Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 25–Sep–2015
Official Date: 01–Aug–2016
Expert Committee: Monographs—Excipients
Coordinating Pharmacopoeia: European Pharmacopoeia
The correction to the harmonized standard for Gelatin has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Gelatin monograph has been formally approved by the Monographs—Excipients 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.”
- Added the note: “All tests in this monograph are harmonized attributes based on PDG sign-off documents for both gelling and non-gelling grades.”
- Peroxides in Specific tests
- Corrected the Suitability test concentration for Peroxide test from “10 ppm” to “2 ppm”.
- Identification C: changed “chloramine” to “chloramine T” in order to describe the reagent properly.
- Sulfur Dioxide: changed statement “a 1-g/L solution of bromophenol blue in alcohol (20% v/v)” to “Bromophenol Blue TS” which is a listed Test Solution (TS) in USP–NF.
- Chromium: added “potassium dichromate” in front of “(K2Cr2O7)”.
- Some clarifications:
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 First Supplement to USP 39–NF 34.
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 6
- Download the Gelatin PDG sign-off documents:
- 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 posting: Gelatin Revision Bulletin (posted 28–Sep–2012; official 01–Apr–2013)