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Chorionic Gonadotropin (HCG) is a dry, sterile preparation of placental glucoprotein. It is indicated for male hypogonadism secondary to pituitary failure, induction of ovulation and pregnancy in the infertile women. <P>&nbsp;</P> <P><br />Haoran Biopharma can supply bulk HCG with the following specifications. Products of various specifications can also be prepared according to customers’ requests.</P> <P>&nbsp;</P> <P> <TABLE border="1" cellSpacing="0" cellPadding="0"> <TBODY> <TR> <TD vAlign="top" width="284"> <DIV>Appearance</DIV></TD> <TD vAlign="top" width="284"> <DIV>White to yellowish-white powder</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Identification</DIV></TD> <TD vAlign="top" width="284"> <DIV>Identified</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 5,000 IU/mg</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Water</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 5.0%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Bacterial endotoxins</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 0.01 EU/HCG IU</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Abnormal toxicity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative at 2000 IU/0.5ml/mouse</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Residual Solvent</DIV></TD> <TD vAlign="top" width="284"> <DIV>0.5%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HIV I+II antigen</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative </DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Hepatitis B surface antigen</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HCV antibodies</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR></TBODY></TABLE></P> Chorionic Gonadotropin (HCG)
Human Menopausal Gonadotropin (HMG) is a sterile preparation containing glycoprotein gonadotropin extracted from human post-menopausal urine. It contains both Follicle Stimulating Hormone (FSH) and Luteinising Hormone (LH). <P>&nbsp;</P> <P>The substance has the property in females of stimulating growth and maturation of ovarian follicles and property in males of maintaining and stimulating testicular, interstitial cells related to testosterone production and of being responsible for the full development and maturation of spermatozoa in the seminiferous tubules.</P> <P>&nbsp;</P> <P>The substance is indicated for the induction of ovulation in the anovulatory woman with regular or irregular cells. For men, it is indicated for the stimulation of spermatogenesis in men who have primary or secondary hypogonadotropic hypogonadism.</P> <P>&nbsp;</P> <P>Haoran Biopharma can supply bulk HMG with the following specifications. Products of various specifications can also be prepared according to customers' requests.</P> <P><br />&nbsp;</P> <P> <TABLE border="1" cellSpacing="0" cellPadding="0"> <TBODY> <TR> <TD vAlign="top" width="284"> <DIV>Appearance</DIV></TD> <TD vAlign="top" width="284"> <DIV>Almost White or slightly yellow powder</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Solubility</DIV></TD> <TD vAlign="top" width="284"> <DIV>Freely soluble</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Identification</DIV></TD> <TD vAlign="top" width="284"> <DIV>Identified</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>FSH activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 200 IU-FSH/mg</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>LH activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 200 IU-LH/mg</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>FSH:LH</DIV></TD> <TD vAlign="top" width="284"> <DIV>About 1:1</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Water</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 5.0%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Residual Solvent</DIV></TD> <TD vAlign="top" width="284"> <DIV>0.5%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Bacterial endotoxins</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 1.0 EU/FSH IU</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Abnormal toxicity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative at 100 IU/0.5ml/mouse</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HIV I+II antibody</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative </DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Hepatitis B surface antigen</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HCV antibodies</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR></TBODY></TABLE></P> Human Menopausal Gonadotropin (HMG)
Follicle-stimulating hormone (FSH) is a hormone found in humans and other animals. It is synthesized and secreted by gonadotrophs of the anterior pituitary gland. FSH regulates the development, growth, pubertal maturation, and reproductive processes of the body. <P>&nbsp;</P> <P>In both males and females, FSH stimulates the maturation of germ cells. In males, FSH induces Sertoli cells to secrete inhibin and stimulates the formation of sertoli-sertoli tight junctions. In females, FSH initiates follicular growth, specifically affecting granulosa cells. With the concomitant rise in inhibin B, FSH levels then decline in the late follicular phase. This seems to be critical in selecting only the most advanced follicle to proceed to ovulation. At the end of the luteal phase, there is a slight rise in FSH that seems to be of importance to start the next ovulatory cycle.</P> <P>&nbsp;</P> <P>Haoran Biopharma can supply bulk FSH with the following specifications. Products of various specifications can also be prepared according to customers' requests.</P> <P>&nbsp;</P> <P> <TABLE border="1" cellSpacing="0" cellPadding="0"> <TBODY> <TR> <TD vAlign="top" width="284"> <DIV>Appearance</DIV></TD> <TD vAlign="top" width="284"> <DIV>Almost White or slightly yellow powder</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Solubility</DIV></TD> <TD vAlign="top" width="284"> <DIV>Freely soluble</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>FSH activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 200 IU /mg</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>FSH:LH</DIV></TD> <TD vAlign="top" width="284"> <DIV>About 60:1</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Water</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 5.0%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Bacterial endotoxins</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 0.4 EU/FSH IU</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HIV I+II antibody</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative </DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Hepatitis B surface antigen</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HCV antibodies</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR></TBODY></TABLE></P> Follicle Stimulating Hormone (FSH)
