FAQ

Ordering from foreign users and Oversea Shipment

How can we obtain a JP Reference Standard?

General tests, Processes and apparatus, 9.01 Reference standards (1)

The JP Reference Standards listed in JP, General tests, Processes and apparatus, 9.01 Reference standards (1), are produced and distributed by PMRJ. For ordering them, please place your order from the PMRJ Reference Standards Online Store.

General tests, Processes and apparatus, 9.01 Reference standards (2)

The JP Reference Standards, listed in Japanese Pharmacopoeia, General tests, Processes and apparatus, 9.01 Reference standards (2), are produced and distributed by the National Institute of Infectious Diseases (NIID).

How long will it take to receive our order for the JP Reference Standards?

PMRJ will send you our Proforma Invoice or Invoice by email after receiving your order. Then, please make full payment in Japanese Yen in advance by wire transfer, as notified on the Invoice. PMRJ will ship the reference standard(s) via air courier (usually by FedEx) within three business days after your payment is confirmed.
If the remittance is not made in full within 45 days from the date of the Invoice, your order is cancelled automatically.

How much is the shipment charge for overseas?

Charges are 20000 Japanese Yen per shipment that include handling, shipping and packing fee.

How do we know the reference standard availability for overseas shipping?

Some of the reference standards which are restricted legally or require cold shipments are not shipped overseas. You can check availability of the reference standards on our website or current catalog.

Can we choose own carrier?

PMRJ accepts your own carrier by giving us your account number, but 9000 Japanese Yen of handling and packing charges is applied.

Questions and Answers on Storage of JP and Other Compendial Reference Standards

Do the JP and other compendial reference standards have expiration dates?

The reference standards produced and distributed by PMRJ do not have expiration dates. Order only quantities that can be used immediately. After receipt of a reference standard, immediately store it at the specified temperature and use it as soon as possible. Please be aware that the quality of a reference standard cannot be guaranteed if (1) significant time has passed since it was shipped, even if it has not been opened, or (2) it has been stored for a significant period after opening.

How should I store JP and other compendial reference standards?

The storage temperatures are defined as follows
Room Temperature 1 – 30°C
≤25°C 1 – 25°C
Refrigerate (≤8°C) 1 – 8°C
Freeze (≤−20°C) ≤−20°C
Freeze (−20 to −30°C) ≤−20°C. Avoid storage below −30°C because the container may not withstand such low temperatures.
Freeze (−80°C) −80°C ± 10°C

Questions and Answers on Use of JP and Other Compendial Reference Standards

How can I obtain the leaflet for a reference standard?

Are the leaflets for previously purchased reference standards available on the website?

What is the control number shown on the label?

The control number is a product control number used by PMRJ. The control number is different from the lot number.

Can you tell me about the loss on drying or water content value of JP and other compendial reference standards?

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 specified in a calculation formula to determine an assay value in a test method specified in an official compendium, the analyst should 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.
However, 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.

Can you tell me about the purity of the reference standards?

The purity of the reference standards is evaluated by the mass balance method, etc., but is not disclosed.

How is the purity of reference standard (RS) calculated by the mass balance method?

Generally, mass balance purity is calculated by deducting the measured levels of impurities (including residue on ignition, residual solvents, water content, and related substances) from 100.0% (Formula A).

Formula A: Purity (as is)
= 100% − (residue on ignition % + residual solvents % + water content % + related substances %)

However, when the related substances % has been determined by chromatography rather than being based on mass fraction, purity is calculated using Formula B.

Formula B: Purity (as is)
= {100% − (residue on ignition % + residual solvents % + water content %)} × (100% − related substances %) / 100

However, for JPRSs, when JP Monograph quantitative tests that use the JPRS contain directions to dry the RS or to convert the RS value by calculating on the dried basis, calculating on the anhydrous basis, or calculating on the anhydrous and residual solvent–free basis, purity is determined by subtracting the measured impurities from 100.0% after drying the RS or performing the specified conversion. For example, after calculating the RS value on the anhydrous basis, purity is calculated using Formula C.

Formula C: Purity (anhydrous substance)
= {100% − (residue on ignition % + residual solvents %)} × (100% − related substances %) / 100

The impurities that are subtracted differ depending upon the specificity of JP Official Monograph quantitative tests that use the RS. For example, in RSs used in assays performed by ultraviolet-visible spectrophotometry, substances having the same absorption as the main component at the specified wavelength are not regarded as impurities. Likewise, in RSs used in assays performed under conditions that cannot separate optical isomers, optical isomers are not regarded as impurities.

What are the correction factors in the leaflets for some reference standards?

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., and shown as a correction factor. In determining whether to provide such correction factors, the test methods in which the reference standards are used are taken into consideration. When a correction factor is provided in the Correction Information section of a leaflet, the quantitative tests in which the correction factor is to be used are indicated following the correction factor. When the reference standard is used in any of those quantitative tests, the weighed amount of reference standard must be corrected by the correction factor. Different lots of the same reference standard can have different correction factors, so please be sure to check the leaflet for the reference standard lot that will be used.

