Quality Inspection for Heterocyclic Amino Acids - GLP-1 Protected Amino Acid for Side Chain Modification – Gentolex

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Quality Inspection for Heterocyclic Amino Acids - GLP-1 Protected Amino Acid for Side Chain Modification – Gentolex Detail:

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NO.	Products	CAS No.	Application	Key Quality Indicator
NO.	Products	CAS No.	Application	Purity	Isomer	SI *	Max *	Moisture
1	Fmoc-Lys(Mtt)-OH	167393-62-6	Lysine side chain modification	≥99.0%	≤0.1%	≤0.2%	≤0.3%	≤1.0%
2	Fmoc-Lys(Alloc)-OH	146982-27-6	Lysine side chain modification	≥99.5%	≤0.1%	≤0.1%	≤0.2%	≤1.0%
3	Fmoc-Lys(ivDde)-OH	150629-67-7	Lysine side chain modification	≥98.0%	≤0.2%	≤0.3%	≤0.5%	≤1.0%
4	Fmoc-Lys(Mmt)-OH	159857-60-0	Lysine side chain modification	≥98.0%	≤0.2%	≤0.3%	≤0.5%	≤1.0%
5	Fmoc-Glu-OtBu	84793-07-7	LiraglutideSemaglutide	≥99.5%	≤0.1%	≤0.1%	≤0.2%	≤1.0%
6	Glu-OtBu	45120-30-7	LiraglutideSemaglutide	≥99.5%	≤0.1%	≤0.1%	≤0.2%	≤1.0%
7	Octadecanedioic acid	871-70-5	Semaglutide	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
8	Octadecanedioic acid mono-tert-butyl ester	843666-40-0	Semaglutide	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
9	tBu-OOC-C16-CO-Glu-OtBu	1188328-39-3	SemaglutideFragment A	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
10	AEEA	134978-97-5	SemaglutideAlbuvirtide	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
11	AEEA-OH.HCl	134979-01-4	SemaglutideAlbuvirtide	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
12	Fmoc-AEEA-OH	166108-71-0	SemaglutideAlbuvirtide	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
13	Boc-AEEA-OH	108466-89-3	Semaglutide	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
14	AEEA-AEEA	1143516-05-5	Semaglutide	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
15	Fmoc-AEEA-AEEA-OH	560088-89-3	SemaglutideFragment B	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
16	Octa(OtBu)-Glu(ɑ-OtBu)-AEEA-AEEA-OH	1118767-16-0	SemaglutideFragment C	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
17	tBu-OOC-C16-CO-Glu(AEEA-AEEA-NHS)-OtBu	1118767-15-9	SemaglutideFragment D	≥96.0%	≤0.5%	≤1.0%	≤1.0%	≤1.0%
18	Fmoc-Lys(tBu-OOC-C16-CO-Glu(AEEA-AEEA)-OtBu)-OH	1662688-20-1	Semaglutide Fragment E	≥96.0%	≤0.5%	≤1.0%	≤1.0%	≤1.0%
19	Boc-His(Trt)-OH	32926-43-5	The end is histidine	≥99.5%	≤0.1%	≤0.1%	≤0.2%	≤4.0%
20	Fmoc-Aib-OH	94744-50-0	Semaglutide	≥99.5%	/	≤0.1%	≤0.2%	≤1.0%
21	Boc-His(Trt)-Aib-OH	2061897-68-3	Semaglutide	≥99.0%	≤0.1%	≤0.2%	≤0.3%	≤2.0%
22	Fmoc-Glu(OtBu)-Gly-OH	866044-63-5	GLP-1 analogue	≥99.5%	≤0.1%	≤0.2%	≤0.2%	≤1.0%
23	Boc-His(Trt)-Aib-Glu(OtBu)-Gly-OH	1169630-31-2？	Semaglutide Fragment F	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
24	Boc-His(Trt)-Aib-Glu(OtBu)-Gly-NHS	1169630-40-3	Semaglutide Fragment G	≥96.0%	≤0.5%	≤1.0%	≤1.0%	≤1.0%
25	Fmoc-Arg(pbf)-Gly-OH	660846-80-0	GLP-1 analogue	≥99.5%	≤0.1%	≤0.2%	≤0.2%	≤1.0%
26	Fmoc-Ala-Ala-OH	87512-31-0	GLP-1 analogue	≥99.5%	≤0.1%	≤0.2%	≤0.2%	≤1.0%
27	Fmoc-Thr(tBu)-Phe-OH	1260609-75-3 ?	GLP-1 analogue	≥99.5%	≤0.1%	≤0.2%	≤0.2%	≤1.0%
28	Palmitic acid	1957/10/3	Liraglutide Fragment 1	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
29	Palm-Glu-OtBu	NA	Liraglutide Fragment 2	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
30	Palm-Glu(NES)-OtBu	NA	Liraglutide Fragment 3	≥96.0%	≤0.5%	≤1.0%	≤1.0%	≤1.0%
31	Fmoc-Lys(Palm-Glu-OtBu)-OH	1491158-62-3	Liraglutide	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
32	Hexadecanedioic acid	505-54-4	Insulin degludec	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
33	Hexadecanedioic acid mono-tert-butyl ester	843666-27-3	Insulin degludec	≥99.0%	/	≤0.2%	≤0.3%	≤1.0%
34	tBu-OOC-C14-CO-Glu-OtBu	NA	Insulin degludec Fragment I	≥98.0%	≤0.2%	≤0.5%	≤0.5%	≤1.0%
35	tBu-OOC-C14-CO-Glu(NES)-OtBu	NA	Insulin degludec Fragment II	≥96.0%	≤0.5%	≤1.0%	≤1.0%	≤1.0%

SI *= Specific Impurity

Max*= Max Unknown Impurity

Other Indicator:

- Acetic Acid: ≤0.02% (All Products)

- Ethyl Acetate: ≤0.5% (All Products)

- Alcohol: ≤0.5% (All Products)

Sanitization

Sanitization of distribution system, including loop and storage tank is performed by Pasteurization. When Pasteurization sanitization is performed, the purified water in tank is heated up to 80°C and start to circulate by distribution system. The sanitization lasts 1 hour after reaching 80°C. Sanitization is performed every quarter. The purified water system sanitization logbook was checked with no excursion highlighted.

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