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Quality Assurance

  1. Quality assurance of PMRJ Reference Standards

    PMRJ Reference Standards are guaranteed to be suitable for the official uses as prescribed in the monograph of the official compendia such as the Japanese Pharmacopoeia. All the prescribed uses of the reference standard are indicated in the accompanying leaflet. The suitability of the reference standards for non-official use cannot be guaranteed.

  2. Quality assurance system

    The candidate materials for use as the reference standards are subjected to collaborative studies at a minimum three labs to evaluate their quality. The data is submitted to the PMRJ Reference Standards Certification Committee composed of the external knowledgeable people that ultimately make a judgment on the suitability of the candidate for the official application. We can distribute the material as a reference standard only after we obtain the quality certification of the committee.

    In addition, we make efforts to secure quality and stable supply of the reference standards by constructing and practicing a quality management system for performing flawlessly all work processes from the procurement of candidate materials to the delivery of the reference standards.

  3. Purchase and storage of PMRJ Reference Standards

    Reference standards produced and distributed by PMRJ are labeled without an expiration date. The suitability of the reference standards for the official use is warranted when dispatched. Thus, only sufficient quantity for immediate use should be purchased. After receipt of the standard, keep it immediately at a temperature specified on the label and use it as soon as possible. PMRJ makes no warranties concerning the continued suitability of the reference standards stored for a prolonged period or previously opened.

    Unless a storage temperature is specified on the label or in the accompanying leaflet, store the reference standard at a temperature below 25 ºC while avoiding freezing. When instructions to store in a dry place are given, store the reference standard in a tight container with a desiccant such as silica gel. Generally, the storage in a dry space is recommended for all the reference standards. Before open the container preserved at low temperature, take precautions to prevent moisture adsorption caused by the temperature difference.
    Download the document: “PMRJ Reference Standards Information for Users”.

  4. Usage of PMRJ Reference Standards

    The reference standards are analytical reagents and not to be used for diagnostic or drug purposes,or for administration to humans or animals.

    The reference standards are specifically required in tests and assays prescribed in the Japanese Pharmacopoeia and other official compendia for pharmaceuticals, excipients and food additives. The reference standards are guaranteed to be suitable for such official uses. All the official uses of the reference standard are indicated in the accompanying leaflet. The suitability of the reference standard for non-official use cannot be guaranteed.

    When a correction factor for the purity is indicated in the accompanying leaflet, the weighed amount of the reference standard must be corrected using the correction factor. When a correction factor for the purity is not indicated in the accompanying leaflet, the reference standard is regarded as being 100.0% pure for the official use(s) in quantitative applications (When an official test or an assay method requires to dry a reference standard or to determine a loss on drying or a water content, the reference standard as dried or anhydrous basis is taken as being 100.0% pure.).

    When an official test or an assay method gives instructions to determine a loss on drying or a water content of a reference standard, the weighed amount of the reference standard must be corrected by using the determined value. If the accompanying leaflet of a reference standard gives a specified value of a loss on drying or a water content, a weighed amount of the reference standard can be corrected by using the value given in the leaflet.
    Download the document: “PMRJ Reference Standards Information for Users”.

  5. Others

    Any information necessary for proper use of the reference standard is given on the accompanying leaflet. No certificate of analysis or other data unnecessary for the official uses of the reference standard are provided.

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