Gemfibrozil Cas 25812-30-0
Specification
Items | Specifications | Results |
Appearance | White crystalline powder | White crystalline powder |
Identification | A.The sample IR absorption spectrum should match the reference standard | A:Match with the RS IR absorption spectrum. |
B.The retention time of the major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay. | B.The retention time of the major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay. |
Water | Not more than 0.25% | 0.01% |
Related compounds | Related compound A:Not more than 0.10% Any other individual impurity:Not more than 0.08% Total impurities:Not more than 0.5% | ＜0.01% ＜0.01% 0.03% |
Residual solvents | Tatrahydrofuran:Not more than 720 ppm Ethyl formate:Not more than 5000 ppm | ＜LOD(1 ppm) 38ppm |
Assay,on anhydrous basis | 98.0%~102.0% | 99.9% |
Conclusion | The product conforms to the above specifications. |
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Gemfibrozil is a prescription medication belonging to the fibrate class of drugs. Its primary use is to treat certain types of abnormal blood lipid (fat) levels, specifically by lowering high triglycerides and raising high-density lipoprotein (HDL or "good") cholesterol.
Common Brand Names: Lopid® (U.S.), generic forms available.
Primary Medical Uses & Indications
Gemfibrozil is used to manage dyslipidemia (abnormal cholesterol/triglyceride levels) in specific high-risk situations:
Severe Hypertriglyceridemia: It is very effective at treating very high levels of triglycerides (type IV and V hyperlipidemia). This is crucial to prevent acute pancreatitis, a serious and painful inflammation of the pancreas that can be triggered by extremely high triglycerides.
Mixed Dyslipidemia: For patients with a combination of high triglycerides and low HDL cholesterol, often seen in metabolic syndrome. It is used to reduce the risk of coronary heart disease (CHD) in patients who have not responded adequately to diet, exercise, and other interventions like weight loss.
Important Note: Its role in directly preventing heart attacks is more limited and specific compared to statins (like atorvastatin). It is not a first-line medication for simply lowering "bad" LDL cholesterol.
How It Works (Mechanism of Action)
Gemfibrozil works primarily by activating a receptor in the cell nucleus called PPAR-alpha (Peroxisome Proliferator-Activated Receptor-alpha). This activation leads to:
Increased breakdown of triglyceride-rich particles in the blood.
Decreased production of triglycerides by the liver.
Increased production of HDL cholesterol ("good cholesterol").
A modest decrease in LDL cholesterol in some patients.
Important Considerations & Side Effects
Common Side Effects:
Serious Side Effects & Risks (Require immediate medical attention):
Muscle Problems: Unexplained muscle pain, tenderness, or weakness (myopathy or rhabdomyolysis), especially when taken with a statin drug. This combination significantly increases the risk.
Liver Problems: Abnormal liver function tests; symptoms include nausea, vomiting, loss of appetite, yellowing of skin/eyes (jaundice), dark urine.
Gallstones: Fibrates can increase cholesterol secretion into bile, raising the risk of gallstones.
Blood Cell Changes: Can rarely cause anemia or decrease in white blood cells.
Key Drug Interactions:
STATINS (e.g., atorvastatin, simvastatin): High risk of severe muscle damage. Combination therapy is generally avoided or used with extreme caution and close monitoring.
Blood Thinners (Warfarin): Gemfibrozil can increase warfarin's effect, raising the risk of bleeding. Frequent INR monitoring is required.
Repaglinide (a diabetes drug): Gemfibrozil can drastically increase its levels, causing dangerous hypoglycemia (low blood sugar).
Other cholesterol drugs like ezetimibe: May increase the risk of gallstones.
Contraindications (Who Should NOT Take It)
Patients with severe kidney or liver disease.
Patients with gallbladder disease.
Patients with a history of hypersensitivity to gemfibrozil.
Pregnancy or breastfeeding.
Patient Guidelines (If Prescribed)
Lifestyle First: The medication is an adjunct to, not a replacement for, a crucial heart-healthy lifestyle. This includes a low-fat, low-cholesterol diet, regular exercise, weight loss if needed, and smoking cessation.
Adherence: Take the medication exactly as prescribed, typically 30 minutes before breakfast and dinner.
Monitoring: Regular blood tests are needed to check lipid levels, liver function, and blood counts.
Report Symptoms: Immediately report any unexplained muscle pain, dark urine, severe stomach pain, or signs of jaundice to your doctor.
Inform All Providers: Always tell all your healthcare providers you are taking gemfibrozil, especially before starting any new medication.
In summary, Gemfibrozil is a fibrate drug used primarily to treat dangerously high triglyceride levels and to improve the cholesterol profile (high TG, low HDL) in selected patients at risk for heart disease. Its use requires careful medical supervision due to significant side effects and drug interaction risks, particularly with statin medications.
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Contact information
Spring Zhang
Email: export@fortunachem.com
Skype: Fortunachem201304
QQ:3169620873
Tel: +86-27-59207892
Website: www.fortunachem.com
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