Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Names and Identifiers
Name | Erythromycin lactobionate
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Synonyms | Erythrocin lactobionate Erythromycin lactobionate Erythrocin Lactobionate IV Erythromycin. compd. with lactobionic acid ERYTHROMYCIN LACTOBIONATE USP(CRM STANDARD) Erythromycin, compd. with lactobionic acid (7CI) Erythromycin, Lactobionate Salt-N,N-dimethyl-13C2 Erythromycin, 4-O-β-D-galactopyranosyl-D-gluconate (salt) Erythromycin, 4-O-beta-D-galactopyranosyl-D-gluconate (salt) Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) 4-O-beta-D-Galactopyranosyl-D-gluconic acid compd. with erythromycin
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CAS | 3847-29-8
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EINECS | 223-348-7 |
InChI | InChI=1/C37H67NO13.C12H22O12/c1-14-25-37(10,45)30(41)20(4)27(39)18(2)16-35(8,44)32(51-34-28(40)24(38(11)12)15-19(3)47-34)21(5)29(22(6)33(43)49-25)50-26-17-36(9,46-13)31(42)23(7)48-26;13-1-3(15)10(7(18)8(19)11(21)22)24-12-9(20)6(17)5(16)4(2-14)23-12/h18-26,28-32,34,40-42,44-45H,14-17H2,1-13H3;3-10,12-20H,1-2H2,(H,21,22)/t18-,19-,20+,21+,22-,23+,24+,25-,26+,28-,29+,30-,31+,32-,34+,35-,36-,37-;3-,4-,5+,6+,7-,8-,9-,10-,12+/m11/s1 |
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Physico-chemical Properties
Molecular Formula | C37H67NO13.C12H22O12
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Molar Mass | 1092.22 |
Density | 0.9083 (rough estimate) |
Melting Point | 145-150° |
Boling Point | 818.4°C at 760 mmHg |
Flash Point | 448.8°C |
Water Solubility | >20g/L(21 ºC) |
Solubility | Soluble in water, freely soluble in anhydrous ethanol and in methanol, very slightly soluble in acetone and in methylene chloride. |
Vapor Presure | 4.94E-31mmHg at 25°C |
Appearance | Solid |
Color | White to Off-White |
Storage Condition | Refrigerator |
Refractive Index | 1.5300 (estimate) |
Use | For the treatment of sinusitis, otitis media, sepsis, scarlet fever and other inflammation caused by Pneumonia Diplococcus |
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Risk and Safety
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Upstream Downstream Industry
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Standard
Authoritative Data Verified Data
This product is the lactouronate of erythromycin. The titer per 1 mg, calculated as anhydrous, shall not be less than 610 erythromycin units.
Last Update:2024-01-02 23:10:35
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Trait
Authoritative Data Verified Data
- This product is white or off-white crystal or powder; Odorless.
- This product is soluble in water or ethanol, slightly soluble in acetone, insoluble in ether.
Last Update:2022-01-01 13:37:06
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the erythromycin A component, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the standard solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 257). If it is found that the absorption peak at l680cm-1 ~ 1750 is not consistent with the spectrum of the control, it is advisable to take an appropriate amount of this product, dissolve it in anhydrous ethanol, evaporate it on a water bath, and dry it under reduced pressure in a reduced pressure dryer for determination.
Last Update:2022-01-01 13:37:07
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Exam
Authoritative Data Verified Data
pH
take 0.85g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 6.0~7.5.
clarity and color of solution
take 5 parts of this product, each 0.85g, respectively, and add 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow No. 1 Standard Colorimetric solution (General Principles 0901 first method).
erythromycin B, C components and related substances
take this product, add an appropriate amount of methanol (lOmg plus methanol lml) dissolved, with phosphate buffer (pH 7.0)-methanol (15:1) quantitative dilution is made into a solution containing about 4mg of erythromycin per 1 ml, as the test solution; 5ml of the test solution is precisely weighed, and the solution is placed in a 100ml measuring flask, and phosphate buffer solution (pH 7.0) is used.-Methanol (15:1) was diluted to the scale and shaken as a control solution. According to the chromatographic conditions under the erythromycin A component item, 20 u1 of the test solution and the control solution were accurately taken, respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 5 times of the retention time of the main peak. Erythromycin B calculated as corrected peak area (multiplied by correction factor 0.7) and erythromycin C peak area shall not be greater than the main peak area of the control solution (5.0%). If there are impurity peaks in the chromatogram of the test solution, except lactobionic acid (about 2 minutes), erythromycin enol ether and impurity I are calculated according to the corrected peak areas (multiplied by the correction factors 0.09 and 0.15 respectively) and other single impurity peak area shall not be greater than 0.6 times (3.0%) of the main peak area of the control solution; The sum of other impurity peak areas shall not be greater than the main peak area of the control solution (5.0%) (The test solution should be freshly prepared before use). The peaks in the chromatogram of the test solution which were 0.01 times smaller than the main peak area of the control solution were ignored.
