Lucideon Helps Pharmaceutical Manufacturers to Meet Revisions to USP

Thanks to investment in a new ICP-MS, Lucideon is now able to offer pharmaceutical manufacturers testing services to meet the forthcoming revisions to the ‘Heavy Metals Test’ used in the United States Pharmacopeia/National Formulary (USP/NF) <231>.

The revisions will see Elemental Impurities General Chapters <232> (Elemental Impurities – Limits) and <233> (Elemental Impurities – Procedures) replace <231>.  The existing 100 year old method assumes all analytes behave in a similar manner to a Lead standard, an assumption that is often incorrect. 

The new methodology will rely on modern analytical techniques and establish new toxicologically relevant limits for impurities.

Using ICP-MS (Inductively Coupled Plasma Mass Spectrometry) Lucideon’s experts are able to provide the elemental analysis that will be required to meet all pharmacopeia requirements in line with the revision of the General Chapters.

ICP-MS allows the identification of elements by their individual masses and isotopic fingerprints, with detection limits as low as parts per trillion (ppt).

Aia Malik, Product Manager, Healthcare, at Lucideon, said:

“The date of applicability of the revision has been set as 1 January 2018, and USP is allowing and even encouraging early adoption of the General Chapters.  This is because the new testing methodology is in the interest of the public health and provides significant improvements over existing approaches in the detection of elemental impurities.”

Lucideon offers a range of services to the pharmaceutical industry, including quality control testing, method development and validation.  The Healthcare Technologies Division also provides a range of technology platforms for drug delivery of oral formulations, including a controlled release technology, and iCRT-deter, an abuse deterrent platform.

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    ASTM A967