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Certificate of Analysis

COANO.: 18011680
Product: Acid Analysis Standard: BP20l7/USP40
Batch Number: 1171150145 Quantity: 3000kg
Manufacture Date: Nov. 15, 2017 Expiry Date: Nov. 14, 2020

Analysis contents Analysis standard Analysis results


Characteristics White or almost white crystalline Pass

powder or colourless crystals


Identification Positive reaction Pass
Melting point About 1900C 1900C
Specific rotation
+20.5°~+21.5° +21.0°
pH
2.l~2.6
2.4
Residue on ignition
≤0.1% 0.03%
Assay
99.8%
Clarity of solution 99.0%~100.5%
Color of solution Clear Pass
lmpurity E < BY7
Heavy metals ≤BY7
<0.2%
≤0.2%
Copper <l0ppm
Iron ≤l0ppm
<5ppm
Loss on trying ≤5ppm
<2ppm
Lead ≤2ppm
<0.15%
≤0.15%
<2ppm
≤2ppm

Residual solvents Meets requirement Pass


Conclusion: The above product conforms with BP2017/USP40 standard.

QC Manager ong Qiuyun Rechecker Wu Yunyan Writer Zhang Liu


Manufacturer: CSPC Weisheng Pharmaceutical (Shijiazhuang) Co., Ltd.
ADD: NO.236 Huanghe Street High-Tech Industrial Development Zone, Shijiazhuang City,
Hebei Province. China