中文名稱:西曲瑞克 CAS No:120287-85-6 分子式:C70H92ClN17O14 外觀:白色粉末

CoA for Cetrorelix Acetate

Product Name: Cetrorelix Acetate
CAS No.: 120287-85-6
Date of Analysis: 2023-04-15

Appearance: White Powder
Molecular Formula: C70H92ClN17O14
Molar Mass: 1431.06 g/mol
Sequence: l}-Ser-Tyr-{D-Cit}-Leu-Arg-Pro-{D-Ala}-NH2

Specification Results:

1. Purity: ≥98.5% (實(shí)測(cè)值)
   • Method: HPLC (High Performance Liquid Chromatography)
   • Result: 98.7%
2. Impurity: ≤0.5% (總和)
   • Method: GC-MS (Gas Chromatography-Mass Spectrometry) & TLC (Thin Layer Chromatography)
   • Result: 0.4% (單個(gè)雜質(zhì) 0.2%，總和0.4%)
3. Water Content: ≤3.0%
   • Method: Karl Fischer Titration
   • Result: 2.8%
4. Residual Solvents:
   • Ethanol: ≤0.5%
     • Result: 0.3%
   • Acetone: ≤0.2%
     • Result: ND (Not Detected)
   • Method: Headspace GC
5. Heavy Metals:
   • Lead (Pb): ≤10 ppm
     • Result: 5 ppm
   • Arsenic (As): ≤2 ppm
     • Result: ND
   • Method: ICP-MS (Inductively Coupled Plasma-Mass Spectrometry)
6. Particle Size Distribution:
   • D10: ≤10 μm
     • Result: 5μm
   • D50: ≤50μm
     • Result: 25μm
   • D90: ≤100μm
     • Result: 75μm
   • Method: Laser Diffraction
7. Assay (Potency): 95.0% - 105.0%
   • Method: Bioassay or Chromatographic Comparison
   • Result: 100.2%

Storage Conditions: Store at 2-8°C, protected from light and moisture.

Packing Size: 1G/Bottle, 10G/Bottle, 50G/Bottle, or as per customer requirement.

Shelf Life: 24 months from the date of manufacture when stored under recommended conditions.

Certification: Complies with all specified quality standards and regulations.