FAQ

2-A1　The leaflet for each reference standard is available on the webpage for the reference standard of the PMRJ website.

2-A2　The leaflets for the current lots of reference standards are available on the online store. For lots replaced on or after April 1, 2024, the leaflet for the previous lot is also available on the online store. However, leaflets for previous lots depleted by the end of March, 2024 are not available on the online store. If the leaflet for a reference standard that was purchased in the past is not available on the online store, please contact us by using the “Contact Us.”  

2-A3　The control number is a product control number used by PMRJ. The control number is different from the lot number.

2-A4　The certificate of analysis is not provided and also the test results are not disclosed.

2-A5　The quality specifications are not disclosed.

2-A6　Such reference standards have not been dried before shipment. The user should dry, as directed, the proper quantity of reference standard before use.

2-A7　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 to determine an assay value in a test method specified in an official compendium such as JP, 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.

2-A8　The content / potency of the reference standards for quantitative tests is assigned in compliance with intended uses specified in JP and other compendial monographs. In general, the purity (%) based on the mass balance method for chemical reference standards, the potency (μg/mg) of activity for antibiotics reference standards, and the potency (units of biological activity) or the protein content for biological reference standards are assigned. In principle, the collaborative studies for determining the assigned values are conducted by more than three laboratories including PMRJ and external testing laboratories.

2-A9　The purity of the RS is 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%.
When the related substances % has been determined by chromatography rather than being based on mass fraction, purity is calculated using Formula A.

Formula A: 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 B.

Formula B: 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, regarding 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, regarding RSs used in assays performed under conditions that cannot separate optical isomers, optical isomers are not regarded as impurities.

2-A10　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.

Example of correction factors:
  Purity 99.99% →　correction factor: 1.000 (Assay (LC), Uniformity of dosage units (LC))
  Purity 99.75% →　correction factor: 0.998 (Assay (LC), on the anhydrous basis)

As above, 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 and the way of the specified conversion (e.g., on the anhydrous basis) are indicated following the correction factor, that is in parentheses. 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.

2-A11　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 Atorvastatin Calcium Reference Standard leaflet

《Intended Uses》

・JP Atorvastatin Calcium Hydrate: Identification (Ultraviolet-visible Spectrophotometry, Infrared Spectrophotometry) and Assay (LC)

・JP Atorvastatin Calcium Tablets: Uniformity of dosage units (LC), Dissolution (LC) and Assay (LC)

《Correction Information》

Water content: 4.5%

Correction factor: 0.997 (Assay (LC), Uniformity of dosage units (LC), Dissolution (LC), on the anhydrous basis)

For example, when used in Assay (LC) of JP Atorvastatin Calcium Hydrate, the correction is applied as follows. The same correction should be applied when the reference standard is used in other quantitative tests.

Atorvastatin Calcium Hydrate Assay instructions in JP (excerpted)

Amount (mg) of atorvastatin calcium (C₆₆H₆₈CaF₂N₄O₁₀)

= M_S × (Q_T /Q_S)

M_S: Amount (mg) of Atorvastatin Calcium RS taken, calculated on the anhydrous basis

Correction method for using in Assay (LC) specified in JP Atorvastatin Calcium Hydrate:

The correction factor, 0.997, indicates the purity of anhydrous Atorvastatin Calcium Reference Standard. Therefore, first calculate the amount (mg) of Atorvastatin Calcium Reference Standard on the anhydrous basis by using the water content value of 4.5% given in the Correction Information section of the leaflet. Then, multiply that amount by the correction factor 0.997, and use the result as the M_S value in the calculation formula. Inclusion of the above-mentioned steps in the JP calculation formula results in the following formula:

Amount (mg) of atorvastatin calcium (C₆₆H₆₈CaF₂N₄O₁₀)
= Amount of reference standard actually weighed (mg) × (100 – 4.5)/ 100 × 0.997 × (Q_T / Q_S)

2-A12　Basically, when the purity of reference standard is ≥99.5%, its purity had been regarded as 100.0% according to the policy of JP. It is why not many chemical reference standards used in quantitative tests had been provided correction factors in the past. However, by following this policy, reference standards used in quantitative tests cause the error up to 0.5%. Therefore, it was decided that the policy changed to the following; Basically, the chemical reference standards used in quantitative tests are provided correction factors even if their purities are ≥99.5%, and the weighed amount of the reference standards must be corrected by the correction factor when the reference standards are used in any of those quantitative tests. The reference standards which have been newly established since the JP17th Edition Supplement I and the new lots of reference standards which have been released since 2019 have been provided their purity calculated by the mass balance method as the correction factors.

2-A13　As explained in 2-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.

3-A1　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.

4-A1　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 visit the PMRJ Reference Standards Online Store.

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

For ordering them, please contact the Murayama Branch of NIID
Tel : +81-425-61-0771
Fax : +81-425-65-3315

4-A2　Please follow the steps below to order PMRJ Reference Standards:
1. Create an account from here.
2. Receive  an account registration notification. 
3. Visit PMRJ Reference Standards Online Store.
4. Add the product to your cart.
      To generate a quote, proceed to Step 5.
      To place an order directly, skip Step 5.
5. Review the quote summary and generate a quote.
    You can place an order directly from the quote. 
6. Review the Checkout page and click “Complete Order” after accepting our Terms and Conditions.
7. The order confirmation and invoice will be uploaded to Order History under My Account.
8. Please remit  the full invoice amount upon receipt of the order confirmation and invoice.
9. Once full payment is received, your order will be shipped, subject to cargo space availability.

