Observation of differences in apparent structure and particle size distribution after processing

Dry testing of Zimeng Multi functional Particle Size Analyzer ZML320 in APIadvantage

In the research and quality control of raw material drug production, particle size distribution and particle shape characteristics are the core indicators that determine drug dissolution rate, bioavailability, and production process stability. Laser particle size analyzer, as a traditional detection equipment, has long been plagued by inherent defects in dry testing of raw materials:

1. High pressure airflow dispersion or mechanical stirring can easily lead to the breakage of fragile raw material particles, resulting in“Pseudo fine particles”；

2. Can only provide particle size data, unable to accurately characterize particle shape parameters;

3. Sample aggregation is difficult to effectively crack, and test results deviate from the true state;

4. The operation process is complex and prone to human error, making it difficult to meet the requirements of standardized quality control.

Shanghai Zimeng Technology deeply cultivates grainsdegreeIn the field of analysis, the ZML320 multifunctional particle size analyzer has been launched, relying on visualization technology and innovative dispersion solutions to tackle the core pain points of laser particle size analyzers, providing a solution for dry testing of raw materials“Non destructive, precise, efficient, and comprehensive”The integrated solution, with its technological advantages and application value deeply in line with industry needs.

1 Gentle dispersion+non-destructive protection, restoring the true state of fragile particles

Raw materials (especially crystalline APIs, traditional Chinese medicine powders, etc.) are commonly presentThe characteristics of low mechanical strength and easy breakageThe Laser Particle Size AnalyzerHigh pressure airflow dispersion technologyIt will cause severe impact on particles,Destroy the original structure of particlesThis leads to distorted test results and cannot provide reliable data for process optimization.Zimeng TechnologyInnovative combination with ZMD800 vacuum powder disperser, using the principle of vacuum suction and negative pressure adsorption to achieve uniform powder dispersion, fundamentally avoiding mechanical damage to fragile particles caused by high-pressure airflow.

The ZMD800 vacuum powder disperser can achieve a maximum pressure of 100Psi and a dispersion diameter of 10cm. It can evenly spread the raw material powder on glass slides under mild conditions, solving the problem of particle aggregation caused by traditional spoon shaking, ensuring that a large number of individual particles are fully exposed, and guaranteeing the scientificity of statistical results.

Meanwhile, the decentralized planNo need to add dispersantsAvoiding contamination of samples by chemical reagents, especially suitable forEasy to oxidize and absorb moistureSensitive raw materials. Paired with the precise detection system of ZML320, even typical fragile raw materials such as ibuprofen and vitamins can accurately reproduce their true particle size distribution.

II Multidimensional representation+efficientIdentify and achieve precise analysis of particle size and shape synchronization

Laser Particle Size AnalyzerBased on the principle of laser diffraction, only throughIndirect calculation to obtain particle size data，Unable to capture particle shape informationThe particle shape parameters (such as roundness, sphericity, aspect ratio) directly affect the flowability, mixing uniformity, and compression molding effect of the raw material drug. ZML320 is equipped with a 20 megapixel high-definition color camera and a professional image analysis system, which can be synchronously completed in dry testing modeMultidimensional characterization of particle size and shapeFill in the technical gap of traditional equipment.

Based on the characteristics of active pharmaceutical ingredients, ZML320 can accurately calculate multiple key parameters such as equivalent area circle, equivalent length diameter, roundness, etc,Particle recognition accuracy up to 99%AboveThe confidence level can reach 99%99%Provide comprehensive data support for optimizing the crystallization process of active pharmaceutical ingredients and adapting formulation formulas. Its detection range covers 200nm-3000 μ m and can be adapted to various applicationsVarious raw materials from ultrafine powder to coarse particlesTest requirements and fully comply with them《Pharmacopoeia of the People's Republic of ChinaHow to translate

CP0982 Law 1 Standard requirements.

IIIIntelligent anti-interference+precise aggregation breaking, overcoming complex sample testing challengesRaw material powder is prone toIntermolecular forcesAgglomeration occurs due to electrostatic interactionsLaser particle size analyzer is difficult to distinguish between real agglomerates and single particles, often mistaking agglomerates as large particles, resulting in test result deviation. ZML320 relies on multiple

1. Specially availableTechnology effectively solves pain points in this industry:Equipped with multi background mode switching function, the optimal background can be selected based on the color characteristics of the active pharmaceutical ingredient, accurately distinguishing between them

2. Particles and impurities, aggregates and single particles；ZMD800 TrueAir dispersion technology can be effective

3. divideDisperse loose aggregates while preserving the true binding state between particles, ensuring that the test results reflect the actual characteristics of the active pharmaceutical ingredient.For raw materials such as traditional Chinese medicine powders with complex components and uneven colors, ZML320's high-definition imaging system and

Powerful system functions It can accurately identify target particles, avoid the influence of color absorption on detection results, and control the dispersion coefficient of test data within a reasonable range, fully ensuring the accuracy and reliability of complex sample analysis.

4Standardized process+efficient operation, in line with the scale requirements of quality controlLaser particle size analyzer dry testing requires

After weighing, dispersing agent preparation, and pressure adjustmentThe complex pre-processing process is cumbersome and time-consuming, and human differences in operation can easily lead to poor repeatability of test results, making it difficult to meet the quality control requirements of large-scale production of active pharmaceutical ingredients.ZML320 adheres to

1. Convenience and standardization

2. Design concept, greatly simplifying the testing process:Sample pretreatment only requires a small amount of use, and standardized sample preparation is achieved through the ZMD800 vacuum disperser, without the need for complex mixing;Support during testing process

Automatic photography, automatic particle recognition, automatic statistical analysisThe testing cycle for a single sample can be shortened to a few minutes, and the total number of particles can easily reach thousands, ensuring the representativeness of the statistical results.device software

Capable of user management, audit tracking, and data backupThe functionality meets GMP compliance requirements and enables full traceability of the testing process; Support batch particle labeling, multi-dimensional report output, and provide key particle size parameters such as D3, D10, D50, D90, D100, as well as the percentage content of each particle size range, to meet the diverse data needs of the quality control department.In addition,

真空粉末 The disperser has a compact size (controller length 270mm x width 220mm x height 120mm), occupies a small space, and is suitable for various layout scenarios in the laboratory.

5Compliance certification+wide application, forging industry trust

ZML320 strictly follows the relevant standards of the Chinese Pharmacopoeia and has passed ISO system certification. Its test results have been recognized by the National Medical Products Administration and multiple drug testing institutes. At present, it has been successfully applied in the research and quality control of multiple approved raw material varieties such as Cleboride Ointment, Fluticasone Propionate Cream, and Leuprorelin Acetate

.Whether it's optimizing the crystallization process of API raw materials, quality control of traditional Chinese medicine powders, or batch consistency testing in large-scale production, ZML320 can provide a testing experience beyond traditional laser particle size analyzers with its core advantages of "non-destructive dispersion, multidimensional characterization, intelligent precision, and standard efficiency".The core demand for dry testing of active pharmaceutical ingredients lies inRealistic reflection of sample characteristics, accurate provision of comprehensive data, efficient adaptation to quality control processesZML320 multifunctional particle size analyzer