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Certificate of Analysis: Biotin

This certificate of analysis summarizes the test results for a batch of biotin. The batch number is 16A26-H09-00319 with a weight of 10g. Tests were performed according to PH.EUR 8.8 standards and all results met requirements. Tests evaluated appearance, identification, solution properties, specific rotation, related substances, heavy metals, loss on drying, sulfated ash, and assay. The batch was approved and expires on August 14, 2018.

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Achmad Latief
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889 views1 page

Certificate of Analysis: Biotin

This certificate of analysis summarizes the test results for a batch of biotin. The batch number is 16A26-H09-00319 with a weight of 10g. Tests were performed according to PH.EUR 8.8 standards and all results met requirements. Tests evaluated appearance, identification, solution properties, specific rotation, related substances, heavy metals, loss on drying, sulfated ash, and assay. The batch was approved and expires on August 14, 2018.

Uploaded by

Achmad Latief
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

Certificate of Analysis

Product name: Biotin


Number of analysis: T0002709

Batch number / Weight: 16A26-H09-00319 / 10g


Producer Batch Number: CS11508010

Analysed according to: [Link] 8.8

Tests Requirement Result Unit Standard remark

Appearance White or almost white, crystalline powder or colourless crystals Conform


Identification A Conform Conform Ir-spectrum
Appearance of solution Clear and colourless Conform 1%m/V in alkaline solution
Specific optical rotation +89 - +93 +89,9 ° Dried, 1%m/V in alkaline solution
Related substances Conform Conform TLC
Heavy metals <= 10 < 10 ppm
Loss on drying <= 1,0 0,841 % 105°C oven
Sulfated ash <= 0,1 0,03 %
Assay 98,5 - 101,0 100,6 % Dried

Analysis performed by the authorized internal lab.

Release:
Vasileios Dimitroulis
Pharmacist - QA Manager / QP

02/02/2016

Expiration: 14-08-2018

Conclusion: APPROVED

This document has been produced electronically from our quality system and is valid without signature.

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