Zimeng-Application of Multi functional Particle Size Analyzer ZML310 for API Particle Size Detection in Tablets Polycarbonate Calcium Tablets

As a commonly used formulation for the treatment of digestive diseases such as constipation, the particle size of the active pharmaceutical ingredient (API), Polycarbonate Calcium, directly determines the bioavailability, tablet compression process stability, and clinical efficacy of the formulation. Uneven API particle size may lead to delayed tablet disintegration, fluctuations in efficacy, and even problems such as sticking and cracking during production. Zimeng Technology ZML310 Multi functional Particle Size Analyzer relies onHigh precision detection+compliant design+scenario adaptationOur core advantage is to become a key equipment for quality control of the entire particle size process of Polycarbonate Calcium API.

1、 Core of Particle Size Detection for Polycarbonate Calcium APIdemand

Under the GMP standards in the pharmaceutical industry, the particle size detection of Polycarbonate Calcium API needs to meet three core requirements:

1. Accurate coverage of API particle size range:After crushing and granulation, the particle size of Polycarbonate Calcium API is usually concentrated in the range of 0.2-100 μ m, which requires precise instrument captureD10、D50、D90Wait for key indicators to avoid the impact of too coarse particles on disintegration speed, or too fine particles causing poor fluidity and uneven content.

2. Eliminate interference to ensure data reliability:API powder is prone to problems such as particle adhesion and the mixing of trace impurities, and the instrument needs to be equipped withBackground noise reduction and particle recognition capabilityTo avoid false positive data affecting quality judgment.

Compliance and Traceability: The testing process must support SOP file association, testing personnel permission management, tamper proof data, and high confidence in the results to meet the requirements of drug registration verification and inter batch quality comparison.

2、 Technical advantages of ZML310 in adapting to the detection of Polycarbonate Calcium API

1. Wide range high-precision detection, locking key particle size parameters of API

The analysis range of ZML310 covers 0.2-3000.0 μ m, fully matching the particle size range of Polycarbonate Non Calcium API, which can clearly identify small particles and ensure the detection accuracy of D10, D50, D90 and other indicatorsTo provide reliable data support for the correlation analysis between API particle size and key quality attributes such as tablet disintegration time and hardness in the formulation processMore in line with the requirements of formulation performance evaluation.

2. Anti interference design to solve API adhesion and impurity problems

ZML310 has two core functions in response to the adhesive properties of Polycarbonate Non Calcium API:

One is supportBackground Modeadjust+BrightnesspatternAdjustment "It can effectively highlight the contour of API particles and reduce the interference caused by the reflection of auxiliary materials；

Secondly, it is built-inAdhesion analysisFunction: It can visually distinguish independent particles from adhesive particles through the two-dimensional distribution of horizontal and vertical coordinates, avoiding misjudging adhesive particles as large particle size particles and ensuring the authenticity of detection data.

API

3. High confidence and compliance, meeting the quality control requirements of the pharmaceutical industry

Multi functional particle size analyzerSupport direct association of SOP files, automatic retention of testing personnel operation records and testing time (accurate to seconds), meeting the requirements of drug GMPData traceability and process reproducibilityThe requirements，Facilitate batch comparison and registration data archiving by the quality department.

3、 The Application Value of ZML310 in the Whole Process Quality Control of Polycarbonate Calcium API

1. R&D stage: Optimize API pre-processing workart

In the early stage of the development of Polycarbonate Calcium Tablets, the particle size distribution of API under different grinding parameters (such as grinding time and speed) can be compared using ZML310. For example, the grinding process with D50 between 41-45 μ m and D90 ≤ 75 μ m can be screened to ensure that the API can meet the flowability of tablet pressing and ensure that the subsequent dissolution rate meets the standard; At the same time, the roundness and sphericity of the API can be analyzed synchronously to assist in determining whether the particle flowability is suitable for the filling requirements of the high-speed tablet press.

2. Production stage: Real time monitoring of API quality stability

During the production process, before each batch of Polycarbonate Calcium API is stored, it can be quickly tested by ZML310 (with a single testing time of less than 5 minutes). If D90 exceeds 75 μ m, it can be promptly reported to the upstream supplier or the granulation process can be adjusted to avoid unqualified API flowing into the tablet pressing process; At the same time, conducting API particle size sampling on intermediate products (such as granules after granulation) can monitor whether the granulation process leads to excessive aggregation of API particles, ensuring that the uniformity of tablet content meets pharmacopoeia requirements.

3. Quality control stage: inter batch consistency verification

Before the release of finished products, ZML310 can be used to randomly inspect the particle size of API in Polycarbonate Calcium Tablets, compare the D50 and D90 deviations of different batches, and if the deviation is ≤ 5%, it is judged as stable quality; If there is a significant deviation, it can be traced back to API raw materials or granulation processes to quickly identify the root cause of the problem and reduce quality risks.

Zimeng Technology ZML310 Multi functional Particle Size AnalyzerAccurate detection+anti-interference+complianceOur core capability accurately solves the key pain points in particle size detection of Polycarbonate Calcium API, achieving full process particle size quality control from raw material storage to finished product release, helping pharmaceutical companies improve product quality stability and reduce clinical medication risks.