Meleumycin - Names and Identifiers
Meleumycin - Physico-chemical Properties
Meleumycin - Standard
Authoritative Data Verified Data
This product is a multi-component mixture mainly containing midecamycin eight and kitasamycin. According to the dry product calculation, the titer of each lmg should not be less than 850 of the unit.
Last Update:2024-01-02 23:10:35
Meleumycin - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder; Micro-odor.
- This product is easily soluble in methanol, soluble in ethanol, acetone or ethyl acetate, very slightly soluble in water, insoluble in petroleum ether.
Last Update:2022-01-01 11:55:04
Meleumycin - Differential diagnosis
Authoritative Data Verified Data
- in the chromatograms recorded under component checks for midecamycin A1, A2 and kitasamycin A4, A6, A8, the test solution should have five chromatographic peaks that are consistent with the peak retention time of the maleomycin standard solution.
- take this product, add anhydrous ethanol to dissolve and dilute to make a solution containing about 16ug per lml, and measure by UV-Vis spectrophotometry (General 0401), there is an absorption maximum at a wavelength of 232nm.
Last Update:2022-01-01 11:55:04
Meleumycin - Exam
Authoritative Data Verified Data
Related substances
It is determined according to the method under components item of midecamycin A1, A2 and kitasamycin A4, A6, A8, and related substances other than components of A series are calculated according to Peak area of midecamycin A1 by external standard method, the total amount shall not exceed 25%, and the peaks in the chromatogram of the test solution which are smaller than 0.05% of the peak area of midecamycin in the standard solution are negligible.
loss on drying
take an appropriate amount of this product, dry to constant weight at 105°C, and lose no more than 2.0% of weight (General rule 0831).
ignition residue
not more than 0.5% (General rule 0841). Midecamycin A1, A2 and kitasamycin A1, A4, A8 fractions were determined by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane was used as filler, and 0.2mol/L ammonium formate solution (adjusted to pH 7.6 with triethylamine)-acetonitrile (62:38) was used as mobile phase, the column temperature was 30°C, the detection wavelength was 232mn, and the flow rate was 1.5ml per minute. 10ul of maleomycin standard solution was injected into the liquid chromatograph, and the chromatogram recorded should be consistent with the standard chromatogram. The peak order of each component A is A8, A6, A1, A4, and A2.
assay
take the right amount of this product, precision weighing, and mobile phase dissolution and quantitative dilution to make a solution containing about 2mg per 1 ml, as a test solution; take 1u1 injection liquid chromatograph with precision, record chromatogram. Another standard sample of maleomycin was determined by the same method. According to the external standard method to midecamycin peak area calculation, according to the dry product, midecamycin bird should not be less than 48%, kitasamycin K should not be less than 12
Last Update:2022-01-01 11:55:05
Meleumycin - Content determination
Authoritative Data Verified Data
precision weigh the appropriate amount of this product, add ethanol (each 4mg plus ethanol lml) after dissolving, with sterilized water quantitatively made in each lml containing about 1000 units of solution, according to the microbiological assay of antibiotics (General 1201). 1000 unit is equivalent to 1 mg of the white and white tetracycline.
Last Update:2022-01-01 11:55:06
Meleumycin - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:55:06
Meleumycin - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update:2022-01-01 11:55:06
Meleumycin - Meleomycin tablets
Authoritative Data Verified Data
This product contains maleomycin should be labeled amount of 90.0% ~ 110.0%.
trait
This product is sugar-coated tablet or film-coated tablet, after removing the coating, white or white.
identification
take this product, remove the coating, ground fine, add ethanol to dissolve maleomycin, filter, take the filtrate according to the identification test under the item of maleomycin, show the same results.
examination
- the related substances are determined according to the methods of midecamycin Au A2 and kitasamycin A4, A6, A8 components, and the related substances other than A series components are calculated according to the peak area of midecamycin A1 by external standard method, the total amount shall not exceed 30% of the labeled amount, the chromatogram of the test solution is smaller than that of midecamycin A in the standard solution, and the peak with 0.05% of the main peak area is negligible.
