
Automated Sample Preparation System for Content Uniformity Testing
含量均匀度自动样品前处理系统
- CE (to be confirmed)
- +2
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片剂粉碎与提取系统
Price on request — FOB / CIF quoted per order
Prices depend on configuration, quantity and destination port.
| Tablets per batch | 1–10 |
|---|---|
| Particle size | typically below 1 mm |
| Milling time | programmable, 5–120 s |
| Extraction volume | 25–1000 mL |
| Agitation speed | 50–300 rpm |
| Contact material | Stainless steel or polymer |
By Lab Manufacturers China Technical TeamLast reviewed Standards: USP <905>, USP <711>, USP <1092>
A tablet comminution and extraction system crushes or mills tablets and extracts the drug into solution reproducibly. It is chosen when uniform particle size and complete extraction are needed before assay or content testing.
A tablet comminution and extraction system crushes or mills tablets and extracts the drug into solution reproducibly. It is chosen when uniform particle size and complete extraction are needed before assay or content testing.
Complete extraction of a drug from a tablet depends on how finely and uniformly the tablet is comminuted. A comminution and extraction system crushes, mills or grinds the unit, often with a defined particle size outcome, then transfers the powder quantitatively into a flask or vessel for extraction under controlled solvent, volume, agitation and time. Some systems combine comminution with the extraction step in the same vessel to avoid transfer losses, which is valuable for low-dose products where every particle matters. Grinding heat can degrade thermolabile drugs, so milling time and speed must be controlled. Materials contacting the sample must be inert and easy to clean, and cross-contamination between samples is a key risk. Recovery and particle size distribution should be verified during validation.
Sample preparation applies mechanical and chemical steps to make a sample representative and measurable. Tablets are weighed, comminuted by crushing, milling or grinding, and then dissolved or extracted in a volumetric flask or a closed vessel with a defined solvent and time. Powders are sampled with a thief or a spinning riffler so the aliquot reflects the whole blend. Dilution is performed by hand with volumetric glassware or automatically with syringes and valves, and solutions are filtered through membranes to protect the analytical column or detector. Solid-phase extraction concentrates or cleans up analytes before chromatography. Accuracy, completeness of extraction and freedom from contamination determine whether the analytical result is valid.
A typical tablet comminution and extraction system configuration offers tablets per batch of 1–10, particle size of typically below 1 mm, milling time of programmable, 5–120 s, extraction volume of 25–1000 mL, agitation speed of 50–300 rpm and contact material of Stainless steel or polymer. Values are indicative of the product class; the exact figures for each configuration are confirmed on the quotation and the calibration documents supplied with the instrument.
The Tablet Comminution and Extraction System is used in tablet assay sample preparation, content uniformity preparation, modified-release dosage form extraction and low-dose product testing. Across the wider Sample Preparation class, laboratories also deploy it for content uniformity sample preparation, assay sample preparation and dissolution sample handling.
Relevant standards and methods include USP <905>, USP <711>, USP <1092>, ICH Q2(R2), IEC 61010-1 and ISO 17025. Certification candidates for this model are CE, IEC 61010-1 compliance and ISO 13485 manufacturing; each is to be confirmed for the specific configuration before shipment, and certificates are supplied only where they have been issued.
Place equipment on a level, vibration-free bench and keep the area clean, because dust from powders can contaminate open vessels. Verify balances and pipettes at defined intervals and use certified reference weights. Confirm that extraction time and technique are reproducible, since incomplete extraction gives low assay results. Check solvent compatibility of seals, tubing and filters, and change membranes and SPE cartridges according to the method. Avoid cross-contamination by using disposable labware or validated wash cycles, and record reagent lots, sample weights and preparation conditions. Follow local rules for solvent handling and waste disposal.
Specify a comminution and extraction system when uniform particle size and complete recovery are critical, especially for low-dose or modified-release tablets. Confirm achievable particle size, transfer losses, milling heat control and cleaning between samples. Validate recovery against an independently prepared reference.
Select sample preparation equipment from the analytical method and the dosage form. Content uniformity and assay of tablets need precise weighing, complete comminution and accurate dilution. Dissolution studies need large numbers of filtered aliquots taken at timed intervals. Powders and blends need representative sampling rather than grinding. Solid-phase extraction suits trace analysis and complex matrices. Compare the number of samples per run, dilution ratios achievable, weighing accuracy, solvent compatibility, filtration type and carryover control. Automated platforms that combine weighing, dilution and filtration reduce labour and improve data integrity, and their software should support method storage, audit trails and export to a laboratory information management system.
| Tablets per batch | 1–10 |
|---|---|
| Particle size | typically below 1 mm |
| Milling time | programmable, 5–120 s |
| Extraction volume | 25–1000 mL |
| Agitation speed | 50–300 rpm |
| Contact material | Stainless steel or polymer |
| Cleaning | Removable parts or wash cycle |
| Power supply | 220 V, 50 Hz, about 0.3 kW |
Indicative values for this product class. Final specifications are confirmed on the quotation and in the calibration documents supplied with the instrument.
Smaller particles have a larger surface area, so the solvent reaches the drug faster and extraction is more complete in a given time. Particle size that varies between samples causes variable recovery and therefore variable assay results.
Yes. Friction generates heat, and thermolabile or polymorphic drugs can degrade or change form during prolonged or aggressive milling. Milling time and speed should be controlled and validated, and the extract checked for degradation products.
By using removable, cleanable contact parts, running a validated wash cycle, or using disposable grinding vessels or liners. Residual powder from a high-potency product is a particular concern, and cleaning should be verified with swab or rinse samples.
Because an analytical method can only be as good as the sample presented to it. Incomplete extraction, inaccurate weighing, non-representative sampling or contamination all produce results that are wrong even when the instrument performs perfectly.
Individual units are weighed, comminuted, transferred quantitatively to a volumetric flask and extracted with a defined solvent and time. The solution is filtered and measured, and the result for each unit is compared with the monograph acceptance criteria.
For trace analysis, complex matrices or analytes that need concentration before chromatography. The cartridge retains the analyte while interfering substances pass through, then the analyte is eluted in a small volume of solvent, which increases sensitivity and protects the column.

含量均匀度自动样品前处理系统

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