount accurately (about 0.125g equivalent to erythromycin), put it in a 250ml measuring flask, add ml of ethanol to dissolve, then dilute to the scale with phosphate buffer (pH 7.8), shake well, and place in a water bath at 60°C for 4 hours to complete the hydrolysis. Precision take appropriate amount of supernatant, according to the method under the item of relying on erythromycin determination, that is obtained.
Same as erythromycin.
Based on C37H67NO13 (1) 50mg (50,000 units)(2)0.125g (125,000 units) (3)0.25g (250,000 units)
light shielding, sealed storage.
This product contains erythromycin based on erythromycin k erythromycin (C37H67NO13) calculation, should be 90.0% ~ 110.0% of the labeled amount.
This product is suspended particles; Gas fragrance.
take the fine powder of this product (about 20mg of erythromycin), put it in a centrifuge tube, add an appropriate amount of water, make it into a uniform suspension, centrifuge, and discard the upper liquid, the above operation was repeated 3 times. After the precipitate was dried in a phosphorus pentoxide dryer, the same reaction was shown according to the identification (1) Test under erythromycin.
take the contents under the difference of loading amount, mix evenly, grind finely, weigh an appropriate amount accurately (about 0.125g equivalent to erythromycin), put it in a 250ml measuring flask, add ml of ethanol to dissolve, then dilute to the scale with phosphate buffer (pH 7.8), shake well, and place in a water bath at 60°C for 4 hours to complete the hydrolysis. Precision take appropriate amount of supernatant, according to the method under the item of relying on erythromycin determination, that is obtained.
Same as erythromycin.
calculated as C37H67NO13 (l) 50mg (50,000 units)(2)75mg (75,000 units) (3) 100,000 mg (125,000 units) (4) mg (units) (5)250mg (250,000 units)
light shielding, sealed storage.