CEI-MS-14 — worked example

§6Worked example

§6.1Worked example — scoring a real certificate against the standard

1. A certificate for a 5 mg vial of a 39-residue acylated peptide states: product name; batch code matching the vial; "Purity (HPLC): 99.1 %"; "MS: 4813.4"; date of analysis; and the supplier’s name.
2. Critical fields present: product name, batch code, date, laboratory. Four of nine.
3. Critical fields absent: method conditions for the purity determination, so the purity figure cannot be interpreted; expected mass for the identity determination and the resolution at which it was obtained, so the 4813.4 figure cannot be checked and could not distinguish this compound from a near-isobaric analogue; peptide content; water content; counter-ion identity and content.
4. Mass balance cannot be constructed, since three of its four terms are absent.
5. Determination: not conformant. Fields absent are recorded individually in the dossier.
6. The material may be excellent. The certificate does not permit a reader to know that, and the certificate is what the Institute assesses.

§6.2Illustrative mass balance

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
2. United States Pharmacopeial Convention. General Chapter ⟨1225⟩ Validation of Compendial Procedures. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.