Pharmaceutical APIs

Appearance: White or off white powder;
Solubility: This product is easily soluble in dichloromethane; Dissolve in N, N-dimethylformamide or methanol; Slightly soluble in acetonitrile; Almost insoluble or insoluble in water, 0.1mol/L hydrochloric acid solution, and 0.1mol/L sodium hydroxide solution.
Melting point: should be 143~147 ℃
Specific rotation: should be -47 º to -52 º
Moisture content: not exceeding 0.25%;
Burning residue: not exceeding 0.2%;
Heavy metals: not exceeding 20ppm;
Related substances: Single impurities shall not exceed 0.1%; The total impurities shall not exceed 0.5%;
Palladium: not exceeding 10ppm
Content: should be between 98.0% and 102.0% (based on dry product).

Abiraterone acetate (trade name ZYTIGA) is a CYP17 inhibitor that blocks androgen production in testicular, adrenal, and prostate cancer tissues by inhibiting the key enzyme 17 α – hydroxylase/C17,20-lyase involved in androgen synthesis. This drug needs to be used in combination with prednisone and is suitable for treating metastatic castration resistant prostate cancer that has previously received chemotherapy containing docetaxel. The standard dose is 1000mg orally on an empty stomach per day, and patients with liver function impairment need to adjust the dose.

Appearance: off white to off white powder;
Solubility: soluble in methanol, slightly soluble in water, insoluble in acetone, ethanol or ether;
Specific rotation: should be+96.0 °~+100.0 °;
Chloride: ≤ 0.04%;
Regarding substances: Impurity A should not exceed 0.3%. Impurity B shall not exceed 0.3%. Impurities D and E shall not exceed 0.2%, unknown individual impurities shall not exceed 0.05%, and total impurities shall not exceed 0.5%;
Moisture content: ≤ 0.3%;
Burning residue: ≤ 0.1%;
Heavy metals: ≤ 20ppm;
Content: 98.0%~102.0%;

Appearance: This product is colorless, transparent crystalline or crystalline fine particles; Odorless; It is weathered in dry air and deliquescent in humid air; Weak alkaline reaction in aqueous solution;
Solubility: Highly soluble in water, insoluble in ethanol;
PH: 6.0-8.4;
Sulfate and sulfite: not exceeding 0.2%;
Sulfide: not exceeding 0.0005%
Related substances: The sulfite radical shall not exceed 0.15%, the tetrasulfate radical shall not exceed 0.15%, the maximum single impurity shall not exceed 0.10%, and the total impurity shall not exceed 0.50%;
Dry weight loss: 32.0%~37.0%;
Calcium salts: turbidity should not occur;
Heavy metals: not exceeding 0.002%;
Arsenic salt: not exceeding 0.001%;
Content: Calculated as dry product, Na2S2O3 content shall not be less than 99.0%.
Appearance: This product is a colorless and clear oily liquid; Odorless or almost odorless.
Solubility: This product can be mixed freely in chloroform, ether, toluene, or xylene, and is insoluble in water or ethanol.
Relative density: 0.967~0.975 at 25 ℃.
Refractive index: 1.4013~1.4053 at 25 ℃.
Kinematic viscosity: 500~1000mm2/s at 25 ℃.
PH: Adding sodium hydroxide titrant should result in a slight pink color, while adding sulfuric acid titrant should cause the pink color to disappear.
Mineral oil: The fluorescence intensity of this product should not be deeper compared to the control solution at 365nm ultraviolet.
Benzoate: The absorbance should not exceed 0.2.
Regarding substances: Impurities D3, D4, D6, MM, D5 should not exceed 0.10%, other individual unknown impurities should not exceed 0.10%, and total impurities should not exceed 0.5%.
Dry weight loss: not exceeding 0.5%.
Heavy metals: not exceeding 0.0005%
Arsenic salt: not exceeding 0.0002%.
Molecular weight distribution: The weight average molecular weight (Mw) should be between 20000 and 40000, and the distribution coefficient should not exceed 2.5.
Content: The content of polydimethylsiloxane should be between 97.0% and 103.0%.

Appearance: This product is a yellow powder or crystalline powder, odorless.
This product is slightly soluble in N, N-dimethylformamide and almost insoluble in water, ethanol, or ether.
Acidity: The pH value should be between 5.5 and 7.0.
Dissolved substances in ethanol: residual residue should not exceed 0.5%.
5-Nitrofurfural diacetate: not exceeding 1.0%.
Dry weight loss: not exceeding 0.5%.
Burning residue: not exceeding 0.2%
Heavy metals: not exceeding 20 parts per million.
Content: should be between 97.0% and 103.0%.