Zimeng-Multi functional particle size analyzerProgesterone sustained-release gelinGranularity testingapplication

As a commonly used preparation in gynecology, the particle size and morphology of progesterone sustained-release gel directly affect the drug release rate, mucosal absorption efficiency and clinical efficacy - uneven particle size distribution may lead to fluctuations in the sustained-release effect, and non spherical or agglomerated particles may easily cause local irritation. Shanghai Zimeng Technology ZML320 multi-function particle size analyzer, combined with the requirements of the method CP0982 in the Chinese Pharmacopoeia, completed the preparation of progesterone sustained-release gelAccurate particle size and morphology characterizationProvide comprehensive data support for formulation research and quality control.

1 Testing Fundamentals:Multi functional particle size analyzerAdvantages and Testing Methods

1. CoreadvantageZML320 Multi functional Particle Size Analyzer

Zimeng ZML320 equipment, specially designed for semi-solid preparations (gel, ointment, etc.), meets the test requirements of progesterone sustained-release gel:

a. Full coverage of detection capability:The detection range is 0.2 μ m~3000 μ m, accurately capturing particles in different particle size ranges in gel, matching the particle size distribution characteristics of progesterone;

b. Multi parameter synchronous representation:Synchronize measurement of particle size and morphology parameters without the need for additional equipment assistanceBy synchronously obtaining over 20 morphological parameters such as equivalent diameter and roundness of progesterone particles without switching detection modules, the morphological characteristics of progesterone particles can be visually presentedparticle sizeRealize comprehensive characterization of the microstructure of the formulation in terms of both shape and morphology;

c. High reliability guarantee:Using standard particlesconductCalibration, accuracy error<3%, repeatability RSD<3%, confidence level up to 98.80%, in line with the quality control requirements of the pharmaceutical industry;

d. Standardization of sample preparation:Paired with Zimeng semi-solid-The standard sample preparator ZMD-801 presses the gel sample into uniform flakes with adjustable thickness to solve the industrial pain points of uneven thickness and particle agglomeration of manual sample preparation and ensure the repeatability of the test.

II Test results and in-depth interpretation: dual quality control of particle size and morphology

1. Granularity core data: evenly distributed and meets the requirements of the formulation

The particle size data of progesterone sustained-release gel output by ZML320 fully coversCharacteristic particle size, average particle size, and segmented proportionAccurately reflecting the characteristics of particle populations:

2. Key morphological parameters: regular particle morphology without obvious agglomeration

The unique advantage of ZML320 is that it can synchronously obtain the morphological parameters and crack the real state of particles that can not be reflected by the simple particle size data, which is crucial to the quality control of progesterone gel:

a. Sphericity and roundness:The average sphericity is 0.814 and the average roundness is 0.900, indicating that the particle shape is close to spherical and there are no obvious irregular shapes such as needle like or flake like shapes. Regular shapes can reduce mucosal friction and improve medication comfort;

b. Length to diameter ratio and aspect ratio:The average aspect ratio is 1.571, the average aspect ratio is 1.495, and the maximum aspect ratio is 4.707 (extremely low proportion). The overall particle has no excessive elongation phenomenon, avoiding uneven release rate caused by irregular morphology；

c. Reunion status:Through the high-definition imaging and particle recognition function of the equipment (recognition>98%), no obvious aggregates were observed, only a single particle existed independently, indicating that the gel matrix dispersion system was stable and there was no risk of particle aggregation.

d. Test confidence level 98.80%：Combining 6537 statistical particle counts ensures that the data has strong statistical significance and can serve as a reliable basis for R&D comparison and batch production quality control.

3、 Solution to test pain points of progesterone gel

1. Solve the problem of pre-treatment of semi-solid preparations

The progesterone sustained-release gel is a viscous semi-solid,Traditional sample preparation is prone to uneven thickness and particle agglomerationThis leads to testing deviations. The Zimeng ZML320, paired with the semi-solid standard sampler ZMD-801, can accurately adjust the pressing thickness (10 μ m~3mm) and apply stable pressure (<10Kg) to ensure consistent sample preparation conditions and avoid errors caused by pre-processing from the source.

2. Multi parameter synchronous characterization, surpassing simple granularity testing

Conventional laser particle size analyzerOnly able to output equivalent volume diameter, unable to distinguish between particle morphology and agglomeration stateZML320 also providesmanyItem+morphology parameters, as in this testHigh sphericityThe data directly verified the rationality of the dispersion process of gel preparation and provided an intuitive basis for process optimization - if the sphericity is low, it can be improved by adjusting the amount of dispersant or stirring process.

3. Complies with pharmacopoeia standards and supports compliance declaration

The testing method strictly follows the "Chinese Pharmacopoeia 2025 Edition Part Four General Rules 0982 Method", and the equipment has passed ISO system certification and canProvide audit trail, data backup, and permission gradingMeet the compliance declaration requirements of pharmaceutical enterprises with other functions. Previously, Zimeng ZML320 has assisted in the approval of multiple formulations such as Kelibarluo ointment and Dinide cream, and its data reliability has been recognized by multiple leading pharmaceutical companies.

Zimeng ZML320 PassedStandardized sample preparation+precise detection+multi parameter outputThe integrated solution of, not only solved the core pain point of semi-solid preparation particle size test, but also provided traceability and high confidence data support for the research and development iteration of progesterone sustained release gel (such as prescription optimization, process adjustment) and mass production quality control. Zimeng Technology will continue to rely on the technological advantages of ZML320, combined with the needs of the pharmaceutical industry, to providemoreThe product provides more accurate particle characterization services, helping enterprises improve the quality of formulations and accelerate the compliance declaration process.