Urokinase (UK) is a thrombolytic agent extracted from human fresh urine. It can activate plasminogen to plasmin, with the subsequent hydrolysis of fibrin and dissolution of thrombi. <P>&nbsp;</P> <P>This product is mainly used in the treatment of acute myocardial infarction, acute cerebral thrombosis, occlusion of cerebral blood vessel, peripheral arteriovenous thrombi, central retinal arteriovenous thrombi and other infarction diseases due to freshly formed clot</P> <P>&nbsp;</P> <P>Haoran Biopharma can supply bulk UK with the following specifications. Products of various specifications can also be prepared according to customers' requests.</P> <P><br />&nbsp;</P> <P> <TABLE border="1" cellSpacing="0" cellPadding="0"> <TBODY> <TR> <TD vAlign="top" width="284"> <DIV>Appearance</DIV></TD> <TD vAlign="top" width="284"> <DIV>White or almost white, amorphous powder</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Identification</DIV></TD> <TD vAlign="top" width="284"> <DIV>Identified</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 80,000 IU/mg</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Specific activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 120,000 IU/mg protein</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Clarity of solution</DIV></TD> <TD vAlign="top" width="284"> <DIV>Clear</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Thromboplastic contaminants</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 150 IU/ml</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HMW-Urokinase</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 90%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Bacterial endotoxins</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 1.0 EU /10,000 IU</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Abnormal toxicity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative at 5000 IU/0.5ml/mouse</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HIV I+II antibody</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative </DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Hepatitis B surface antigen</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HCV antibodies</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR></TBODY></TABLE></P> Urokinase (UK)
Ulinastatin (Urinary Trypsin Inhibitor, UTI) is a kind of glucoprotein dervied from human urine. As a proteinase inhibitor, it inhibits the activity of trypsin, chymotrypsin, lactate. Lipase, hyaluronidase and other pancreatic enzymes. <P>&nbsp;</P> <P>UTI is an effective drug in the treatment of acute pancreatitis, chronic recurrent pancreatitis and hemorrhagic, traumatic and endotoxic shocks.</P> <P>&nbsp;</P> <P>Haoran Biopharma can supply UTI bulk with the following specifications. Products of various specifications can also be prepared according to customers' requests.</P> <P>&nbsp;</P> <P> <TABLE border="1" cellSpacing="0" cellPadding="0"> <TBODY> <TR> <TD vAlign="top" width="284"> <DIV>Appearance</DIV></TD> <TD vAlign="top" width="284"> <DIV>White or off-white powder</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Identification</DIV></TD> <TD vAlign="top" width="284"> <DIV>Identified</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Specific activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not less than 3500 IU/mg protein</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>pH</DIV></TD> <TD vAlign="top" width="284"> <DIV>6.0-7.5</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Kallikrein </DIV></TD> <TD vAlign="top" width="284"> <DIV>Pass</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Impurity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 2%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Thromboplastic contaminants</DIV></TD> <TD vAlign="top" width="284"> <DIV>Pass</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Bacterial endotoxins</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 1.25 EU/10,000 IU</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Abnormal toxicity</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative at 45000 IU/0.5ml/mouse</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Loss on drying</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 6%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HIV I+II antibody</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative </DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Hepatitis B surface antigen</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>HCV antibodies</DIV></TD> <TD vAlign="top" width="284"> <DIV>Negative</DIV></TD></TR></TBODY></TABLE></P> Ulinastatin (Urinary Trypsin Inhibitor, UTI)