moisture
take about 0.2g of this product, add 10% imidazole anhydrous methanol solution to dissolve, according to the determination of water content (General 0832 first method 1), the water content shall not exceed 4.0%.
erythromycin A component
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate solution (take dipotassium hydrogen phosphate 8.7g, add water 1000ml, adjust the pH value to 20% with 8.2 phosphoric acid)-Acetonitrile (40:60) as mobile phase; Column temperature was 35°C; Wavelength was 215nm. An appropriate amount of erythromycin standard was taken and heated at 130 ° C. For 4 hours. After dissolving the appropriate amount of methanol (erythromycin 10 mg plus methanol 1 ml), phosphate buffer (pH 7.0)-methanol (15:1) was used. A solution containing about 4mg per 1 ml was prepared by dilution, and 20 U1 was flowed into the liquid chromatograph. The chromatogram was recorded to 5 times the retention time of erythromycin A. Peaks were generated in the order of erythromycin C, erythromycin A, impurity I, erythromycin B, and erythromycin enol ether peaks (peak positioning was performed with erythromycin C, erythromycin B, and erythromycin enol ether controls, if necessary). The resolution of erythromycin A peak and erythromycin enol ether peak should be greater than 14.0, and the tailing factor of erythromycin A peak should be less than 2.0.
- determination of this product is about 0.17g and erythromycin standard about 0.lg, precision weighing, respectively, plus an appropriate amount of methanol (10 mg plus methanol lml) dissolved, with phosphate buffer salt (pH 7.0)-Quantitative dilution of Methanol (15:1) to prepare a solution containing about 4mg of erythromycin per 1 ml as a test solution and a standard solution, respectively; the sample solution and the standard solution of 20 u1 were respectively injected into the human liquid chromatograph, the chromatogram was recorded, and the content of erythromycin A in the sample was calculated by the peak area according to the external standard method. Not less than 59.1%, calculated as anhydrous.
visible foreign body
take 5 parts of this product, each part is the maximum specification of the preparation, respectively, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, respectively, plus particles dissolved in water, according to the law (General 0903), each lg of sample, containing 10um and 10um particles shall not exceed 6000, no more than 600 particles containing 25um and more than 25um. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General 1143), each 1 mg of erythromycin containing endotoxin should be less than 1.0EU. (For injection)
sterile
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update:2022-01-01 13:37:08
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Content determination
Authoritative Data Verified Data
take an appropriate amount of this product, precision weighing, and add sterilized water to make a solution containing about 1000 units per 1 ml, according to the method under erythromycin microbiological assay for antibiotics (General 1201 first method). 1000 erythromycin units are equivalent to 1 mg of c37h67no13. Confidence limits should not be greater than 7%.
Last Update:2022-01-01 13:37:09
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Category
Authoritative Data Verified Data
Last Update:2022-01-01 13:37:09
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update:2022-01-01 13:37:09
Erythromycin mono(4-O-beta-D-galactopyranosyl-D-gluconate) (salt) - Erythromycin lactobionate for injection
Authoritative Data Verified Data
This product is sterile Crystal, powder or sterile lyophilized product of erythromycin lactobionate. The titer of erythromycin per lmg shall not be less than 610 units calculated as anhydrous substance; The content of erythromycin (C37H67NO13) shall be 93.0% ~ 107.0% of the labeled amount calculated as the average loading child.
trait
This product is white or off-white crystalline or powder or loose lumps.
identification
take this product, according to erythromycin lactobionate under the identification test, showed the same results.
examination
- the clarity and color of the solution: take 5 bottles of this product and add water to prepare a solution containing about 50mg of erythromycin per 1 ml according to the label. The solution should be clear and colorless; If it is turbid, compared with No. 1 turbidity standard liquid (General rule 0902 first method), shall not be more concentrated; If color, compared with the yellow No. 1 Standard Colorimetric liquid (General rule 0901 first method), shall not be deeper.
- water content: take about 0.2g of this product, add 10% imidazole anhydrous methanol solution to dissolve it, and determine the water content according to the method of moisture determination (General rule 0832, first method 1). The water content shall not exceed 5.0%.
- the pH value, erythromycin B, C components and related substances, erythromycin A components, bacterial endotoxin and sterility shall be checked according to the method of erythromycin lactobionate, and shall meet the requirements.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The content under the item of loading amount difference was accurately weighed and an appropriate amount was measured according to the method of erythromycin lactobionate.
category
Same as erythromycin lactobionate.
specification
as erythromycin (1)0.25g (250,000 units) (2)0.3g (300,000 units)
storage
sealed and stored in a dry place.
Last Update:2022-01-01 13:37:10