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Notification of Shodex™ Out-of-spec Products and Their Replacements

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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 had errors in the inspection item "asymmetry factor (Fas)" which describes the separation ability of the product. The cause was that when inspection analysis software was updated, wrong Fas calculation formula was applied and the mistake was not realized. The result of recalculation confirmed that some products were not meeting the required specification.

We will provide new product that meeting the required specifications to replace the corresponding products. Please access below Shodex web site and check if you have any of the corresponding products with mentioned serial numbers. If you have the corresponding product, please kindly follow the “Inquiry form” and fill in the required items. Then, we will arrange to send you replacement product(s) to the registered address.

We sincerely apologies for the inconvenience this may have caused. We will endeavor to strengthen the quality control to prevent the similar mistakes to reoccur and provide you reliable products that satisfy your analytical needs.

[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 column requested".

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

Asahipak NH2P-40 3E SUGAR KS-802 OHpak SB-803 HQ GPC KF-803L
Asahipak NH2P-50 4B SUGAR KS-803 OHpak SB-804 HQ GPC KF-805
Asahipak NH2P-50 4D SUGAR KS-804 OHpak SB-805 HQ GPC KF-805L
Asahipak NH2P-50 4E SUGAR SZ5532 OHpak SB-806 HQ GPC KF-806L
IC SI-90 4E SUGAR SH1821 OHpak SB-806M HQ GPC KF-806M
SUGAR SP0810 OHpak SB-802 HQ GPC KF-802 GPC LF-804
SUGAR KS-801 OHpak SB-802.5 HQ GPC KF-802.5

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 Certificate of Analysis. Please check the 8-digit characters.

[Details on out-of-spec products]
Fas is an index that measures the left-right symmetry of peak shapes in chromatograms. The peak symmetry reflects the uniformity of packing material in HPLC columns. Especially when the packing material is filled sparse (non-uniformly filled) in the flow direction, the base of the peak spreads to front or back, and thus symmetry will decrease. For two peaks that elute at similar timings, if their bases are wide, they may overlap with each other. This may alter their peak area calculations, and consequently leads to incorrect quantification results. Therefore, Fas is one of the important factors when evaluating the separation ability of HPLC columns.
Concerning peak symmetry, there are two major indexes. 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 below.



For Shodex™ products, as described on the Shodex homepage and product instruction manuals, “Asymmetry Factor” should had been adopted, however “Symmetry Factor” had been mistakenly applied during the stated period. The result of recalculation confirmed that some products were not meeting the required specifications, but released for sales.

[Measures to prevent recurrence]
The Fas formula in the analysis software have been revised and corrected to the ones that should had been applied. We will provide you replacement columns meeting the required specifications and ask you to return the out-of-spec product at our expense of the shipment. We again apologies for the inconvenience this may cause.

Please fill-in the required items in "Inquiry Form".