Petrolatum

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 27-Sep-2024
Official Date: 01–Aug-2025
Expert Committee: Complex Excipients Expert Committee
Coordinating Pharmacopeia: United States Pharmacopoeia  

A new harmonized standard for Petrolatum 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 Petrolatum monograph has been formally approved by the USP Complex Excipients Expert Committee in accordance with the Rules and Procedures of the 2020 – 2025 Council of Experts.

Changes from the existing monograph include:

  1. At the beginning of the monograph, add the general statement to indicate that this is a harmonization chapter: "Portions of the chapter text that are national USP text, and are not part of the harmonized text, are marked with symbols (⧫⧫) to specify this fact."
  2. Definition. Updated to align with the PDG harmonized text.
  3. Added a new Identification section including the following tests:
    • Identification A — Infrared Spectroscopy <197F>
    • Identification B — Color. This test is moved from “Specific Tests” section to “Identification” section to distinguish Petrolatum from White Petrolatum. Added another criterion: “In addition, the petrolatum is equal or darker than a mixture of ferric chloride CS: 10 mg/mL of hydrochloride acid (1:9) measured under these conditions.”
    • Identification C — Drop Point
    • [Note: Since wax materials do not go through a sharp solid-liquid phase change when heated and therefore do not have a true melting point, drop point test is added. To avoid using a mercury thermometer, an automated drop point test method is recommended.]
  4. Residue on Ignition. Bunsen flame is not used to avoid safety hazard. Added an additional description of "ignite at 600 ± 50° in the presence of sulfuric acid until constant weight". Also changed the acceptance criteria to “NMT 0.05%”.
  5. Deleted Organic Impurities test as a new UV Absorbance Limit for Polycyclic Aromatic Hydrocarbons test is added.
  6. Added a new test UV Absorbance Limit for Polycyclic Aromatic Hydrocarbons to detect these toxic carcinogens.
  7. Deleted Specific Gravity test as this test is not specific.
  8. Deleted Melting Range or Temperature, Class III test as a new Drop Point test is added.
  9. Consistency. Expand the range of diameter and length of apparatus to cover parameters from different regions. In addition, deleted the requirement - “and conduct further trials to a total of 10 if the individual results differ from the average by more than ±3%”.
  10. Deleted Alkalinity and Acidity tests and added a new Acidity or Alkalinity test.
  11. Deleted Fixed Oils, Fats, and Rosin test to align with the PDG sign-off document.
  12. Labeling. Added "Label to state the drop point value of the product."
  13. Added diamond symbols (⧫⧫) to Packaging and Storage and Labeling as they are non-harmonized attributes.
  14. USP Reference Standards Added this section for USP Petrolatum RS and USP Naphthalene RS that are used in the Infrared Spectroscopy test and Polycyclic Aromatic Hydrocarbons test, respectively.
  15. Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Petrolatum monograph will be incorporated into and become official on August 1, 2025.

Should you have any questions about the Petrolatum monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization website or contact Mr. Richard Lew at (240-221-2060 or rll@usp.org).