產品名稱

PRODUCT NAME

比卡魯胺

BICALUTAMIDE

CAS號

CAS NO

90357-06-5

批號

BATCH NO

20220601

報告日期

REPORT DATE

2022-09-10

包裝

PACKAGING

25kg/桶

25KG/DRUM

制造日期

MANUFACTURING DATE

2022-06-04

批量

BATCH SIZE

102.5kg

復測日期

RETEST DATE

2025-06-03

標準

SPECIFICATION

USP43

檢測項目

TEST ITEMS

標準

SPECIFICATION

結果

RESULTS

外觀

Appearance

白色至類白色粉末

White to off-white powder

白色粉末

White powder

溶解性

Solubility

在四氫呋喃和丙酮中易溶；在乙腈中溶解；在甲醇中略溶；乙醇中微溶。

Free soluble in tetrahydrofuran and in acetone;soluble in acetonitrile;sparingly soluble in methanol slightly soluble in alcohol.

符合

Conform

鑒別

Identification

A.紅外光譜：紅外吸收分光光度法確認

A.Infrared spectrum:Infrared absorption apectrohotometry confirm

B.HPLC：樣品光譜與標準相對應

B.HPLC:The sample spectrum corresponds to standard

符合

Conform

符合

Conform

熾灼殘渣

Residue on ignition

NMT0.1%

0.05%

水分Water

NMT0.2%

0.18%

有機雜質

Organic impurities

比卡魯胺氨基芐腈NMT0.1%

Bicalutamide aminobenzonitrile NMT0.1%

未檢測出

Not Detected

比卡魯胺相關化合物A異構體A NMT0.1%

Bicalutamide relate compound A isomer A NMT0.1%

未檢測出

Not Detected

比卡魯胺相關化合物A異構體b NMT0.1%

Bicalutamide relate compound A isomer b NMT0.1%

0.03%

去氟比卡魯胺NMT0.2%

Desfluoro bicalutamide NMT0.2%

0.004%

2-氟比卡魯胺NMT0.2%

2-Fluoro bicalutamide NMT0.2%

未檢測出

Not Detected

脫氧比卡魯胺NMT0.2%

Deoxybicalutamide NMT0.2%

0.06%

硫化比卡魯胺NMT0.1%

Bicalutamide sulfide NMT0.1%

0.01%

任何未指明雜質NMT0.1%

Any unspecified impurity NMT0.1%

0.01%

總雜質

Total impurities NMT0.5%

0.12%

殘留溶劑

Residual solvent

方法1:DMAC≤0.109%

Method 1:DMAC≤0.109%

未檢測出

Not Detected

方法2：乙醇≤0.1%

Method 2:Ethanol≤0.1%

二氯甲烷≤0.03%

dichloromethane≤0.03%

乙酸乙酯≤0.1%   

Ethyl acetate≤0.1%

MIBK≤0.1%

0.02%

未檢測出

Not Detected

未檢測出

Not Detected

未檢測出

Not Detected

方法3：石油醚≤0.1%

Method 3:Petroleum ether≤0.1%

未檢測出

Not Detected

方法4：苯≤0.0002%

Method 4:Benzene≤0.0002%

未檢測出

Not Detected

含量測定（以無水物為基礎）

Assay(on the anhydrous basis)

98.0% to 102.0%

100.3%