Type of Posting: Sodium Chloride Notice of Adoption of Harmonized Standard
Posting Date: 20–Nov–2015
Official Date: 01–Dec–2016
Expert Committee: Excipient Monographs 2
Coordinating Pharmacopeia: European Pharmacopoeia
The revision to the harmonized standard for Sodium Chloride 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 Sodium Chloride monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.
This is to make a correction to the previous Stage 6 posting on November 21, 2014:
- In the beginning of the test, the note states that all solutions used for this test must be prepared with distilled water, because the content of various ions could influence the degree of opalescence obtained in the test; however, it does not mean distilled water is the solely solvent for preparation of solutions.
- It was incorrect to omit the Standard sulfate solution A preparation procedure in the Stage 6 posted on November 21, 2014. The test procedure published in the First Supplement to USP 38–NF 33 was correct. This Stage 6 posting will supersede the Sodium Chloride monograph in the Second Supplement to USP 38–NF 33.
The explanation is as below:
The solubility of Barium Sulfate varies dramatically with particle size. In order to give a precipitate of well-defined particle size distribution, a small amount of Standard sulfate solution A in 30% alcohol is added to excess amount of Barium reagent to give a fast precipitation with smaller particles at first. This seeding step greatly enhances the sensitivity and reproducibility of the test. After the seeding step, sample solution is added, thus a further precipitation occurs immediately.
- References affected by revision to General Chapter <851> Spectrophotometry and Light-Scattering
- As specified in the Compendial Notice Monographs and General Chapters Affected by Revision to General Chapter <851> Spectrophotometry and Light-Scattering posted on October 31, 2014 and updated on May 8, 2015, the omission of General Chapter <851> and associated reference changes will appear in USP 39–NF 34, which will be released on November 1, 2015 and become official on May 1, 2016. Although the new general chapters, <852>, <853>, <854>, <855>, <857> may already be official, they will not be applicable, until May 1, 2016 when the references in the associated monographs become official. For the following tests please reference the General Chapters indicated below:
- Aluminum – Refer to <853> Fluorescence Spectroscopy
- Limit of Bromides – Refer to <857> Ultraviolet-Visible Spectroscopy
- Limit of Potassium – Refer to <852> Atomic Absorption Spectroscopy
- Nitrites – Refer to <857> Ultraviolet-Visible Spectroscopy
The Sodium Chloride monograph will be incorporated into and become official with the Second Supplement to USP 39–NF 34. The new general chapters <852>, <853>, <857> will not be applicable until May 1, 2016.
Should you have any questions about the Sodium Chloride monograph, please contact Tong (Jenny) Liu (240-221-2072 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or email@example.com).
- Download the Sodium Chloride monograph – Stage 6
- Download the Sodium Chloride PDG sign-off documents:
- Previous Stage 6 web posting (posted 21–Nov–2014; official 01–Dec–2015)
- Previous Stage 6 posting in PF 30(2), 2004
- Previous Stage 6 posting in PF 28(4), 2002