Under what circumstances are correction factors provided?

For reference standards used in quantitative tests, a correction factor with 3 significant figures is provided when purity, considering the test method in which the reference standard is used (see A9), is <99.5% and the content specification in the JP Monograph is given to 3 significant figures. Likewise, for reference standards to be used for crude drug Monographs etc., a correction factor with 2 significant figures is provided when purity, considering the test method in which the reference standard is used, is <99.0% and the content specification in the JP Official Monograph is given to 2 significant figures. However, once a correction factor has been provided for a reference standard, a correction factor will continue to be provided for that reference standard even if the purity of subsequent lots improves to ≥99.5% or 99.0%, respectively. Consequently, there are reference standards whose purity is shown as ≥99.5% (e.g., correction factor: 0.997). Furthermore, correction factors are provided for all reference standards newly established in JP17 Supplement I and thereafter that are used in quantitative tests.

Why does PMRJ continue to provide a correction factor for a reference standard regardless of purity once a correction factor has been provided?

Let’s consider the example of a reference standard whose purity improves from 99.4% (correction factor of 0.994 provided) to 99.6%. If a correction factor were no longer provided after the improvement in purity, the reference standard would be regarded as 100.0% when it was used. Consequently, the real difference in purity of 0.2% would increase to an apparent difference of 0.6%. To avoid situations like this, once a correction factor has been provided for a reference standard, a correction factor will continue to be provided for that reference standard regardless of its purity. In the above example, a correction factor of 0.996 will be provided for such reference standard.

How should I use correction factors?

If a correction factor is provided in the Correction Information section of the leaflet for a 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.

 

Example: Excerpt from Japanese Pharmacopoeia Epitiostanol Reference Standard leaflet

《Intended Uses》
• JP Mepitiostane: Assay (LC)

《Correction Information》
Water content: 1.5%
Correction factor: 0.990 (Assay (LC), on the anhydrous basis)
(The subsequent text in the leaflet has been omitted.)

One intended use of the JP Epitiostanol Reference Standard is the JP mepitiostane assay by liquid chromatography, which is a quantitative test. When the Epitiostanol Reference Standard is used in that assay, the directions in JP are to be followed and the amount of reference standard is to be multiplied by the correction factor, 0.990.

Mepitiostane Assay instructions in JP (excerpted)

Amount (mg) of mepitiostane (C25H40O2S)
= MS × (QT /QS) × 5 × 1.320
MS: Amount (mg) of Epitiostanol RS taken, calculated on the anhydrous basis

Correction method: The correction factor, 0.990, indicates the purity of anhydrous Epitiostanol Reference Standard. Therefore, first calculate the amount (mg) of Epitiostanol Reference Standard on the anhydrous basis by using the water content value of 1.5% given in the Correction Information section of the leaflet. Then, multiply that amount by the correction factor 0.990, and use the result as the MS value in the calculation formula. Inclusion of the above-mentioned steps in the JP calculation formula results in the following formula:

Amount (mg) of mepitiostane (C25H40O2S)
= Amount of reference standard actually weighed (mg) × 0.985 × 0.990 × (QT / QS) × 5 × 1.320

The leaflet specifies the quantitative tests in which the correction factor is to be used. Can the correction factor be used in quantitative tests that are not specified in the leaflet?

As explained in A10, correction factors are established based on purity, considering the test methods in which the reference standards are specified to be used. For this reason, correction factors must not be used in tests other than those specified in the leaflet. For example, a correction factor that is used in an assay by liquid chromatography cannot be used in an assay by ultraviolet-visible spectrophotometry.

Questions and Answers on Quality Assurance for JP and Other Compendial Reference Standards

To what extent is the quality of the reference standards assured?

The reference standards distributed by PMRJ are assured to be suitable for the tests in the official compendia in which their use is specified. The specified intended uses of each reference standard are given in the Intended Uses section of its leaflet. The quality of the reference standard cannot be assured if it is used in tests other than those specified in the leaflet.

When performing tests specified in JP, can I use reference standards other than JP reference standards, e.g., USP or EP reference standards?

When a bioassay test method based on a JP reference standard is specified in an official monograph in JP, can that reference standard also be used as a reference standard in other test methods not present in the official monographs in JP, e.g., assay by HPLC?

JP reference standards have been established for use in tests specified in JP; their quality is assured only for those intended uses. The intended uses specified in JP are given in the leaflet for each reference standard. Please be aware that the quality of reference standards distributed by PMRJ cannot be assured if they are used in applications not specified in their leaflets.

What are the basic policies for establishing JP reference standards, and how is the quality of JP reference standards evaluated?

The basic policies for establishing JP reference standards and the parameters for evaluating their quality are given in “Reference Standards and Reference Materials Specified in the Japanese Pharmacopoeia” in the “General Information” section of JP. Please refer to that.

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