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (dilute hydrochloric acid 24ml and water to 1000ml)900ml as the dissolution medium, the rotation speed is 100 rpm, and the operation is carried out according to law. After 30 minutes, the appropriate amount of the solution is taken, filtered, and the appropriate amount of the filtrate is taken, quantitative dilution with dissolution medium to prepare a solution containing about 16ug of malitamycin per lml, and the absorbance was measured at the wavelength of 232nm according to UV-visible spectrophotometry (General rule 0401 ), fine, precision weighing appropriate amount (about equivalent to the average tablet weight), according to the label amount with dissolution medium dissolution and quantitative dilution to make about 16ug per lml of the solution, filtration, take the filtrate, the dissolution amount of each tablet was calculated by the same method. The limit is 80% and shall be in accordance with the provisions.
- midecamycin A1, A3 and kitasamycin A4, A6, A8 10 tablets of this product, precision weighing, fine grinding, precision weighing to take appropriate amount (about equivalent to 20mg of melittin), put it in a 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, filter, take the continued filtrate as the test solution, and measure it according to the method under the item of maleomycin. According to the labeled amount, midecamycin should not be less than 35%, kitasamycin 6 6 should not be less than 13%, A1, A2, A4, A6 and A8 Plus should not be less than 60%.
- 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 take an appropriate amount (about equivalent to malitamycin 0.lg), with 25ml ethanol (such as sugar-coated tablets, Take 5 tablets, fine grinding, with 1000 mL of ethanol), fractionated grinding to dissolve maleomycin, and then quantitative diluted with sterile water to prepare a solution containing about units per 1 ml, and measured according to the method under the item of maleomycin. 1000 unit is equivalent to 1 mg of the white and white tetracycline.
category
The same as maleomycin.
specification
- 0.05g (50,000 units)
- 0.lg (100,000 units)
storage
sealed, stored in a dry place,
Last Update:2022-01-01 11:55:08
Meleumycin - Maibaimycin capsules
Authoritative Data Verified Data
This product contains maleomycin should be labeled amount of 90.0% ~ 110.0%.
trait
The content of this product is white or white powder.
identification
take an appropriate amount of the contents of this product, add ethanol to dissolve maleomycin, filter, take the filtrate to follow the identification test under the item of maleomycin, and show the same results.
examination
- the related substances were determined according to the method under components of midecamycin A1, A2 and kitasamycin A4A6, A8, the total amount of related substances other than components of Series A shall not exceed 30% of the labeled amount calculated by the peak area of midecamycin by the external standard method, peaks in the chromatogram of the test solution which are smaller than 0.05% of the peak area of the midecamycin gas of the standard solution are ignored.
- weight loss on drying this product shall be dried at 105°C to constant weight, and the weight loss shall not exceed 5.0% (General rule 0831).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid-pepsin solution (dilute hydrochloric acid 24ml add water to 1000ml, add 1% pepsin) 900ml as solvent, rotating at 100 rpm, and operate according to law. After 45 minutes, take appropriate amount of solution, filter, and take appropriate amount of filtrate with precision, A solution containing about 16ug of malitamycin per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at the wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (general rule); take the contents under the item of different loading amount, mix evenly, weigh an appropriate amount (equivalent to the average loading amount) precisely, add dissolution medium to dissolve and quantitatively dilute to make a solution containing about 16ug of melittin per lml, filtration, take the filtrate, the same method to determine, calculate the dissolution of each grain, the limit is 80%, should comply with the provisions.
- midecamycin A1, A3 and kitasamycin A4, A6, A8, take the appropriate amount of the content of this product (about 20mg equivalent to maleomycin), Precision weighing, put in 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate as a test solution, according to the method under the item of maleomycin determination. According to the labeled amount, the sum of the components of the A1, A2, A4, A6 and A8 series shall not be less than 35%, 13% and 60% respectively.
- 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, accurately weigh an appropriate amount (about 0.1g equivalent to malitamycin), use 25ml of ethanol, and grind them in portions to dissolve melittin, then the solution containing about 1000 units per 1 ml was prepared by quantitative dilution with sterile water, and was determined according to the method under the item of maleomycin. 1000 unit is equivalent to 1 mg of the white and white tetracycline.
category
The same as maleomycin.
specification
- 0.05g (50,000 units)
- 0.lg (100,000 units)
- 0.2g (200,000 units)
storage
sealed and stored in a dry place.
Last Update:2022-01-01 11:55:09