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各国薬局方にトレーサブルな二次標準物質(Secondary Standard)

私たちの二次標準物質(Secondary Standard)はUSP、EP、BP標準品にマルチトレーサブルです。さらに、標準品製造の最も良いレベルである、ISO/IEC 17025 と ISO Guide 34の認定をうけ製造しています。 FDA、USP、EPは対応する1次標準(primary standard)を用いて確立した二次標準物質やワーキングスタンダードの使用を認めています。メソッドにおける二次標準の位置づけ

※USP:米国薬局方(United States Pharmacopeia) EP:欧州薬局方(European Pharmacopoeia)BP: 英国薬局方(British Pharmacopoeia) FDA:アメリカ食品医薬品局(Food and Drug Administration)




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  • 米国薬局方(USP)、ヨーロッパ薬局方(EP),英国薬局方(BP)標準物質に可能な限りマルチトレーサブル
  • 薬局方モノグラフの試験法を用い、GMPに適合した装置で分析
  • ISOGuide34とISO17025に従った重量法を用いた認証値
  • ISO Guide31に従った認証書






  • 対応する薬局方とのトレーサビリティのとれた分析値
  • 重量法による値(ISO17025に従った)
  • ハンドリングと保存条件
  • 分析データ

薬局方二次標準物質 COAアップデート(毎月)
Customers are notified in advance of any COA changes that may occur due to re-qualification etc.
This service helps users ensure that they always have the most current version of a product certificate.
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(1) Human Drug CGMP Notes, Vol 9, Number 3, 2001 (Internal FDA Publication):

Q: Can a company use reference standards from sources other than the USP?

A: Yes. Using a source other than USP can be acceptable provided the reference standard incorporates the critical characteristic properties, is suitable for the intended purpose, and is supported by complete documentation…..The supplier’s certificate of analysis should report results of testing to adequately characterize the material across a complete range of quality characteristics.

(2) FDA: Guidance for Industry; Analytical Procedures and Methods Validation, August 2000:

“A reference standard (i.e., primary standard) may be obtained from the USP/NF or other official sources (e.g., CBER, 21 CFR 610.0). A working standard (i.e., in-house or secondary standard) is a standard that is qualified against and used instead of the reference standard.”

(3) United States Pharmacopeia, General Chapter <1010>:

“Use of Reference Standards: Where the use of USP Reference Standards is specified, the USP Reference Standard, or a secondary standard traceable to the USP Reference Standard, is used.”

(4) European Pharmacopoeia, Chapter 5.12:

“Secondary standard: A standard established by comparison with a primary standard. A secondary standard may be used for routine quality control purposes for any of the uses described above for primary standards provided that it is established with reference to the primary standard.”