Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 30–Nov–2018
Official Date: 01–Dec–2019
Expert Committee: Excipient Monographs 2
Coordinating Pharmacopeia: United States Pharmacopoeia
The revision to the harmonized standard for Microcrystalline Cellulose 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 Microcrystalline 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.
The changes from the current Microcrystalline Cellulose 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 an Identification A test using infrared absorption. Changed the original Identification A and Identification B tests to Identification B and Identification C, respectively.
- Due to the addition of Identification A by infrared absorption, changed the description in the Labeling accordingly to specify that the degree of polymerization is determined by Identification C.
- USP Reference Standards
- Added this section to include the Reference Standard for Microcrystalline Cellulose.
- Loss on Drying
- Added the symbols to the local requirement of USP: “or some other lower percentage, or is within a percentage range, as specified in the Labeling."
- Particle Size Distribution, Packaging and Storage, Labeling
- Added the symbols , because they are local requirements of USP.
- Additionally, the monograph has been edited to be consistent with the current USP style.
The Microcrystalline Cellulose monograph will be incorporated into and become official with the Second Supplement to the USP 42–NF 37.
Should you have any questions about the Microcrystalline Cellulose monograph, please contact Dr. 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).
- Download the Microcrystalline Cellulose monograph – Stage 4 (former Stage 6)
- Download the Microcrystalline Cellulose PDG Sign-Off Cover Pages:
- Previous Stage 6 posting in PF 30 (4), 2004