SIMVASTATIN WITH BUTYLHYDROXYANISOLE

Simvastatin with Butylhydroxyanisole (BHA) API is a cholesterol-lowering agent used primarily for the treatment of hyperlipidemia, dyslipidemia, and prevention of cardiovascular diseases. Simvastatin belongs to the HMG-CoA reductase inhibitor (statin) class, which effectively reduces LDL cholesterol, triglycerides, and increases HDL cholesterol levels.

The addition of Butylhydroxyanisole (BHA) serves as a stabilizing antioxidant, preventing oxidative degradation of Simvastatin, thereby ensuring long-term stability and potency.

At Bluepill Express, we manufacture and export Simvastatin with BHA Active Pharmaceutical Ingredient (API) under WHO-GMP, ISO 9001:2015, and cGMP-certified standards. Our API meets USP, BP, IP, and EP pharmacopeial specifications, guaranteeing high purity, consistent assay value, and excellent stability performance for tablet, capsule, and combination drug formulations.

Therapeutic Applications:

• Management of hypercholesterolemia and mixed dyslipidemia
• Prevention of coronary heart disease and stroke
• Post-myocardial infarction lipid control therapy
• Adjunct to diet and exercise for cholesterol reduction
• Combination therapy with other lipid-modifying agents

Mechanism of Action:

Simvastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the key enzyme involved in cholesterol biosynthesis in the liver. This inhibition reduces hepatic cholesterol production, increases LDL receptor expression, and enhances uptake of circulating LDL, resulting in lower plasma cholesterol and triglyceride levels.

The inclusion of BHA (Butylhydroxyanisole) prevents oxidative degradation of the statin, maintaining chemical integrity during manufacturing, storage, and formulation.

Technical Specifications:

• Chemical Name: Simvastatin with Butylhydroxyanisole
• Simvastatin Formula: C₂₅H₃₈O₅
• Molecular Weight (Simvastatin): 418.57 g/mol
• CAS Number (Simvastatin): 79902-63-9
• CAS Number (BHA): 25013-16-5
• Appearance: White to off-white crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0% (for Simvastatin content)
• Specific Optical Rotation: +251° to +274°
• Melting Point: 135°C – 140°C
• Solubility: Freely soluble in methanol, ethanol, and chloroform; practically insoluble in water
• Storage Conditions: Store in a cool, dry place below 25°C; protect from light and moisture

Pharmacological Classification:

• Therapeutic Class: HMG-CoA Reductase Inhibitor / Antihyperlipidemic Agent
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Oral Tablets (5 mg, 10 mg, 20 mg, 40 mg)
  • Capsules
  • Fixed-dose combinations with Ezetimibe, Fenofibrate, or Niacin

Quality & Manufacturing – Bluepill Express Standards:

• Manufactured under WHO-GMP and cGMP-compliant facilities
• Stabilized using pharma-grade Butylhydroxyanisole (BHA)
• High assay purity and consistent particle size for optimal bioavailability
• Tested by HPLC and GC for impurity profiling and stability
• COA, MSDS, and DMF available for export registration
• Batch-to-batch reproducibility for formulation reliability

Advantages of Bluepill Express Simvastatin with BHA API:

• Enhanced stability through antioxidant protection (BHA)
• Pharmacopeial-grade purity and potency
• Extended shelf-life due to reduced oxidative degradation
• Excellent compressibility and blend uniformity for tablet production
• Global regulatory compliance and documentation support

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
• Shelf Life: 3 years under recommended storage conditions
• Labeling: As per international pharmacopeial and export norms
• Export Markets: Europe, Africa, Asia-Pacific, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – on request)
  • Stability and validation reports