Quality Inspection for Axitinib - GnRH Antagonist Used for Peptides Synthesis – Gentolex

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Quality Inspection for Axitinib - GnRH Antagonist Used for Peptides Synthesis – Gentolex Detail:

Product Detail

NO	Products	CAS No.	Application	Key Quality Indicator
NO	Products	CAS No.	Application	Purity	Isomer	Specific impurity	*Max1	Moisture
1	Fmoc-3-(2-naphthyl)-D-Ala-OH	138774-94-4	Most products	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
2	Ac-3-(2-naphthyl)-D-Ala-OH	37440-01-0	Most products	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
3	Fmoc-3-(3-pyridinyl)-D-Ala-OH	142994-45-4	Most products	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
4	Fmoc-4-chloro-D-Phe-OH	142994-19-2	Most products	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
5	Fmoc-D-Cit-OH	200344-33-8	Cetrorelix	≥99.5%	≤0.1%	≤0.1%	≤0.2%	≤1.0%
6	Fmoc-D-Ala-OH.H2O	79990-15-1	Most products	≥99.5%	≤0.1%	≤0.1%	≤0.2%	≤6.5%
7	Fmoc-D-Aph(tBuCbm)-OH	1433975-21-3	Degarelix	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
8	Fmoc-D-Aph(Cbm)-OH	324017-22-3	Degarelix	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
9	Fmoc-L-Aph(L-Hor)-OH	1253282-31-3	Degarelix	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
10	Fmoc-L-Lys(iPr,Boc)-OH	201003-48-7	Degarelix Abarelix Antide	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
11	Fmoc-N-Me-Tyr(tBu)-OH	133373-24-7	Abarelix	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
12	Fmoc-D-Asn(Trt)-OH	180570-71-2	Abarelix	≥99.0%	≤0.2%	≤0.3%	≤0.3%	≤1.0%
13	Fmoc-HomoArg(Et)2-OH.HCl	1864003-26-8	Ganirelix	≥95.0%	≤0.5%	≤1.0%	≤2.0%	≤2.0%
14	Fmoc-D-HomoArg(Et)2-OH.HCl	2098497-24-4	Ganirelix	≥95.0%	≤0.5%	≤1.0%	≤2.0%	≤2.0%
15	Fmoc-Lys(nicotinoyl)-OH	252049-11-9	Antide	≥98.0%	≤0.2%	≤0.3%	≤0.5%	≤1.0%
16	Fmoc-D-Lys(nicotinoyl)-OH	252049-12-0	Antide	≥98.0%	≤0.2%	≤0.3%	≤0.5%	≤1.0%

* Max1 = Max Unknown Impurity

Other Indicator:

- Acetic Acid: ≤0.02% (All Products)

- Ethyl Acetate: ≤0.5% (All Products)

- Alcohol: ≤0.5% (All Products)

TOC and Conductivity

TOC and conductivity of main supply and return points are monitored periodically. TOC is monitored by QC on every week. Conductivity is monitored online and recorded by purified water station operator once every four hours. The conductivity is monitored at the primary RO, secondary RO, EDI and total return point of distribution system. The specification of purified water is in place and conforms to pre-defined specification which no more than 1.3 µs/cm at 25°C (USP). For main supply and return points, full test. is performed every week, for other using point in the circulating loop, full test is performed once every month. The full test includes characters, pH, nitrate, nitrite, ammonia, conductivity, TOC, non-volatile substances, heavy metals, microbial limits and bacterial endotoxin.

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