Instructions for Use
Instructions for Use
Precautions
- All the reference standards distributed by PMRJ are analytical reagents. They are not drugs or clinical diagnostic drugs, so they must not be used in humans or animals.
- The reference standards distributed by PMRJ are guaranteed to be suitable for uses specified in the official compendia. The specified uses are given in the Intended Uses section of the leaflet for each reference standard. Please be aware that the quality of the reference standards is not guaranteed if they are used in tests other than those in which their use is specified.
- Order only quantities that can be used immediately. After receipt of the reference standards, immediately store each reference standard according to its exterior label and the Storage Conditions section of its leaflet and use it. The quality of a reference standard cannot be guaranteed if it has been stored after opening.
- The Safety Data Sheet (SDS) for each reference standard can be accessed from the reference standard’s webpage.
- Test data of the reference standards are not disclosed, and certificates of analysis for the reference standards are not issued.
Weighing
- If the official compendium instructs that the reference standard should be dried, please dry the appropriate amount of the standard in accordance with the compendium before use. Some reference standards are hygroscopic after drying, so weigh them as quickly as possible.
- If the《Unit Quantity》section of the leaflet instructs in to reconstitute the entire contents, do not weigh it.
Correction Information
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Loss on Drying and Water Content
- When “amount (mg) of ABC reference standard taken, calculated on the dried basis” or “amount (mg) of XYZ reference standard taken, calculated on the anhydrous basis” is prescribed in a calculation formula in a test method specified in an official compendium such as JP, please determine the loss on drying or water content of the reference standard, and calculate the amount of reference standard taken on the dried or anhydrous basis.
- If the Correction Information section of the reference standard leaflet contains a loss on drying or water content value, the amount taken may be converted to the amount calculated on the dried or anhydrous basis by using the value given in the leaflet.
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Correction Information
- When some reference standards are to be used in quantitative tests specified in official compendia, their purity is calculated by the mass balance method, etc.. If a correction factor is provided in the Correction Information section of the leaflet for the reference standard, correct the weighed amount of reference standard by multiplying it by the correction factor when the reference standard is used in the quantitative tests specified following the correction factor.
- If a correction factor is not provided, the reference standard is regarded as being 100.0%, and there is no need to correct the weighed amount.
- When the quantitative tests contain directions to convert the reference standard value by calculating on the dried basis, calculating on the anhydrous basis, or calculating on the anhydrous and residual solvent–free basis, apply the correction factor after performing the specified conversion.
Storage Temperatures
After receipt of a reference standard, immediately store it at the specified temperature and use it as soon as possible. The storage temperature of each reference standard is noted in the Storage Conditions section of its leaflet and on the exterior label.
| Designated temperature | Temperature range |
|---|---|
| Room Temperature | 1 - 30℃ |
| ≤25℃ | 1 - 25℃ |
| Refrigerate（≤8℃） | 1 - 8℃ |
| Freeze（≤-20℃） | ≤-20℃ |
| Freeze（-20 - -30℃） | ≤-20℃. Avoid storage below -30℃ because the container may not withstand such low temperatures. |
| Freeze（≤-80℃） | -80±10℃ |
Shipping Conditions
The shipping conditions when products are dispatched from PMRJ are shown on the webpage for each reference standard in the online store. In some cases, the temperature range specified for shipping differs from the storage temperature. These conditions are determined based on the results of stability tests.
Valid Use Date
The valid use date assigned for the reference standards distributed by PMRJ is one year from the end of distributing a lot (excluding items specified separately). Once the distribution of the lot ends immediately after your purchase, one year, which is the shortest term, is assigned as the valid use date from the shipping date of the items you purchase. Please order only the required amount of the reference standards that can be used immediately and store the reference standards under the specified conditions after their receipt. Please use the reference standards as soon as possible even if it is still within the valid use date.
The current lot number being distributed can be found on the webpage for each reference standard in the online store. Once the distribution of a lot ends, the valid use date for the lot can be found on the webpage in the online store. For items specified separately, the details can be found on the webpage for each reference standard.
Contact Us
If you have any questions or require further information, please contact us using the “Contact form”.
Frequently Asked Questions
Please also check the “Frequently Asked Questions” on the online store.