pure mirtazapine powder in stock for sale

1. SHANDONG OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-15589503653 FAX:0086-0535-6715688 sales@octagonchem.com
Address: Rm 528, Building 2, No. 300-2, Changjiang Rd, YEDA, YanTai, ShanDong, China
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Product Mirtazapine (anhydrous)
Batch No. A1121905001 Mfg. date 2019.05.19
Rep. Date 2019.05.19 Exp. date 2022.05.18
Test Items Standard Result
Character White or almost white crystalline powder
Almost white crystalline
powder
Identification
A） The IR absorption spectrum is accordant with
the spectrum obtained with the reference standard
Conforms
B）
The RT of the major peak in the chromatogram of
the assay preparation corresponds to that of the
standard preparation, as obtained in the assay
Conforms
Specific rotation -2.0°～+2.0° -0.10°
Water ≤1.00% 0.27%
Residue on ignition ≤0.10% 0.03%
Heavy metals ≤0.001% Conforms
Residual solvents Ethanol≤5000ppm 44ppm
Related substances
Impurity A ≤0.10% <0.05%
Impurity B ≤0.10% <0.05%
Impurity C ≤0.10% <0.05%
Impurity D ≤0.10% <0.05%
Impurity E ≤0.10% <0.05%
Impurity F ≤0.10% <0.05%
Individual impurity≤0.10% <0.05%
Total impurities≤0.50% <0.05%
Assay 98.0～102.0%(anhydrous substance) 100.2%
Storage Store in a well-closed container at ambient temperature.
Conclusion The results conform with USP42
Prepared by: LI Reviewed by: WEI Released by: Zhang