Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 24–Apr–2015; updated 29–Apr–2015*
Official Date: 01–May–2016
Expert Committee: Monographs—Excipients
Coordinating Pharmacopoeia: USP
A new harmonized standard for Sodium Lauryl Sulfate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Sodium Lauryl Sulfate monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.
On April 1, 2015 USP revised General Notices: Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements via a Revision Bulletin which established January 1, 2018 as the new date of applicability of General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements. This new date is intended to align the implementation of General Chapter <232> more closely with that of the ICH Q3D Guideline for Elemental Impurities. The implementation of General Chapters <232> and <2232> will coincide with the removal of all references to General Chapter <231> Heavy Metals from monographs and General Chapters in the USP–NF. Accordingly, the reference to General Chapter <231> Heavy Metals in this monograph is omitted with an official implementation date of January 1, 2018, as indicated in the recently revised General Notices. For further details see General Chapter <231> Heavy Metals and Affected Monographs and General Chapters Revision Bulletin.
Changes from the existing USP–NF monograph include:
- In the beginning of the monograph,
- Added the statement: “Portions of this monograph that are national USP text, and are not part of the harmonized text, are marked with symbols to specify this fact.”
- Added the sentence “It contains NLT 85.0% of sodium alkyl sulfates calculated as C12H25NaO4S.”
- Added a Description of the modified procedure in detail for Identification test A and B.
- Added Identification tests C and D
- Added a test for Content of Sodium Alkyl Sulfate
- The Benzethonium chloride reagent and Volumetric Solution will be proposed in the Pharmacopeial Forum 41(3) [May–Jun. 2015].
- Sodium Chloride
- Added a solution preparation procedure and modified the analysis procedure.
- Added the acceptance criteria: “The combined content of sodium chloride and sodium sulfate is NMT 8.0%.”
- Sodium Sulfate
- Moved this test from the Specific Tests section to the Impurities section.
- Modified the procedure by using Barium chloride test solution instead of Lead nitrate test solution.
- Revised the verbiage in the acceptance criteria.
- Specified the volume of the phenol red solution as 0.1 mL
- Tightened the limit from 0.60 mL to 0.5 mL for neutralization.
- Unsulfated Alcohols
- Replaced solvent hexane with petroleum ether.
- Heavy Metals
- Deleted the Heavy Metals test. The official implementation date for this revision is January 1, 2018.
- Added the symbols to the following non-harmonized section or local requirement: Total Alcohols, Packaging and Storage.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Sodium Lauryl Sulfate monograph will be incorporated into and become official in USP 39–NF 34.
Should you have any questions about the Sodium Lauryl Sulfate monograph, please contact Kevin Moore (301-816-8369 or email@example.com). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization website or contact Emily Meyer (301-230-7438 or firstname.lastname@example.org).
- Download the Sodium Lauryl Sulfate monograph – Stage 6
- Download the Sodium Lauryl Sulfate PDG sign-off documents:
*The Sodium Lauryl Sulfate monograph that was posted on April 24, 2015 had an incorrect official date of May 1, 2015, instead of May 1, 2016. A corrected version of the PDF was posted on April 29, 2015.