Name | doxorubicin hydrochloride |
Synonyms | ADRIACIN ADRIBLASTINA ADRIAMYCIN HCL Doxorubicin HCL Doxorubicin, HCl ADRIAMYCIN HYDROCHLORIDE 14-HYDROXYDAUNOMYCIN HCL doxorubicin hydrochloride ADRIBLASTINA HYDROCHLORIDE 14-HYDROXYDAUNOMYCIN HYDROCHLORIDE (8s-cis)-10-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione hydrochloride (8s-cis)-10-[(3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxynaphthacene-5,12-dione hydrochloride |
CAS | 25316-40-9 |
EINECS | 246-818-3 |
InChI | InChI=1/C27H29NO11.ClH/c1-10-22(31)13(28)6-17(38-10)39-15-8-27(36,16(30)9-29)7-12-19(15)26(35)21-20(24(12)33)23(32)11-4-3-5-14(37-2)18(11)25(21)34;/h3-5,10,13,15,17,22,29,31,33,35-36H,6-9,28H2,1-2H3;1H/t10-,13-,15-,17-,22+,27-;/m0./s1 |
InChIKey | MWWSFMDVAYGXBV-RUELKSSGSA-N |
Molecular Formula | C27H30ClNO11 |
Molar Mass | 579.98 |
Melting Point | 216°C (dec.)(lit.) |
Boling Point | 810.3°C at 760 mmHg |
Specific Rotation(α) | D20 +248±2° (c = 0.1 in methanol) |
Flash Point | 443.8°C |
Water Solubility | Soluble in water. |
Solubility | Easily soluble in water and methanol, slightly soluble in ethanol, very slightly soluble in chloroform, almost insoluble in acetone. |
Vapor Presure | 9.64E-28mmHg at 25°C |
Appearance | Orange-Red Powder |
Color | orange to dark red |
Maximum wavelength(λmax) | ['497nm(H2O)(lit.)'] |
Merck | 14,3439 |
BRN | 4229251 |
pKa | pKa 8.25±0.60 (Uncertain);8.43±0.70 (Uncertain);11.9±0.4 (Uncertain);12.95±0.1 (Uncertain);13.8±0.70 |
Storage Condition | 2-8°C |
Stability | Stable for 1 year from date of purchase as supplied. Solutions in distilled water may be stored at -20° for up to 3 months. |
MDL | MFCD04974507 |
Physical and Chemical Properties | Hydrochloride is an orange-red needle-like crystal with a melting point of 204-205 °c. Soluble in water and alcohol, insoluble in acetone, benzene, chloroform, ether. |
Risk Codes | R45 - May cause cancer R22 - Harmful if swallowed R40 - Limited evidence of a carcinogenic effect R26/27/28 - Very toxic by inhalation, in contact with skin and if swallowed. R36/38 - Irritating to eyes and skin. |
Safety Description | S53 - Avoid exposure - obtain special instructions before use. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S22 - Do not breathe dust. S7/9 - |
WGK Germany | 3 |
RTECS | QI9295900 |
FLUKA BRAND F CODES | 10-21 |
HS Code | 29419090 |
Toxicity | LD50 i.v. in mice: 21.1 mg/kg (Bertazzoli, 1970) |
This product is (8S,10s)-10-[(3-amino -2,3, 6-tridesoxy-a -L-lysohexopyranyl)-Oxygen]-7,8,9, 10-tetrahydro-6, 8, 11-trihydroxy-8-(hydroxyacetyl) -1-methoxy-5, 12-naphthalene Dione hydrochloride. Doxorubicin hydrochloride (C27H29NO11 • HCl) should be 98.0% to 102.0% based on water and solvent-free material.
take a small amount of this product, according to the law inspection (General 0981), should comply with the provisions.
take this product, add water to make a solution containing 5mg per lml, according to the law (General 0631) , pH value should be 4.0~5.5.
