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Notification of Shodex™ Column COA Misdescriptions and Issue of Amended COA

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March 1st, 2022

SHOWA DENKO K.K.

Functional Chemical Division


Dear valued customers,

Thank you for purchasing and using Shodex™ products.

We notify that it has been revealed that some Shodex™ products manufactured in the past have errors in the inspection items “Plate Count” and "Asymmetry Factor (Fas)" provided in the Certificate of Analysis (COA). The cause was that when inspection analysis software was updated, wrong Plate Count and Fas calculation formulae were applied and the mistakes were not realized.

The result of recalculation confirmed that provided Plate Count and Fas values were within the product standard specifications. Regardless, we sincerely apologize for causing this error that may have led to lose your trust in our products.

We will issue amended COAs with correct values for the corresponding product that you purchased (please see below). Please kindly follow the “Inquiry form” to fill in the required items including the product name and serial number. Then, amended COA PDF file will be sent to the registered e-mail address.

[Corresponding period]
2017 – 2021

[To request the replacement]
Please fill-in the required items in "Inquiry Form".
Note:
1. Under the “Inquiries” field, please select [Purchase].
2. Under the “Product name – Serial number” field, please write the product name and the serial number of the item you purchased.
3. Under the “Details of inquiry” field, please mention "replacement COA requested".

[Corresponding products]
Please click the product name to check the serial number.

Asahipak NH2P-40 3E SUGAR KS-805 OHpak SB-802 HQ GPC KF-803L
Asahipak NH2P-50 4B SUGAR KS-806 OHpak SB-802.5 HQ GPC KF-804
Asahipak NH2P-50 4D SUGAR SZ5532 OHpak SB-803 HQ GPC KF-804L
Asahipak NH2P-50 4E SUGAR SC1211 OHpak SB-804 HQ GPC KF-805
SUGAR SC1011 EP SC1011-7F OHpak SB-805 HQ GPC KF-805L
SUGAR SC1821 SUGAR SH1011 OHpak SB-806 HQ GPC KF-806
SUGAR SP0810 SUGAR SH1821 OHpak SB-806M HQ GPC KF-806L
SUGAR KS-801 RSpak KC-811 GPC KF-801 GPC KF-806M
SUGAR KS-802 RSpak KC-811 6E GPC KF-802 GPC LF-804
SUGAR KS-803 IC SI-90 4E GPC KF-802.5
SUGAR KS-804 IC SI-50 4E GPC KF-803

Note: The serial number follows "Column No. (or No.)" on the product tag attached to the product body, "S/N" on the product outer box label, or "Column number" on the COA. Please check the 8-digit characters.

[About plate count calculation formulae]
There are multiple methods for calculating the number of theoretical plates (N), i.e., plate count. Typical examples are the "half width method" used by the Japanese Pharmacopoeia (JP) and the "tangent method" used by the United States Pharmacopeia (USP), each of which is defined as follows.



For Shodex™ products, as described on the Shodex homepage and product instruction manuals, “half width method” should had been adopted, however “tangent method” had been mistakenly applied during the stated period.

[About peak symetry calculation formulae]
Concerning peak symmetry, there are two major index. One is "Asymmetry Factor (Fas)" which is recommended by ASTM International, the world's largest organization of standards. Another one is "Symmetry Factor (S)" which is recommended by the United States Pharmacopeia. They are defined as follows.




For Shodex™ products, as described on the Shodex homepage and product instruction manuals, “Asymmetry Factor (Fas)” should had been adopted, however “Symmetry Factor (S)” had been mistakenly applied during the stated period.

[Measures to prevent recurrence]
The Plate Count and Fas formula in the analysis software have been revised and corrected to the ones that should had been applied.

Finally, we will endeavor to strengthen quality control furthermore in order to provide you reliable products that satisfy your analytical needs.