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Shandong Luwei Pharmaceutical Co.,Ltd.: Shuangfeng Industrial Park, Zichuan District, Zibo City, Shandong, China

This document provides a certificate of analysis for a 5000kg batch of ascorbic acid produced by Shandong Luwei Pharmaceutical Co., Ltd. in August 2018. It lists the product and batch details and results of tests for characteristics, identification, purity, heavy metals, residual solvents and assay that confirm the ascorbic acid meets BP2016/USP39 standards. The tests all showed results within specified limits.

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Souheila Mni
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452 views1 page

Shandong Luwei Pharmaceutical Co.,Ltd.: Shuangfeng Industrial Park, Zichuan District, Zibo City, Shandong, China

This document provides a certificate of analysis for a 5000kg batch of ascorbic acid produced by Shandong Luwei Pharmaceutical Co., Ltd. in August 2018. It lists the product and batch details and results of tests for characteristics, identification, purity, heavy metals, residual solvents and assay that confirm the ascorbic acid meets BP2016/USP39 standards. The tests all showed results within specified limits.

Uploaded by

Souheila Mni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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SHANDONG LUWEI PHARMACEUTICAL CO.,LTD.

Shuangfeng Industrial Park,Zichuan District,Zibo City,Shandong,China

Product Name ASCORBIC ACID Batch No. 180132059

Analysis Standard BP2016/USP39 Quantity 5000KGS

Manufacture Date AUG.2018 Expiry Date JUL.2021

Analysis Contents Analysis Standard Analysis Results

White or almost White


Characteristics Pass
crystals Crystalline Powder
Identification Positive Reaction Positive
Melting Point About 190 190.2
PH(with 2% water solution) 2.4-2.8 2.53
PH(with 5% water solution) 2.1-2.6 2.39
Clarity Of Solution Clear Clear
Colour Of Solution BY7 <BY7
Copper 5ppm <5ppm
Heavy Metals 10ppm <10ppm
Mercury 0.1mg/kg <0.1mg/kg

Lead 2ppm <2ppm

Arsenic 3ppm <3ppm


Oxalic Acid 0.2% <0.2%
Iron 2ppm <2ppm
Impurity E 0.2% <0.2%

Loss of Drying 0.4% <0.4%

Sulphate Ash(Residue On Ignition) 0.1% <0.1%

Specific Optical Rotation +20.5 +21.5 +21.01

Residual Solvents Pass Pass

Assay 99.0%-100.5% 99.77%


The Above-Mentioned Product Conforms To
Conclusion BP2016/USP39

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