Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: Sep–27–2019
Official Date: Aug–01–2020
Expert Committee: Excipient Monographs 2
Coordinating Pharmacopeia: European Pharmacopoeia
The new harmonized standard for Hydroxyethyl Cellulose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 4 of the PDG process, the Hydroxyethyl Cellulose monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.
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."
- Definition
- Revised to include the content limits for the hydroxyethoxy groups and use of suitable pH stabilizers.
- Identification
- Added a new test A with Infrared (IR) spectrophotometry using the attenuated transmission reflectance (ATR) technique according to the PDG sign-off document.
- Changed the original test A as test B, clarified the sample solution preparation procedure and revised the analysis from "heated to 60°" to "heat 10 mL of Sample solution to boiling".
- With the addition of IR, the original tests B and C were deleted.
- Assay
- A new assay test by capillary GC method is added. A suitable column is RTX-1, 0.53-mm × 30-m, 3-µm, G1 column from Restek. The retention time for internal standard (n-octane) is about 10 min.
- Apparatus - local text to have more detailed description for the stakeholders.
- Chlorides
- New test is added.
- Nitrates
- New test is added.
- Aldehydes
- New test is added.
- Residue on Ignition
- Changed the current test to include the use of viscosity testing for Nitrates and Residue on Ignition to determine the appropriate acceptance criteria.
- pH
- Changed acceptance Criteria from "6.0 – 8.5" to "5.5 – 8.5".
- Loss on Drying
- Sample amount of 1.000 g was added.
- Viscosity
- Changed to use rotational methods, Viscosity-Rotational Methods <912>. This is a non-harmonized attribute.
- In addition, for the purpose of determining applicable limit for the tests of Nitrates and Residue on Ignition, added a separate harmonized viscosity testing procedure.
- Labeling
- Included the statement of "The label states the name and concentration of any added pH-stabilizer." In addition, a correction from "average value" to "labeled value" was made to be consistent with the viscosity acceptance criteria.
- Added USP Reference Standards section to include USP Hydroxyethyl Cellulose RS and USP Sodium Chloride RS.
- Added symbols for Lead, Viscosity, Labeling and Package and Storage tests, because they are either non-harmonized attributes or local requirements for Hydroxyethyl Cellulose NF monograph.
- Additionally, the monograph has been edited to be consistent with the current USP style.
The Hydroxyethyl Cellulose monograph will be incorporated into USP-NF and become official from Aug. 1, 2020.
Should you have any questions about the Hydroxyethyl Cellulose monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization website or contact Richard Lew at (240-221-2060 or rll@usp.org).
- Download the Hydroxyethyl Cellulose monograph – Stage 4 | En español
- Download the Hydroxyethyl Cellulose PDG sign-off document: