Quality Inspection for Manganese Chloride - Cetrorelix Acetate to Prevent Premature Ovulation 120287-85-6 – Gentolex

Product Detail

Synonyms

AC-(D-ALA[3-(2-NAPHTHYL)])-[D-PHE(4-CL)]-(D-ALA[3-(3-PYRIDYL)])-SER-TYR-(D-CIT)-LEU-ARG-PRO-D-ALA-OH;Cetrorelixacetate;CETRORELIX;CETRORELIXACID;CETRIZINEDIHYDROCHLORIDE;ChemicalbookN-Acetyl-3-(2-naphthalenyl)-D-Ala-4-chloro-D-Phe-3-(3-pyridyl)-D-Ala-L-Ser-L-Tyr-N5-(aminocarbonyl)-D-Orn-L-Leu-L-Arg-L-Pro-D-Ala-NH2;Cetrorelixum;Cetrorelixum.

Description

Cetrorelix acetate is a synthetic decapeptide, which is mainly used in assisted reproductive technology to prevent premature ovulation in patients with controlled ovarian stimulation. It is a gonadotropin-releasing hormone (GnRH) antagonist that can compete with endogenous LHRH to bind to receptors on the pituitary cell membrane, thereby inhibiting the secretion of luteinizing hormone (LH) and follicle stimulating hormone (FSH) by the pituitary in a dose-dependent manner.

Cetrorelix acetate is a gonadotropin-releasing hormone (GnRH) antagonist. This product competes with endogenous GnRH for receptors on pituitary cells, thereby inhibiting the release of endogenous luteinizing hormone (LH) and follicle-stimulating hormone (FSH), delaying the appearance of the LH peak, thereby controlling ovulation. The effect of this product is dose-dependent, the inhibitory effect is direct, and is maintained by continuous treatment, without causing an initial increase in progesterone receptor activity followed by a decrease.

Equipment from Quality Department

Electric thermostatic stainless steel water bath

Box type resistance furnace

Electric heating constant temperature drying oven

Heated Incubators

Insoluble particle analyzer

Liquid chromatography

Automatic polarimeter

infrared spectrometer

UV / Visible photometer

Electric heating vacuum drying box

Vertical pressure steamer sterilizer

PH meter

Clarity Tester

Osmolality tester

Cassette Moisture Analyzer

Multi-parameter analyzer

Electric blast drying box

Biochemical incubator

Mold incubator

Aseptic isolator

Total organic carbon detector

Desktop Vacuum Dryer

Comprehensive drug stability test chamber

Constant temperature sink and water bath

Medical refrigerated storage box

Gas Chromatograph

Biological safety cabinet

Clean bench

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.