T/ZNX 051-2024 5% Ivermectin Microemulsion

Scope

Main technical contents: **Project:** **Indicator:** - **Ivermectin concentration (%):** 4.5–5.5 - **Ivermectin concentration at 20°C (g/L):** 46–56 - **α-Ivermectin ratio (B1a/B1b):** ≥20.0 - **pH value:** 4.0–7.0 - **Emulsion stability (diluted 200 times):** No oil floating, settling, or precipitation in the graduated cylinder. - **Persistent foaming (foam volume after 1 minute):** ≤60 mL - **Low-temperature stability:** After cold storage, the volume of precipitate at the bottom of the centrifuge tube should not exceed 0.3 mL. - **Heat storage stability:** After heat storage, the ivermectin concentration should not be lower than 95% of the measured concentration before heat storage, and the pH value and emulsion stability should still meet the requirements of this document. --- **Explanation:** - Technical terms like "Ivermectin" and "emulsion stability" are translated according to their standard meanings in the pharmaceutical industry. - Numbers and units (e.g., %, g/L) are retained in their original form. - Specifications like "pH value" and "foaming volume" are translated to match common scientific terminology. - Phrases like "no oil floating" and "precipitation" are rendered to emphasize the absence of undesirable substances in the product. - The requirements for heat and cold storage stability are translated to emphasize the product's resistance to temperature changes. - The final sentence ensures that all technical specifications meet the document's requirements.

Development Information

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