Enoxaparin sodium is the sodium salt of a low-molecular-mass heparin that is obtained by alkaline depolymerisation of the benzyl ester derivative of heparin from porcine intestinal mucosa. The majority of the components have a 4-enopyranose uronate structure at the nonreducing end of their chain <P>&nbsp;</P>It is mainly indicated for the prophylaxis of Deep Venous Thrombosis (DVT) and pulmonary embolism, treatment of venous thrombosis, prevention of clotting during hemodialysis, treatment of unstable angina and non-Q-wave myocardial infarction. <P>&nbsp;</P> <P>Haoran Biopharma can supply bulk Enoxaparin Sodium with the following specifications. Products of various specifications can also be prepared according to customers' requests.</P> <P>&nbsp;</P> <P> <TABLE border="1" cellSpacing="0" cellPadding="0"> <TBODY> <TR> <TD vAlign="top" width="284"> <DIV>Appearance</DIV></TD> <TD vAlign="top" width="284"> <DIV>White or almost white powder, hygroscopic</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Solubility</DIV></TD> <TD vAlign="top" width="284"> <DIV>Freely soluble in water</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Identification</DIV></TD> <TD vAlign="top" width="284"> <DIV>A.&nbsp;&nbsp;&nbsp; The spectrum obtained is similar to enoxaparin sodium CRS</DIV> <DIV>B.&nbsp;&nbsp;&nbsp; The ratio of Anti-factor Xa activity to anti-factor IIa activity: 3.3-5.3</DIV> <DIV>The mass-average relative molecular mass ranges between 3800 and 5000</DIV> <DIV>C.&nbsp;&nbsp;&nbsp; The mass percentage of chains lower than 2000:12.0%~20.0%</DIV> <DIV>The mass percentage of chains between 2000 and 8000: 68.0%~82.0%</DIV> <DIV>D.&nbsp;&nbsp;&nbsp; It gives reaction (a) of sodium</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Appearance of solution (10% solution w/v)</DIV></TD> <TD vAlign="top" width="284"> <DIV>The solution is clear and not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>pH (10% W/V solution)</DIV></TD> <TD vAlign="top" width="284"> <DIV>6.2~7.7</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Specific absorbance (dried substance)</DIV></TD> <TD vAlign="top" width="284"> <DIV>14.0~20.0</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Nitrogen (dried substance)</DIV></TD> <TD vAlign="top" width="284"> <DIV>1.5%~2.5%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Sodium (dried substance)</DIV></TD> <TD vAlign="top" width="284"> <DIV>11.3%~13.5%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Heavy metals</DIV></TD> <TD vAlign="top" width="284"> <DIV>≤30ppm</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Loss on drying</DIV></TD> <TD vAlign="top" width="284"> <DIV>≤10.0%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Molar ratio of sulfate ions to carboxylate ions</DIV></TD> <TD vAlign="top" width="284"> <DIV>≥1.8</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Bacterial endotoxins</DIV></TD> <TD vAlign="top" width="284"> <DIV>N.M.T. 0.01 EU/1 IU anti-factor Xa activity</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Assay (dried substance)</DIV></TD> <TD vAlign="top" width="284"> <DIV>Anti-factor Xa activity: 90 IU-125 IU/mg</DIV> <DIV>Anti-factor IIa activity: 20 IU-35 IU/mg</DIV> <DIV>The ratio of anti-factor Xa activity to anti-factor IIa activity: 3.3~5.3</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Benzyl alcohol</DIV></TD> <TD vAlign="top" width="284"> <DIV>≤0.1% (m/m)</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Residual ethanol</DIV></TD> <TD vAlign="top" width="284"> <DIV>≤5000 ppm</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Microbial enumeration tests</DIV></TD> <TD vAlign="top" width="284"> <DIV>Total aerobic microbial count: ≤1000cfu/g</DIV> <DIV>Total combined yeast/moulds count: 100cfu/g</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Test for specified micro-organisms</DIV></TD> <TD vAlign="top" width="284"> <DIV>Escherichia coli: not detected/g</DIV></TD></TR></TBODY></TABLE></P> Enoxaparin Sodium
Dalteparin Sodium (Low Molecular Weight Heparin Sodium) (LMWH-Na) is the sodium salt of Low Molecular Weight Heparin obtained by nitrous acid depolymerization of heparin from pork intestinal mucosa. <P>&nbsp;</P> <P>As a new antithrombotic class, Dalteparin Sodium provides immediate and sustained antithrombotic activity when administered in prophylactic or therapeutic dosage. It is indicated for prevention of clotting during hemodialysis and prophylaxis of Deep Venous Thrombosis (DVT).</P> <P>&nbsp;</P> <P>Haoran Biopharma can supply bulk Dalteparin Sodium with the following specifications. Products of various specifications can also be prepared according to customers' requests.</P> <P>&nbsp;</P> <P> <TABLE border="1" cellSpacing="0" cellPadding="0"> <TBODY> <TR> <TD vAlign="top" width="284"> <DIV>Appearance</DIV></TD> <TD vAlign="top" width="284"> <DIV>White or almost white powder</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Clarity of solution</DIV></TD> <TD vAlign="top" width="284"> <DIV>Clear</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Anti-factor Xa activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>110AXa IU/mg ~ 210AXa IU/mg</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Anti-factor IIa activity</DIV></TD> <TD vAlign="top" width="284"> <DIV>35 AIIa IU/mg-100 AIIa IU/mg</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>The ratio of anti-factor Xa to anti-factor IIa</DIV></TD> <TD vAlign="top" width="284"> <DIV>1.9 ~ 3.2</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Sodium</DIV></TD> <TD vAlign="top" width="284"> <DIV>9.5% ~ 12.5%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Range of molecular weight</DIV></TD> <TD vAlign="top" width="284"> <DIV>&lt;3000: Not more than 13.0%</DIV> <DIV>&gt;8000: 15.0% ~ 25.0%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Mass-average molecular mass</DIV></TD> <TD vAlign="top" width="284"> <DIV>5600 ~ 6400</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>pH</DIV></TD> <TD vAlign="top" width="284"> <DIV>5.5 ~ 8.0</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Nitrite</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 5ppm</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Nitrogen</DIV></TD> <TD vAlign="top" width="284"> <DIV>1.5% ~ 2.5%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Heavy metals</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 30ppm</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Loss on drying</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 5.0%</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Nucleotide and protein impurities of the source material</DIV></TD> <TD vAlign="top" width="284"> <DIV>Pass</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Boron</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 1ppm</DIV></TD></TR> <TR> <TD vAlign="top" width="284"> <DIV>Bacterial endotoxins</DIV></TD> <TD vAlign="top" width="284"> <DIV>Not more than 0.01IU/AXaIU</DIV></TD></TR></TBODY></TABLE></P> Dalteparin Sodium (Low Molecular Weight Heparin Sodium)

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