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Parts of a Certificate of Analysis

By Joseph Nebus

ISO Guide 31 sets the standard for ISO Guide 34 accredited manufacturers to properly prepare a Certificate of Analysis (CoA). A standardized CoA must accompany any Certified Reference Material (CRM).

Certificate Components

Name and Address of Certifying Body

The name and address of the certifying company or organization located at the top of the Certificate of Analysis.

Title of Document

The document should be titled "Certificate of Analysis".

Other manufacturers that issue "provisional" certificates tend to confuse clients with information that is incomplete or improperly validated. Some organizations issue "Certificates of Compliance." These documents fail to cite actual lot inspection data, instead reporting historical developmental data. Such variations of the Certificate of Analysis are not ISO Guide 31-compliant and should be approached with caution.

Description of Material

Name of the CRM and its concentration - the type of Reference Material should be identified with sufficient detail to distinguish it from similar materials. The name and the concentration of the matrix should also be clearly listed and quantified.

Reference Material Code and Batch Number

Every CRM has a unique code (catalog number) that distinguishes it from all other CRMs. Additionally, a unique Batch Number (lot number) is assigned to every batch.

Description of CRM

Information describing the CRM, including the purity and lot number of the starting material, or Raws.

The truest measure of purity is to know precisely how clean the CRM in the bottle really is. Knowing that there are low impurities is not enough. Analyzing for Trace Metallic Impurities (TMI) and listing the data of all traces gives scientists a much greater understanding of the solution's purity. Although this is not required by ISO, Inorganic Ventures provides this information within an informational TMI chart as an additional courtesy to our customers.

Intended Use

The primary purpose for which the CRM is issued should be stated directly on the certificate. This statement is not intended to restrict the use for other purposes.

Instructions for the CRM's Correct Use

Usage instructions are included on the Certificate of Analysis and in the accompanying (Material) Safety Data Sheets ((M)SDSs). It is strongly recommended that the reference material be used under the conditions and in the sequences described in the Certificate.

Hazardous Situation

Safety information on the certificate must be accompanied by a (Material) Safety Data Sheet ((M)SDS). The (M)SDS details the nature of any hazard and appropriate precautions for avoiding said hazard. Furthermore, packaging containers must clearly identify any hazardous materials or poisons.

Level of Homogeneity

A solution's homogeneity data appears in this section.

Certified Values and their Uncertainties

Error Budgets must be carefully defined for every product. All significant errors are factored into the Uncertainty Budget. What is taken into account is based on the scientist's experience, knowledge, and the factors significant to the Uncertainty stated.

Every CRM must have a stated Uncertainty that is defined on the Certificate of Analysis.

Traceability

Traceability reported on a Certificate of Analysis

Traceability is defined as the property of the result of a measurement whereby it can be related to stated references, usually national (NIST) or international (CSA and EU) standards, through an unbroken chain of comparisons, all having stated uncertainties. Typically, IV reports a five-step system that ensures the traceability chain.

Values Obtained by Individual Laboratories or Methods

If a collaborating laboratory is employed to check the results of a project, the values they obtain must be reported on the certificate as well. This procedure ensures that the manufacturer has taken sufficient action to Control, Validate and Verify all steps carried out by a collaborator or sub-contractor.

Uncertified Values

These are listed for informational purposes only and should be used as a reference indicator.

Date of Certification

The date on which the CRM is certified and the Certificate of Analysis was first issued should be stated. Where a certificate contains revised values for the same batch of a CRM, the date of all revisions should be given.

Period of Validity

This refers to the CRM's expiration date. This is the most frequently abused element of the CRM Certificate of Analysis. Important factors affect the expiry period — see article: Expiration Facts About Your Standards.

Further Information

Additional information may be provided on an as-needed basis.

Names and Signatures of Certifying Officers

Names of the officials who accept the responsibility for the contents of the Certificate of Analysis must appear on the document.

Dr. Paul Gaines, CEO of Inorganic Ventures and Senior Technical Director, is the the certifying officer. Our QA Administrator is responsible for preparing the certificate and our QC Supervisor approves the certificate.