Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 20–Nov–2015
Official Date: 01–Dec–2016
Expert Committee: Excipient Monographs 2
Coordinating Pharmacopoeia: European Pharmacopoeia
The new harmonized standard for Dextrose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the Dextrose monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the 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 was 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.”
- Chemical information
- Changed the CAS number for Dextrose Monohydrate from [5996-10-1] to [77938-63-7], because [5996-10-1] is an obsolete CAS number and [77938-63-7] is used for dextrose monohydrate in FDA inactive ingredient database.
- Modified the verbiage in accordance with PDG sign-off document.
- EP and JP refer to Dextrose as “Glucose” and have split the anhydrous and monohydrate forms into two separate monographs. USP will maintain one Dextrose monograph to incorporate both the anhydrous and monohydrate forms.
- Added Infrared, Chromatographic identity, and Water tests for ID test.
- Removed the ID test by color reaction.
- Added the new assay test by liquid chromatography.
- Added the new related substances test by liquid chromatography.
- Note: Standard solution B is diluted from Sample solution, according to the PDG sign-off document. This is a practice to use a dilution of the sample solution to quantify impurities.
- Added the new test in accordance with PDG sign-off document.
- Replaced the previous method with the harmonized method.
- Modified the method and acceptance criteria in accordance with PDG sign-off document.
- Residue on ignition
- Optical rotation
- Water (removed from Specific tests, but added to Identification test)
- Deleted the Heavy Metals test. The official implementation date for this revision is January 1, 2018.
- Identification (ID)
- Related substances
- Color and Clarity of Solution
- Soluble Starch, Sulfite
- Removed the tests
- Heavy Metals
- Added the symbols to the non-harmonized attributes or local requirements: Identification test A (Infrared),Packaging and Storage and Labeling.
Additionally, the monograph has been edited to be consistent with the current USP style.
The Dextrose monograph will be incorporated into and become official with the Second Supplement to USP 39–NF 34. The official implementation date for the omission of the Heavy Metals test is January 1, 2018.
Should you have any questions about the Dextrose monograph, please contact Tong (Jenny) Liu (240-221-2072 or email@example.com). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or firstname.lastname@example.org).