Name | Bleomycin A5 Hydrochloride |
Synonyms | BLEOCIN(TM) Bleomycin A5 Hydrochlorid Bleomycin A5 Hydrochloride Bleomycin A5 Hydrochloride Salt BleoMycin A5 Hydrochloride(PingyangMycin hydrochloride) N1-[3-[(4-Aminobutyl)amino]propyl]bleomycinamide hydrochloride n(sup1)-(3-((4-aminobutyl)amino)propyl)-bleomycinamidhydrochloride n(sup1)-(3-((4-aminobutyl)amino)propyl)bleomycinamidehydrochloride |
CAS | 55658-47-4 |
InChI | InChI=1/C57H89N19O21S2.ClH/c1-22-35(73-48(76-46(22)61)27(14-33(60)80)68-15-26(59)47(62)86)52(90)75-37(43(28-16-65-21-69-28)95-56-45(41(84)39(82)31(17-77)94-56)96-55-42(85)44(97-57(63)92)40(83)32(18-78)93-55)53(91)70-24(3)38(81)23(2)49(87)74-36(25(4)79)51(89)67-13-8-34-71-30(20-98-34)54-72-29(19-99-54)50(88)66-12-7-11-64-10-6-5-9-58;/h16,19-21,23-27,31-32,36-45,55-56,64,68,77-79,81-85H,5-15,17-18,58-59H2,1-4H3,(H2,60,80)(H2,62,86)(H2,63,92)(H,65,69)(H,66,88)(H,67,89)(H,70,91)(H,74,87)(H,75,90)(H2,61,73,76);1H/t23-,24-,25-,26+,27+,31+,32-,36+,37+,38+,39-,40-,41+,42+,43+,44+,45+,55-,56+;/m1./s1 |
Molecular Formula | C57H89N19O21S2.ClH |
Molar Mass | 1477.04 |
Melting Point | >185°C (dec.) |
Solubility | DMSO (Slightly), Methanol (Slightly), Water (Slightly) |
Appearance | Solid |
Color | White to Pale Yellow |
Storage Condition | Keep in dark place,Inert atmosphere,Store in freezer, under -20°C |
Stability | Hygroscopic |
This product is aromatic butyl) chloro] propyl] bleomycin amine hydrochloride. The content of pingyangmycin hydrochloride (C57H89N19021S2 • nHCl) shall not be less than 85.0% calculated on a dry basis.
take this product, add water to make a solution containing about 4mg per 1 ml, according to the law (General 0631) ,pH value should be 45.~6.0.
take 5 parts of this product, 10mg each, respectively, add 2ml 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, it shall not be deeper in comparison with the yellow or yellow-green standard colorimetric solution No. 2 (General Principles 0901, Method 1).
take an appropriate amount of this product, add water to dissolve and dilute to make 2.0 mg of the solution was used as a test solution; 2ml was accurately weighed, placed in a 100ml measuring flask, diluted with water to a scale, and shaken to obtain a control solution. According to the chromatographic conditions under the content determination item, 20ul of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there are impurity peaks in the chromatogram of the test solution, the maximum impurity peak area shall not be greater than 3.5 times (7.0%) of the main peak area of the corrected control solution, other single impurity peak area shall not be greater than 2.5 times (5.0%) of the main peak area of the control solution after correction, and the sum of each impurity peak area shall not be greater than 7.5 times (15.0%) of the main peak area of the control solution after correction, the peaks in the chromatogram of the test solution which were 0.025 times smaller than the main peak area of the control solution were ignored. (The main peak area of the control solution divided by the content of the test sample is the corrected Main Peak area of the control solution).
take this product, with phosphorus pentoxide as desiccant, at 60°C under reduced pressure drying to constant weight, weight loss should not exceed 6.0% (General rule 0831).
take about 15mg of this product, weigh it accurately, put it in a 10ml measuring flask, add 0.1 mol/L hydrochloric acid solution (3ml) was used for dissolution. Copper control solution [copper sulfate (CnS04 • 5H20) (1.965g) was accurately weighed and placed in a measuring flask. 1 mol/L hydrochloric acid solution dissolved and diluted to the scale, shake, precision take 5ml, 500ml flask, with 0.lmol/L hydrochloric acid solution diluted to the scale. Add 0.4ml of 3% gum arabic solution to each of the above two measuring bottles, and shake well, add 2ml of Sodium diethyldithiocarbamate solution and use 0.1 mol/L hydrochloric acid solution diluted to the scale, shake, respectively, as the test solution and copper control dilution solution; Another 0. The 1 mol/L hydrochloric acid solution was operated in the same method as a blank; The absorbance was measured at the wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 0.1%), and the copper content was not more.
take this product, plus sodium chloride injection made of 2mg per lml solution, according to the law inspection (General 1141), observation for 7 days, should comply with the provisions. (For injection)
take this product, check according to law (General 1143), per 1 mg pingyangmycin hydrochloride containing endotoxin should be less than 5.0EU. (For injection)
take an appropriate amount of this product, check according to law (General rule 1145)9 dose according to the cat weight per lkg injection of pingyangmycin hydrochloride 0.3mg, should meet the requirements. (For injection)
measured by high performance liquid chromatography (General 0512).
silica gel was bonded with octa-alkyl silane as filler; Sodium hexanesulfonate solution (sodium hexanesulfonate 7.53g, ethylenediamine tetraacetic acid disodium 3.72g, 0.08mol /L acetic acid solution was added to dissolve and dilute to 1000ml, the mobile phase A was adjusted to pH 4.3 with ammonia solution. Methanol-acetonitrile (7:3) was used as the mobile phase B, and the linear gradient elution was carried out according to the following table. The detection wavelength was 254nm. Take two copies of this product, each about 8mg, one plus lmol / L hydrochloric acid solution 1.0, another plus 30% hydrogen peroxide solution l. After 1 hour, mix, add 2ml of water, and shake to obtain about 1 ml of pingyangmycin hydrochloride 2. The mixed solution of Omg and its acid degradation products (about 10%) and oxidation degradation products (about 15%), take 20u1 injection human liquid chromatograph, record chromatogram, acid degradation peak, pingyangmycin peak, oxidative degradation peak (relative retention time is about 0.94,1.0,1.1), the retention time of the pingyangmycin peak was approximately 20 minutes. The resolution between acid degradation peak and pingyangmycin peak should be greater than 1.0, and between pingyangmycin peak and oxidative degradation peak should be greater than 1.5.
take an appropriate amount of this product, accurately weigh it, add water to dissolve it and quantitatively dilute it to make a solution containing about 0.4mg per lml, as a test solution, and take 20ul of the precision quantity to inject human liquid chromatograph, the chromatogram was recorded. The reference substance of pingyangmycin hydrochloride was determined by the same method. According to the external standard method to calculate the peak area, that is.
Anti-tumor antibiotics.
sealed, 2~8°C protected from light.
This product is a sterile freeze-dried product made of pingyangmycin hydrochloride or gelatin. Containing pingyangmycin hydrochloride (C57H89N19021S2 • nHCl) shall be between 90.0% and 110 of the labeled amount.
This product is white loose lumps or powder.
take this product, according to the identification test under the item of pingyangmycin hydrochloride, showed the same results.
Take 10 bottles of this product, add water to dissolve and quantitatively dilute to make a solution containing about 0.4mg per lml (8mg specification and quantitatively dilute to make a solution containing about 0.32mg per lml), the test solution was measured according to the method described for pingyangmycin hydrochloride, and the average content of 10 vials was determined.
with pingyangmycin hydrochloride.
(l)4mg (2)8mg
sealed and stored in a cool dark dry place.