How to choose a disintegration tester
Huanghai Pharmaceutical Instruments (Shanghai, since 1978) makes two disintegration testers for USP <701>, ChP 0921 and Ph. Eur. 2.9.1: the 2-station LB-2D and the 3-station LB-3D. Both use 6-tube basket-rack assemblies with a 55 ± 1 mm stroke and 20–45 °C temperature control (±0.3 °C). The choice is mainly throughput and data: LB-3D adds a third station, up to 100 timed checkpoints, user management and an audit trail.
Model comparison
| Model | Stations | Stroke rate | Checkpoints | Data and access control |
|---|---|---|---|---|
| LB-2D | 2 | 30–32 strokes/min | Up to 15 preset reminders | RS232 printer, USB TXT export |
| LB-3D | 3 | 25–35 strokes/min | Up to 100 timed points | 3-level users, audit trail, USB, RS232 |
| SY-6DN | 1 (6 tubes) | 30–32 strokes/min | — | 3-level users, audit trail (4-in-1 system) |
How to choose
- USP <701> moves the basket-rack 29–32 cycles per minute through 53–57 mm in immersion fluid at 37 ± 2 °C; both LB models meet this window.
- Regulated QC with data-integrity requirements: LB-3D has 3-level user management and an audit trail. LB-2D has printer and USB output without user login.
- More products per day or longer test windows: LB-3D runs three baskets and up to 100 timed checkpoints.
- The disintegration end point is judged visually by the operator at each checkpoint, as the pharmacopoeia requires; the instruments alert you at each preset time.
Pharmacopoeia and compliance
USP <701>, ChP 0921, Ph. Eur. 2.9.1 / BP Appendix XII A1. The basket-rack assembly, tube and mesh geometry, discs and stroke follow the harmonised apparatus. IQ/OQ documentation templates are supplied with each instrument.
Frequently asked questions
What is the difference between disintegration and dissolution testing?
Disintegration checks how quickly a tablet or capsule breaks up in fluid; dissolution measures how much drug goes into solution over time. Disintegration is a quick physical test; dissolution is the release test used for most specifications.
What are the USP <701> apparatus settings?
29–32 cycles per minute, 53–57 mm stroke, immersion fluid at 37 ± 2 °C, 6 units per basket.
LB-2D or LB-3D?
LB-2D suits routine testing of up to two samples at a time. LB-3D adds a third station, up to 100 timed checkpoints, user management and an audit trail for regulated QC.
Is the end point detected automatically?
No. As the pharmacopoeia requires, the operator judges complete disintegration visually; the tester signals each preset checkpoint.
Related guides: LB-2D vs LB-3D selection guide · Disintegration vs dissolution testing