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Biotin COA

The Certificate of Analysis for Biotin (Batch Number CS1-2107009) confirms that the product meets all specified standards, including a 99.0% assay and compliance with impurity limits. The analysis shows that the product is a practically white crystalline powder with acceptable solubility and no detected impurities. All microbiological tests returned negative results, ensuring the product's safety and quality until its expiry date of July 2, 2024.

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Ameer HäMzâ
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665 views1 page

Biotin COA

The Certificate of Analysis for Biotin (Batch Number CS1-2107009) confirms that the product meets all specified standards, including a 99.0% assay and compliance with impurity limits. The analysis shows that the product is a practically white crystalline powder with acceptable solubility and no detected impurities. All microbiological tests returned negative results, ensuring the product's safety and quality until its expiry date of July 2, 2024.

Uploaded by

Ameer HäMzâ
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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CERTIFICATE OF ANALYSIS

Product Name Biotin


Manufacture
Batch Number CS1-2107009 Jul.03,2021
Date
Quantity 30kg Expiry Date Jul.02,2024

ITEMS STANDARDS RESULTS


Practically white, crystalline powder.
Very slightly soluble in water and in
Description and
alcohol; Conform
Solubility
Insoluble in other common organic
solvents
To match with the reference IR
Infrared Absorption Conform
spectrum
Specific Optical Rotation Meet the requirements Conform
The retention time of the major peak of
the Sample solution corresponds to that
HPLC Conform
of the Standard solution, as obtained in
the Assay.
Assay 97.5%~102.0% 99.0%
Individual Impurity NMT1.0% Not-detected
Total Impurities NMT2.0% Not-detected
Optical Rotation +89°~+93° +90.8°
Residual Solvents
NMT 890ppm NMT 20ppm
(Toluene)
Melting Range 229~232℃ 231.1℃
Lead NMT2ppm NMT0.5ppm
Arsenic NMT1ppm NMT0.5ppm
Cadmium NMT1ppm NMT0.5ppm
Mercury NMT0.1ppm NMT0.05ppm
Total plate count NMT100cfu/g NMT10cfu/g
Yeast & Mold NMT50cfu/g NMT10cfu/g
Staphylococcus aureus Negative Negative
Escherichia coli Negative Negative
Coliforms Negative Negative
Salmonella Negative Negative
Conclusion Conform to the standard.
QC: QA:

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