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make about 1 in each lml. 0 mg of the solution was used as a test solution; An appropriate amount of the solution was quantitatively diluted with a mobile phase to prepare a solution containing about 1 ug per 1 ml as a control solution. According to the chromatographic conditions under the content determination item, 10 u1 of the test solution and 10 u1 of the control solution are accurately weighed and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3.5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution.
take about 0.2g of this product, precision weighing, set in the top empty bottle, precision add water 5ml to dissolve, seal, as a test solution; Respectively, precision weighing methanol, ethanol, each appropriate amount of acetone and dichloromethane was quantitatively diluted with dimethyl sulfoxide to prepare their respective stock solutions, and each appropriate amount was quantitatively diluted with water to prepare each lml containing 20ug of methanol and 0.2mg of ethanol, the mixed solution of acetone 10ug and dichloromethane 2ug was precisely weighed into 5ml, placed in a headspace bottle, and sealed as a reference solution. According to the test for determination of residual solvents (General rule 0861 first method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the chromatographic column, and the column temperature is 50°C; the inlet temperature was 140°C; The detector temperature was 250°C; The carrier gas was helium or nitrogen, and the flow rate was 5.0 mL per minute. The Headspace sample was injected, and the equilibrium temperature of the headspace bottle was 90°C, and the equilibrium time was 30 minutes. The reference solution was sampled by Headspace injection, and the chromatogram was recorded. Methanol, ethanol, acetone and dichloromethane peaks in sequence, and the separation degree between the four main peaks should meet the requirements. The test solution and the reference solution were injected into the headspace respectively, and the chromatogram was recorded, and the peak area was calculated according to the external standard method. Ethanol residues should not exceed 1.0%, methanol, acetone and dichloromethane residues should be in accordance with the provisions.
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 4.0%.
take this product, check according to law (General 1143), each 1 mg doxorubicin hydrochloride containing endotoxin amount should be less than 2.0EU. (For injection)
take this product, check according to law (General rule 1145), the dose of cat weight per lkg injection 1.5mg, should meet the requirements. (For injection)
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane as filler; Sodium dodecyl sulfate solution (take sodium dodecyl sulfate 1.44G and phosphoric acid 0.68ml, add water 500ml to dissolve)-acetonitrile-methanol (500:500:60) as the mobile phase; The detection wavelength is 254nm; Take the appropriate amount of doxorubicin hydrochloride reference and epirubicin hydrochloride reference, dissolve and dilute with the mobile phase to make a mixed solution containing 50ug in each lml, take 10u1 injection human liquid chromatograph, record chromatogram, the separation degree between doxorubicin peak and epirubicin peak should be greater than 2.0.
take the appropriate amount of this product, precision weighing, plus mobile phase dissolution and quantitative dilution made from each lml containing about O. 1 mg of the solution, as the test solution, the precise amount of 10u1 was injected into the liquid chromatograph, and the chromatogram was recorded. The control substance of doxorubicin hydrochloride was taken and determined by the same method. The peak area was calculated according to the external standard method.
Anti-tumor antibiotics.
shade, seal, and store in a cool place.
This product is a sterile freeze-dried product made of doxorubicin hydrochloride plus appropriate amount of lactose or other excipients. Doxorubicin hydrochloride containing (C27H29NO11 • HCl) shall be between 90.0% and 110.0% of the labeled amount.
This product should be orange-red loose lumps or powder.
This product was taken and the same results were shown according to the tests of (1) and (4) under the item of doxorubicin hydrochloride.
Take 10 bottles of this product, add mobile phase to dissolve and quantitatively dilute according to the indicated amount, and make it into about 0 ml per lml. 1 mg of the solution was measured as a test solution according to the method of doxorubicin hydrochloride, and the average content of 10 vials was determined.
Same as doxorubicin hydrochloride.
(l)lOmg (2)50mg
shade, close, and store in a cool place.
This product is Daunorubicin Hydrochloride and appropriate amount of mannitol or other excipients made of sterile lyophilized. Daunorubicin-containing (C27H29NO10) shall be between 90.0% and 110.0% of the labeled amount.
This product is a red loose block or powder.
take this product, according to Daunorubicin Hydrochloride under the identification of (1), (4) test, showed the same results.
Take 10 bottles of this product, add mobile phase to dissolve and quantitatively dilute to prepare about 0. 5% daunorubicin per 1 ml. 1 mg of the solution was used as a test solution, and the content of each bottle was measured according to the method of Daunorubicin Hydrochloride, and the average content of 10 bottles was obtained.
Same as Daunorubicin Hydrochloride.
20mg (based on C27H29NO10)
shade, close, and store in a cool place.