Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 24–Apr–2020
Official Date: 01–May–2021
Expert Committee: Excipient Monographs 2
Coordinating Pharmacopoeia: USP
The revision to the harmonized standard for Sodium Lauryl Sulfate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 4 (former Stage 6) of the PDG process, the Sodium Lauryl Sulfate monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.
The changes from the current Sodium Lauryl Sulfate monograph include:
- Identification A
- This will be no longer be a USP local requirement, and has been added to the PDG harmonized monograph.
- Identification D and Identification E
- PDG agreed to eliminate these two wet chemistry identification tests because of redundancy, after adding Identification A to the harmonized text.
- On the basis of comments received on the currently official PDG harmonized monograph as well as the supporting laboratory data, PDG agreed to modify the procedure by applying a different indicator to provide an improved end point determination of the titration.
- Sodium Chloride
- On the basis of queries received on the currently official PDG harmonized monograph, PDG agreed to add the following clarification for the titration “under vigorous stirring (to disperse silver chloride)” to help stakeholders determine the end point of titration.
- Sodium Sulfate
- Specify that both glass and porcelain filters with pore size equivalent to 4–10 µm can be used. In addition, add a clarification for the second step by stating “Collect the precipitate by filtration through a filter (maximum pore size of 16 µm) and...”.
- 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–NF 2021, Issue 1 (formerly known as USP 44–NF 39), from May 1, 2021.
Should you have any questions about the Sodium Lauryl Sulfate monograph, please contact Tong (Jenny) Liu (240-221-2072 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or email@example.com).
- Download the Sodium Lauryl Sulfate monograph – Stage 4
- Download the Sodium Lauryl Sulfate PDG sign-off documents: