PRODUCT

Toremifene citrate

SPECIFICATION

Raw material

BATCH No.

201007

EXP.DATE

2024.10

REFERENCE

Export standard

QUANTITY

30.4 kg

Test items          

Quality requirements         

Results

【Description】

White or like white crystalline powder

White crystalline powder

Solubility

Freely soluble in pyridine and acetic acid(100), sparingly soluble in methanol, slightly soluble in ethanol, very slightly soluble in water, and practically insoluble in diethyl ether

Freely soluble in pyridine and acetic acid(100), sparingly soluble in methanol, slightly soluble in ethanol, very slightly soluble in water, and practically insoluble in diethyl ether

Melting point

159.0~163.0℃

159.5~161.0℃

【Identification】

(a)Positive reaction

Must comply

Complies

(b)Positive reaction

Must comply

Complies

(c) UV

There is the strongest absorption at the wavelength of 234~238nm and 275~278nm.

There is the strongest absorption at the wavelength of 237nm and 277nm.

(d) IR

There is absorption at 1741, 1703, 1585, 1241 and 706cm^-1 .

There is absorption at 1741, 1703, 1585, 1241 and 706cm^-1 .

【Purity】

(a) Relative substances

①E-isomer

≤0.5%

0,04%

②Total relative substances

≤1.0%

0.1%

(b)Heavy metals

≤10ppm

<10ppm

【Loss on drying】

≤1.0%

0.1%

Toluene

≤0.089%

0.3%

Acetone

≤0.5%

【Residue on ignition】

≤0.1%

0.01%

Total bacteria quantity

<100 cfu/g

<10 cfu/g

Mold total yeast

<20 cfu/g

<10 cfu/g

Escherichia coli

No detected

Not detected

【Assay】

≥98.5% (Calculated by C₂₆H₂₈ClNO ^.C₆H₈O₇)

100.0%

Conclusion:  The results comply with the requirements of the export standard.