Stability News from Japan

The Japanese Society of Hospital Pharmacists has publicized their recommendations / requirements for tablets and capsules stability data on their home page as of April 2025. This information has been in stages of release with related organizations since August 1999.

Their three-part recommendation includes critical measurement items, required storage conditions, and evaluation criteria. In further detail, these are:

1. Measurement items
1. Appearance
2. Content
3. Hardness (for tablets)
4. Disintegration
5. Dissolution
2. Storage conditions
1. Temperature: 40 +/- 2 degrees, 3 months in the bottle
2. Humidity: 75 +/- 5 %RH, 25 +/- 2 degrees, open (no package)
3. Light: 600 thousand Lux Hours, in bottle; radiation standards of D65 or ID65 daylight color of fluorescent lamp, xenon lamp or halogen lamp
3. Evaluation criteria in terms of change
1. Appearance: almost no change
2. Content: less than 3% change
3. Hardness: less than 30% change
4. Disintegration and Dissolution: within relevant specifications

It is interesting to note that in China, test results data access is denied to the performer of the tests and is limited to the laboratory supervisor, group leader and QC Head (If not, this becomes an observation by the authority). Though not precisely stated, re-analysis therefore, can only be performed under the direction of the QC Head.