Name: erythromycin estolate
CAS: 3521-62-8
Molecular Formula: C52H97NO18S
Molecular Weight: 1056.39
erythromycin estolate - Names and Identifiers
| Name | erythromycin estolate |
| Synonyms | Erythromycin estolate [USAN:BAN:JAN] Biomicron Eriscel Eritroger Eromycin Ery-Toxinal dodecylsulfate Erythromycin 2'-propionate dodecyl sulfate (salt) Erythromycin 5-(3-propionate) dodecyl sulfate Erythromycin propionate dodecylsulfate (salt) Erythromycin propionate lauryl sulfate Erythromycin propionate, compd. with dodecyl sulfate Erythromycin propionate, compound with dodecyl sulfate Erythromycin propionyl laurylsulfate Erythromycin, propionate (ester), compd. with monododecyl sulfate Erythromycine estolate Erytrarco Estomicina Ilosone Lauromicina Lauryl sulfate propionyl erythromycin ester Lubomycine B Marcoeritrex NSC 263364 Neo-erycinum PELS Propionic acid, 2'-ester with erythromycin, dodecyl sulfate salt Propionylerythromycin lauryl sulfate Prospiocine Roxomicina Stellamicina Sulfuric acid, monododecyl ester, compd. with erythromycin 2'-propionate (1:1) UNII-XRJ2P631HP Erythromycin, 2'-propanoate, dodecyl sulfate (salt) Erythromycin, 2'-propionate, monododecyl sulfate (salt) (8CI) Erythromycin, propionate (ester), compd. with monododecyl sulfate (1:1) Sulfuric acid, monododecyl ester, compd. with erythromycin 2'-propanoate (1:1) 4-(dimethylamino)-2-({(3R,4S,6R,7R,9R,11R,12R,13S,14R)-14-ethyl-7,12,13-trihydroxy-4-[(5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy]-3,5,7,9,11,13-hexamethyl-2,10-dioxooxacyclotetradecan-6-yl}oxy)-6-methyltetrahydro-2H-pyran-3-yl propanoate - dodecyl hydrogen sulfate (1:1) (non-preferred name) 4-(dimethylamino)-2-({14-ethyl-7,12,13-trihydroxy-4-[(5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy]-3,5,7,9,11,13-hexamethyl-2,10-dioxooxacyclotetradecan-6-yl}oxy)-6-methyltetrahydro-2H-pyran-3-yl propanoate - dodecyl hydrogen sulfate (1:1) (non-preferred name) 2-({(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-ethyl-7,12,13-trihydroxy-4-[(5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy]-3,5,7,9,11,13-hexamethyl-2,10-dioxooxacyclotetradecan-6-yl}oxy)-N,N,6-trimethyl-3-(propanoyloxy)tetrahydro-2H-pyran-4-aminium dodecyl sulfate (non-preferred name) Erythromycin 2'-Propionate Dodecyl Sulfate |
| CAS | 3521-62-8 |
| EINECS | 222-532-4 |
| InChI | InChI=1/C40H71NO14.C12H26O4S/c1-15-27-40(11,48)33(44)22(5)30(43)20(3)18-38(9,47)35(55-37-32(53-28(42)16-2)26(41(12)13)17-21(4)50-37)23(6)31(24(7)36(46)52-27)54-29-19-39(10,49-14)34(45)25(8)51-29;1-2-3-4-5-6-7-8-9-10-11-12-16-17(13,14)15/h20-27,29,31-35,37,44-45,47-48H,15-19H2,1-14H3;2-12H2,1H3,(H,13,14,15)/t20-,21?,22+,23+,24-,25?,26?,27-,29?,31+,32?,33-,34?,35-,37?,38-,39?,40-;/m1./s1 |
erythromycin estolate - Physico-chemical Properties
| Molecular Formula | C52H97NO18S |
| Molar Mass | 1056.39 |
| Boling Point | 827.7°C at 760 mmHg |
| Flash Point | 454.4°C |
| Vapor Presure | 8.87E-32mmHg at 25°C |
| Use | For penicillin-resistant Staphylococcus aureus infections and penicillin-allergic Staphylococcus aureus infections |
erythromycin estolate - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed R42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S22 - Do not breathe dust. S36 - Wear suitable protective clothing. |
erythromycin estolate - Upstream Downstream Industry
erythromycin estolate - Standard
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.
Last Update：2022-01-01 13:36:02
erythromycin estolate - Trait
- This product is white crystalline powder; Odorless.
- This product is soluble in ethanol or three gas methane, almost insoluble in water.
melting point
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.
