- A new monograph for Octyldodecanol, NF went into effect in December 15, 2015
- To our knowledge, only recent batches of JARCOLTM I-20P Octyldodecanol, NF meet the current monograph in commercial quantities
- A new monograph, USP 40-NF 35, with more appropriate test protocols and limits, was developed and will become official January 1st, 2017
- JARCHEM’s JARCOL™ I-20P Octyldodecanol, NF will meet the new monograph
- JARCHEM’s JARCOL™ I-20P Octyldodecanol, NF will meet the stricter Test 1 protocols of the new monograph and will not require special labeling
As some of you may be aware…
Over the past few years the USP has been updating monographs to better quantify the purity and “impurities” of various excipients. In December of 2015, in the 2nd Supplement to USP 38-NF 33, a NMT 10.0% limit for “unspecified impurities and related alcohols” and a NMT 1% limit for “Unspecified Impurities” was added to the existing NLT 90% limit for 2-Octyldodecanol.
Inadvertently the “related alcohols” specified were not the co-alcohols produced by the 2-Octyldodecanol manufacturing process. As a result all co-products were considered to be “Unspecified Impurities” subject to the NMT 1% limit.
JARCHEM has produced Jarcol™ I-20P Octyldodecanol, NF meeting the current 2nd Supplement monograph. However it was agreed that the limits were uneconomical and inappropriate.
Now there is an upcoming new USP Monograph for Octyldodecanol
The USP developed a new monograph testing for appropriate “related chemicals”. Specifically two alkanes, three fatty alcohols, and four branched alcohols. Based on demonstrated manufacturing performance, a limit of NMT 1.5% was set for these “Related Alcohols and Alkanes”. It should be noted that, combined with the NMT 1% limit on “Unspecified Impurities”, this does make the effective purity requirement for Octyldodecanol , NF NLT 97.5%.
JARCHEM’s Jarcol™ I-20P Octyldodecanol, NF will meet the new USP 40-NF 35, becoming official January 1st, 2017.
In order to allow for the use of this lower purity version of Octyldodecanol, NF, a second test method, with higher impurity limits, was developed. Octyldodecanol, NF tested against method two requires additional labeling.
JARCHEM will use Organic Impurity Test 1 and therefore Jarcol™ I-20P (Octyldodecanol, NF) requires no special labels. JARCHEM also carries Technical Grade and Cosmetic Grade Octyldodecanol, Jarcol™ I-20 and Jarcol™ I-20CG, respectively.