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Bachem Holding (Suzhou): difference between revisions

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Revision 13 — 02:16, 30 Jan 2025
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Revision 14 — 10:44, 14 Feb 2025
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52Submitted reports on BCH material to July 2026 span the incretin range and a set of repair peptides. Reported [[Area percent purity|area percent]] figures have been high and consistent with the accompanying certificates where both are available.{{r|reports}}52Submitted reports on BCH material to July 2026 span the incretin range and a set of repair peptides. Reported [[Area percent purity|area percent]] figures have been high and consistent with the accompanying certificates where both are available.{{r|reports}}
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+54The set includes one report on a sequence for which no [[Reference standard|certified reference standard]] is commercially available. A purity figure obtained without a qualified standard is a statement about relative peak areas and cannot be converted into a potency; that limitation applies to the report and not to the material.{{r|usp1503,iso17025}}
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54== References ==56== References ==
55{{reflist}}57{{reflist}}
58<ref name="reports">Independent test reports submitted to PeptidePedia by purchasers, 2024–2026. Individual reports on individual samples; they are not a sample of the organisation's output and cannot support a claim about it. See [[Blind sampling]].</ref>60<ref name="reports">Independent test reports submitted to PeptidePedia by purchasers, 2024–2026. Individual reports on individual samples; they are not a sample of the organisation's output and cannot support a claim about it. See [[Blind sampling]].</ref>
59<ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref>61<ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref>
+62<ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref>
+63<ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''. International Organization for Standardization.</ref>
60<ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref>64<ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref>
61<ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a GMP claim is assessed.</ref>65<ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a GMP claim is assessed.</ref>
+66
+67== See also ==
+68* [[Certificate of analysis]]
+69* [[Third-party testing]]
+70* [[Area percent purity]]
+71* [[Peptide content]]
+72* [[Research use only]]
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63{{DEFAULTSORT:Bachem Holding (Suzhou)}}74{{DEFAULTSORT:Bachem Holding (Suzhou)}}