Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 26–Apr–2019
Official Date: 01–May–2020
Expert Committee: Excipient Monographs 2
Coordinating Pharmacopoeia: European Pharmacopoeia
The revision to the harmonized standard for Gelatin 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 Gelatin 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 current Gelatin monograph include:
- Definition. Added the symbols to USP local text “(including fish and poultry)”, and aligned the description with the PDG sign-off document.
- Identification C. Changed the temperature from "0°" to "2° - 8°", based on the stakeholder's request and the agreement with the PDG. It was observed that some type of non-gelling gelatin cannot flow out immediately at 0° due to high viscosity of the gelatin solution.
- Identification D. Changed the acceptance criteria from “A red color develops” to “A red to violet color develops” based on the observation and request from stakeholders.
- Sulfur Dioxide. Described the Titrant as “0.1 N sodium hydroxide VS” according to USP style.Download the Gelatin monograph – Stage 4
Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Gelatin monograph will be incorporated into and become official in the USP 43–NF 38.
Should you have any questions about the Gelatin 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).
- Download the Gelatin monograph – Stage 4
- Download the Gelatin PDG sign-off documents:
- Oct. 3, 2018, Rev. 2 for gelling grade and non-gelling grade, respectively.
- Oct. 26, 2016, Corr. 3 to sign-off cover sheet for gelling grade and non-gelling grade, respectively.
- Jun. 26, 2014, Corr. 2 (erratum) for gelling grade and non-gelling grade, respectively.
- Nov. 6, 2013, Corr. 2 for gelling grade and non-gelling grade, respectively.
- Nov. 7, 2012, Corr. 1 for gelling grade and non-gelling grade, respectively.
- Jun. 6, 2012, for gelling grade and non-gelling grade, respectively.
- Correction 1 (sign off on Nov. 7, 2012): Correction to Peroxides test (10 ppm replaced by 2 ppm)
- Correction 2 (sign off on Nov. 6, 2013): Included descriptions of AA methods for Iron, Chromium, and Zinc, but the correction for the Peroxides test was inadvertently not included (10 ppm not replaced by 2 ppm)
- Correction 2 (erratum) (sign off on Jun. 26, 2014): Correction to the Correction 2 (sign-off dated Nov. 6, 2013) by re-implementing the correction for the Peroxide test (10 ppm replaced by 2 ppm).
Previous Stage 4 (former Stage 6) web posting (posted 25-Sep-2015; official 01-Aug-2016)
Previous posting: Gelatin Revision Bulletin (posted 28–Sep–2012; official 01–Apr–2013)