山东 科汇药业有限公司

Shandong Kehui Pharmaceutical Co., Ltd.

No. 9A1, Tianheng Road, Changjia Town, Gaoqing County, Zibo City, Shandong Province., China

CERTIFICATE OF ANALYSIS
Product Name Elacestrant dihydrochloride Batch number ELD240101
Mfg. date 02-01-2024 EXP. date 01-01-2026
Quantity 100g Test date 03-01-2024
Structure

CAS number: 722533-56-4

Molecular formula: C30H38N2O2
Molecular weight: 458.63
ITEMS STANDARDS RESULTS
Appearance White to off-white powder Conform
Solubility water :. Freely soluble Conforms
methanol : Freely soluble
Ethanol:insoluble
Acetone: insoluble
Ethyl acetate:insoluble
Dichloromethane:_ insoluble
Tetrahydrofuran: insoluble
N-heptane: insoluble
Acetonitrile: insoluble
Identification IR: IR spectrum obtained should correspond to the Conforms
spectrum of reference standard.
HPLC:The retention time of the major peak in the Conforms
Sample Preparation should correspond to that of the
Standard Preparation, as obtained in the Assay.
S-Enantiomer ≤1.0% 0.44%
Specific rotation +30.0°~+40.0° +35.9°
PSD ≤10um 6.3um
Crystal form IB Conforms
Water ≤1.0% 0.23%
Residue on ≤ 0.1% 0.23%
ignition
 Acetic acid≤0.1% ND

Related Chloride 13.2%~13.5% 13.3%

substances The maximum single impurity≤0.5% 0.16%
Total impurities ≤1.0% 0.61%
Tetrahydrofuran NMT 720ppm Conforms
Methanol NMT 3000ppm Conforms
Residual solvents Tert butyl methyl ether NMT 5000ppm Conforms
Ethanol NMT 5000ppm Conforms
Ethyl acetate NMT 5000ppm Conforms
Residule on
≤0.2% 0.06%
ignition
Heavy metals ≤ 20ppm <20ppm
Assay by HPLC 98%~102%(Calculated on anhydrous & solvent free 99.39%
basis)
Bulk Density ≤0.6 g/cc Confirm
Tapped density ≤0.6 g/cc Confirm
Microbial limits Aerobic bacteria per 1g must not exceed the total <102cfu
number of 103cfu
Fungi and yeast per 1g must not exceed 102 cfu <10 cfu
Escherichia coli per 1g must not be detected ND
Conclusion This batch of product conforms to the specification.
Storage Store the container tightly closed in a dry, cool and well-ventilated place. Store
conditions apart from foodstuff containers or incompatible materials.