TFC — correspondence log
Every enquiry the Institute made, why it made it, and the outcome, including enquiries that received no answer.
The Institute assesses documentation, not product. It has purchased nothing, tested nothing and inspected nothing. Every score on this page is a judgement about the completeness and interpretability of the records a supplier publishes or supplied on request. A high score means that a supplier documents its material well. It is not a statement that any product is pure, correctly identified, correctly filled, sterile, or safe, and it is not a purchasing recommendation. The Institute makes no purchasing recommendations.
§5Correspondence log
The Institute records every enquiry it makes to a supplier and the outcome of each, including enquiries that received no answer. A dossier that reports only the information a supplier chose to supply presents the supplier's disclosure decision as the Institute's assessment.
§5.1Enquiry log
Table 3. Correspondence between the Institute and TFC, in date order.
| Sent | Subject | Why the Institute asked | Outcome | Days to reply |
|---|---|---|---|---|
| 30 Apr 2023 | Request for aggregate determination by size-exclusion chromatography | A reverse-phase purity method is blind to aggregation. | Declined | 21 |
| 30 Jun 2023 | Request for stability data supporting a stated in-use period | An in-use claim requires a stability-indicating method applied to the actual presentation. | Declined | 24 |
| 08 Nov 2023 | Request for the chromatographic method underlying a reported purity figure | A purity percentage without its method is not comparable with any other purity percentage. | No response within the standing period | — |
| 13 Feb 2024 | Request for the scope of a claimed accreditation | Accreditation is granted for named tests within a defined scope. | No response within the standing period | — |
| 20 Apr 2024 | Request for endotoxin data on a presentation intended for injection | Endotoxin is the attribute least often measured and among those most likely to matter. | Acknowledged, no substantive response | 40 |
| 11 Jul 2024 | Request for an orthogonal identity confirmation | Retention-time correspondence alone does not distinguish a deletion sequence or a stereochemical variant. | Acknowledged, no substantive response | 32 |
| 07 Nov 2024 | Request for the integration window used in a reported determination | Changing the window changes the reported purity without changing the material. | Answered in part | 32 |
| 21 Mar 2025 | Notification of a factual correction to the dossier | The Institute notifies a supplier of a correction before publishing it. | Answered in part | 40 |
| 01 May 2025 | Request for the integration window used in a reported determination | Changing the window changes the reported purity without changing the material. | No response within the standing period | — |
| 9 enquiries recorded. Correspondence was conducted by the Institute's secretariat in writing. The Institute holds no telephone contact and uses no messaging channel. | ||||
§5.2Right of reply
Tianjin Finder Chemical Co., Ltd. was sent this dossier in draft and given twenty-eight days to respond before publication. A response is published in the supplier's own words where one is received. The Institute corrects errors of fact on evidence and does not alter a judgement because a supplier disagrees with it; a disagreement is published alongside the judgement so that a reader can weigh both.[1]
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.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. 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.