University of Panama
Specialized Institute of Analysis (IEA)
Official Communication No. IEA-001-2025
June 19, 2025
TO: All users of the Specialized Institute of Analysis
FROM: Dr. GOY E. NAVAS T., IEA Director
SUBJECT: Provisions on Reference Chemical Substances (RCS)
As part of our commitment to quality assurance, analytical traceability, and in compliance with Good Laboratory Practices (GLP),
we inform you that as of this date new provisions will be implemented regarding the reception of Reference Chemical Substances (RCS) within the framework of
regulatory quality control analyses carried out at the IEA.
- Only primary RCS in their original container that have not been re-packaged will be accepted. All primary RCS must be presented in their original container, with intact security seal, sealed by the authorized supplier, accompanied by their respective quality certificate and authenticity seal.
- When the analytical methodology and finished product specifications correspond to an internationally recognized pharmacopeia (e.g., USP, EurPh, BP, among others), the client must provide the primary RCS corresponding to the grade required by that pharmacopeia.
Example: If the methodology described in the USP Acetaminophen Tablets monograph requests an acetaminophen RCS, the USP grade acetaminophen RCS must be provided (Acetaminophen RCS USP). The same applies to other RCS requested in that monograph (e.g., related substances/impurities), which must also be USP grade. - When the pharmaceutical product name ends with the initials of an internationally recognized pharmacopeia, such as “Acetaminophen Tablets BP,” the client must provide the corresponding reference substances in the grade indicated by the mentioned pharmacopeia (Acetaminophen RCS, BP).
- Secondary reference chemical substances (RCS): these must be delivered factory-sealed in their original commercial container with a traceability certificate to the corresponding primary standard. Clients are requested to provide these materials properly sealed with their original factory seal.
Re-packaged secondary RCS will not be accepted, as their integrity and purity cannot be guaranteed, which could compromise the reliability of analytical results. - “Generic” analytical standards whose traceability is not guaranteed will not be accepted. Only primary or secondary reference chemical substances from recognized suppliers, with clear documentation supporting their quality and traceability, will be received.
- “Raw materials” (working standards) that have only been assayed against an RCS will not be accepted. Only primary or secondary RCS with their corresponding technical documentation (complete and authentic certificates of analysis) are valid.
- RCS must be delivered in suitable containers that guarantee their stability, such as amber glass bottles or other appropriate materials (when required by the substance), complying with the storage and transport conditions indicated by the manufacturer (including temperature, humidity, and light protection, as applicable throughout the transport chain until delivery at the IEA).
- Bottles in poor condition or without the manufacturer’s security seal will not be accepted, including those improvisedly closed with materials such as Parafilm or aluminum foil.
“Quality and Competence at the Service of the Community”
2025: “Commemorating the 90th Anniversary of the University of Panama”
Ciudad Universitaria Octavio Méndez Pereira – University Mailroom
Panama, Rep. of Panama
Tel: 523-6264 / 523-6256
Email: goy.navast@up.ac.pa
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Facebook: @IEA_Panama