Last Update：2022-01-01 13:36:03
erythromycin estolate - Differential diagnosis
- take about 5mg of this product, add 2ml of acetone to dissolve, add 2ml of hydrochloric acid, that is orange yellow, gradual to purple red, then add 2ml of chloroform shaking, chloroform layer blue.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 36).
Last Update：2022-01-01 13:36:03
erythromycin estolate - Exam
pH
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.
free erythromycin
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%.
residual solvent
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.
moisture
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%.
Last Update：2022-01-01 13:36:04
erythromycin estolate - Content determination
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.
Last Update：2022-01-01 13:36:05
erythromycin estolate - Category
macrolide antibiotics.
Last Update：2022-01-01 13:36:05
erythromycin estolate - Storage
light shielding, sealed storage.
Last Update：2022-01-01 13:36:05
erythromycin estolate - Relying on erythromycin tablets
This product contains erythromycin based on erythromycin (C37H67NO13), should be 90.0% to 110.0% of the label.
trait
This product is white tablet.
identification
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.
examination
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.2% of sodium dodecyl sulfate in hydrochloric acid solution (9-1000) as the dissolution medium (50mg,62.5mg specification, dissolution medium 600ml), rotational speed of 75 rpm, operated according to law, after 45 minutes, take appropriate amount of solution, filter, weigh density, take appropriate amount of filtrate, quantitative dilution with dissolution medium to prepare a solution containing about 83ug of erythromycin per 1 ml, as a test solution> another 10 tablets of this product, precision weighing, grinding, precision weighing appropriate amount (about equivalent to the average tablet weight), and adding the appropriate amount of ethyl alcohol (according to the label amount of erythromycin and ethyl alcohol 5ml per 25mg) after dissolving, A solution containing about 83% of erythromycin per 1 ml was prepared by quantitative dilution with dissolution medium according to the labeled amount, filtered, and the filtrate was taken as a control solution. Take 5ml of test solution and 5ml of control solution respectively, add 5ml of human sulfuric acid solution (75-100), shake, place for 30 minutes, cool, the absorbance was measured at a wavelength of 482mn by ultraviolet-visible spectrophotometry (General rule 0401), and the elution amount of each tablet was calculated. The limit is 70% and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
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.
category
Same as erythromycin.
specification
by (l) 50mg (50,000 units)(2)62.5mg (62,500 units)(3)0.125g (125,000 units)
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:36:06
erythromycin estolate - Relying on erythromycin capsules
This product contains erythromycin based on erythromycin (C37H67NO13), should be 90.0% to 110.0% of the label.
identification
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.
examination
- water content of this product is about 0.2g, and 10% imidazole anhydrous methanol solution is added to dissolve the solution. According to the determination method of water content (General rule 0832, first method 1), the water content shall not exceed 5.0%.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.2% of 12 alkyl sulfate acid & hydrochloric acid solution (9-1000)900ml dissolution medium (50mg specification, dissolution medium 600ml) speed is 75 rpm, according to the law, 45 minutes, take the appropriate amount of solution, filtration, precision take the appropriate amount of filtrate, quantitative dilution with dissolution medium to prepare a solution containing about 83ug of erythromycin per 1 ml as a test solution; Separately take the content I under the item of difference in loading amount, mix evenly and grind finely, accurately weigh appropriate amount (about equivalent to the average loading), add appropriate amount of ethanol (according to the labeled amount of erythromycin per 25mg plus ethanol 5ml) after dissolving, A solution containing about 83ug of erythromycin per 1 ml was prepared by quantitative dilution with dissolution medium as indicated, filtered, and the filtrate was taken as a control solution. 5ml of the test solution and 5ml of the control solution were accurately added with 5ml of human sulfuric acid solution (75-100) respectively, shaken, placed for 30 minutes, cooled, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (general rule), and the elution amount of each particle was calculated. The limit is 70% and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
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.
category
Same as erythromycin.
specification
Based on C37H67NO13 (1) 50mg (50,000 units)(2)0.125g (125,000 units) (3)0.25g (250,000 units)
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:36:07
erythromycin estolate - Erythromycin granules
This product contains erythromycin based on erythromycin k erythromycin (C37H67NO13) calculation, should be 90.0% ~ 110.0% of the labeled amount.
trait
This product is suspended particles; Gas fragrance.
identification
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.
examination
- pH value: take 3.3g of this product, Add 10ml of water to make a uniform suspension, and determine it according to law (General rule 0631). The pH value should be 5.0~7.0.
- the water content of this product is about 0.2g, and 10% imidazole anhydrous methanol solution is added to dissolve it. The water content shall not exceed 0832 as determined by the method of moisture determination (General rule 2.0%, first method 1).
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
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.
category
Same as erythromycin.
specification
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)
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:36:08
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CAS ： 3521-62-8
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Raw Materials for erythromycin estolate
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