How to choose a suppository melting time tester
Suppositories are tested for melting (softening) time rather than tablet-style disintegration. The RBY-N from Huanghai Pharmaceutical Instruments (Shanghai, since 1978) is a dedicated suppository instrument: 3 test stations, a 5,000 ml glass beaker, a holder that turns 180° on a programmable 1–30 min cycle, and temperature control to ≤±0.3 °C. It follows the ChP 0922 melting-time method, with an apparatus design equivalent to Ph. Eur. 2.9.2.
Model comparison
| Model | Stations | Cycle | Temperature | Data and access control |
|---|---|---|---|---|
| RBY-N | 3, tested simultaneously | 180° turn every 1–30 min (programmable); test time up to 999 h | Room temperature to 45 °C, 0.1 °C resolution, ≤±0.3 °C | 3-level users, system log (audit trail), USB, RS232 printer |
How to choose
- Suppositories and pessaries need a dedicated melting time tester such as the RBY-N; hardness and disintegration testers are not designed for them.
- Throughput: the 3 stations run simultaneously, matching the three units tested per determination.
- Start of shift: the 24-hour reservation timer heats the water before the operator arrives.
- Regulated QC: user login with three permission levels, a system log of operator, time and action, sample information management and USB export.
Pharmacopoeia and compliance
ChP 0922 (melting time of suppositories and pessaries); apparatus design equivalent to Ph. Eur. 2.9.2 / 2.9.22. USP has no dedicated suppository melting apparatus. IQ/OQ documentation templates are provided.
Frequently asked questions
Why test melting time instead of disintegration for suppositories?
Suppositories release the drug by melting or dissolving at body temperature, so pharmacopoeias test the time to melt, soften or dissolve rather than tablet-style disintegration.
Which pharmacopoeia methods does the RBY-N follow?
ChP 0922. The apparatus design is equivalent to Ph. Eur. 2.9.2 / 2.9.22.
How many suppositories can be tested at once?
Three, one in each station, tested simultaneously.
What temperature range does the RBY-N cover?
Room temperature to 45 °C with 0.1 °C resolution and ≤±0.3 °C accuracy, which covers the 37 °C test condition.
Does the RBY-N have user management?
Yes. It has user login with Admin / Power User / User levels, a system log (operator, date-time, action), data query, USB export and an RS232 printer.
Related guides: Suppository melting time tester buying guide · RBY-N and suppository testing standards · Disintegration testers