Research Standards
PepGenex research materials undergo independent third-party analytical testing. COA available on request.
What each certificate reports
- Identity confirmation
- Measured quantity of each component
- HPLC purity, reported against a specification of greater than 98.0%
- Endotoxin by LAL (limit 5.0 EU/mL)
- Rapid Sterility Screening (PCR), result: Not Detected
- Lot code and sample code
- Date received and date published
- Laboratory review and director certification
- Sample code verification through the laboratory
Identity confirmation
Establishes: that the laboratory's identity method matched the sample to the named compound. ICH Q6B states that identity tests should be highly specific and that more than one test may be necessary (ICH Q6B, FDA docket FDA-1998-D-0003).
Does not establish: how much of the compound is present or how pure it is; ICH Q6B notes that identity tests can be qualitative.
Measured quantity of each component
Establishes: the amount of each component the laboratory measured in the sample. ICH Q6B lists quantity as a separate specification item from identity and purity (ICH Q6B, FDA docket FDA-1998-D-0003).
Does not establish: identity or purity, which are reported separately.
HPLC purity
Establishes: the purity result of a high-performance liquid chromatography method on the sample, compared against the stated specification of greater than 98.0%.
Does not establish: identity, endotoxin or microbial content. ICH Q6B states that purity results are method dependent and are usually estimated by a combination of methods (ICH Q6B, FDA docket FDA-1998-D-0003).
Endotoxin by LAL
Establishes: the endotoxin level measured by a Limulus amebocyte lysate (LAL) assay, reported against a limit of 5.0 EU/mL. Endotoxin is the lipid A of Gram-negative bacterial lipopolysaccharide (Raetz and Whitfield 2002, PMID 12045108).
Does not establish: the absence of other microbial contaminants. FDA guidance notes that endotoxin assays are subject to interference from the test article (FDA, Pyrogen and Endotoxins Testing: Questions and Answers, docket FDA-2013-S-0610).
Rapid Sterility Screening (PCR)
Establishes: the laboratory's reported result for the Rapid Sterility Screening (PCR) listed on the certificate, for the sample tested, reported as Not Detected.
Does not establish: this screening is a detection result for the sample tested and does not by itself establish the sterility of every unit or a validated sterility assurance.
Lot code, sample code and dates
Establishes: which lot and which sample the results belong to, and when the sample was received and the certificate published. ICH Q7 describes a certificate as issued for a batch and naming its batch number (ICH Q7 section 11.4, FDA docket FDA-1995-D-0288).
Does not establish: results for any other lot.
Laboratory review, director certification and sample code verification
Establishes: that the laboratory reviewed and certified the reported results, and that the sample code can be checked with the laboratory. ICH Q7 describes certificates as dated and signed by authorized personnel (ICH Q7 section 11.4).
Does not establish: the regulatory status of the material or its suitability for any use. A certificate is a record of test results.
Obtaining a certificate
Certificates of analysis are available on request. Include the lot code. The lot code is printed on the vial label. Requests go to info@pepgenex.com.
Further reading
PepGenex ScienceMethodologyGlossaryLyophilizationPeptideHow to evaluate a research peptide supplierU.S. processing and testing of research peptides