For more detailed instructions, please refer to User Guide.

4-Q3　No. All JP reference standards we supply are for laboratory testing only. They cannot be used in humans or animals.

5-A1　No. Each login ID must have only one email address, and each email address can be used for only one login ID. We suggest registering a group email address so that document upload notifications are sent to everyone who needs them.

5-A2　Registration is required to request a quote. Please create an account from here.
Usually, the quote is created automatically. However, for some delivery areas, we will send it to you within a few days.

5-A3　It measns the product with UN number (United Nation Number),which must be shipped to Airport by Air not by courier service.

5-A4　It means the product is currently available in limited quantities. Depending on the quantity you order, we may contact you.

5-A5　Information on international shipping availability is provided in Shipping Conditions section on each product detail page.
Products that are not available for overseas shipping cannot be added to the cart.

5-A6　No, we only distribute Reference Standards listed in Chapter 9.01 of the Japanese Pharmacopoeia. Products not shown in our online store are not available.

5-A7　We only distribute the products listed in our online store, but content amounts may change with new lots.

6-A1　Shipping charges vary depending on the required shipping conditions and the delivery destination, and will be quoted separately.
For more details, please refer to SHIPPING in User Guide.

6-A2　Once full payment has been confirmed, we will arrange shipment of your order.
For air cargo shipments, orders are generally dispatched within 1–2 weeks after flight space is secured.

Please note that this refers to the time of shipment, not the estimated delivery date.

6-A3　Frozen products cannot be shipped together with products that require a different temperature. Please place separate orders.

6-A4　No. We ship each order separately. To combine items, please place one order together before completing your payment.

6-A5　Data loggers are not included by default. If you need a quote, please Contact Us. If not, write “Data logger required” in the Remarks field at checkout. We will then send a quote or invoice and add it to your order.

6-A6　If the destination country does not appear during checkout, please request a quote. We will issue the quote within a few days.

6-A7　No. If you haven’t completed payment yet, please place a new order. If you have already paid, please Contact Us with your order number.

6-A8　If you have not yet made payment, your order will be automatically canceled. After payment, contact us right away with your invoice number. Once an order has been shipped, it cannot be canceled.

6-A9　Yes, under EXW (Incoterms® 2020) terms, you can choose your own carrier.

Courier shipments: You need to provide your account number.
Air cargo shipments: We will contact you after your order.

6-A10　Before payment: If you placed an order but haven’t paid, please make a new order with the correct address and ignore the old invoice.

After payment: If you have already paid, contact us right away with your invoice number or order number. We will try to adjust the shipment, but we may not be able to do so in every case.

6-A11　Shipping terms vary by product. Typically, we use international courier services.  On the other hand, frozen, refrigerated, and dangerous goods products are shipped by Air cargo to the airport only. You must arrange transportation from the airport to your warehouse or office.

6-A12　Yes. If your order was set for courier but needs Air cargo, you can:
・Send a request on the Contact Us page, or
・Write in the Remarks section at checkout that you want Air cargo.
We will update your invoice with the new shipping charges.

6-A13　No. Courier shipments are at room temperature, so we cannot guarantee the quality. Frozen, refrigerated, and dangerous goods products cannot be sent by courier. They must be shipped by Air cargo.

6-A14　You can either:
・Write a note in the Remarks section at checkout. 
・Contact us after ordering with your order number.
We will check if delivery to your address is possible and let you know the shipping cost.

7-A1　Payment must be made in advance. We only accept payment in Japanese Yen (JPY).
You are responsible for any bank transfer fees. Orders will be shipped only after full payment has been received.

7-A2　Our banking information is provided on the invoice issued after you place an order.

7-A3　No. Please place a new order through the online store. If the price has changed since your previous order, additional payment may be required.

7-A4　Please contact us with your invoice number or Order number. 

Overpayment:
We will either refund the excess amount or issue a credit note. Please note that any bank fees for refunds are your responsibility.

Underpayment:
We will issue a debit note for the outstanding balance. Please select “OUR” in field 71A to cover all bank fees when making the additional payment.

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8-A1　Yes. A short time at room temperature during delivery will not affect the product. Please put it in the recommended storage temperature right after you receive it.

8-A2　We do not offer customs clearance service. We suggest that you have a customs broker handle customs clearance for Air conception or FedEx/DHL handle customs clearance for courier shipments depending on the shipping method. You are responsible for any duties and taxes imposed on JPRS products.

8-A3　Yes. But documents cannot be attached at checkout. Please send any required documents with Order number through Contact Us.

8-A4　No, we do not have agents for the distribution of our reference standards anywhere in the world.

8-A5　No.We do not offer discounts on our products.

8-A6　Shipping costs are subject to change without notice. We kindly request that you check the actual shipping costs on your quote or invoice.

8-A7　The lot number of the product to be shipped will be confirmed only after payment confirmation. If a new lot is assigned at that time, the net weight may change accordingly.

8-A8　No, IBAN codes are not used in Japan. Instead, the invoice includes the bank name and SWIFT/BIC code for international transfers.

8-A9　Please enter a temporary number (not your real ID). We’ll contact you later with the details needed for shipping.

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