Bisoprolol Fumarate

Bisoprolol Fumarate

Product Name Bisoprolol Fumarate
CAS Number 104344-23-2
Molecular Formula C18H31NO4 · ½ C4H4O4
Molecular Weight 766.96 g/mol (as fumarate salt)
Appearance White to off-white crystalline powder
Assay (HPLC) 98.0% – 102.0% (on dried basis)
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
Heavy Metals ≤ 10 ppm
Solubility Sparingly soluble in water, freely soluble in methanol, slightly soluble in ethanol
Package 25 kg net in fiber drum with double polyethylene liner

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Bisoprolol Fumarate Structure

Synonyms: Bisoprolol fumarate, 104344-23-2, EMD 33512, Bisoce, Bisoprolol hemifumarate, (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol fumarate

Bisoprolol fumarate is a synthetic, cardioselective beta-1 adrenergic receptor blocker belonging to the aminoxypropanol class. It is supplied as a white to off-white crystalline powder, manufactured under cGMP conditions and tested to meet or exceed current pharmacopoeial standards (USP/EP).

As a highly selective beta-1 antagonist, bisoprolol fumarate is a cornerstone API for the treatment of hypertension, chronic stable angina, and heart failure. Its balanced lipophilicity and long half-life make it suitable for once-daily dosing, and it remains a preferred choice among healthcare professionals for cardiovascular management.

Product Highlights

  • High purity: ≥98.0% assay, with tight control on related substances and residual solvents.
  • Regulatory support: Available with DMF (Type II) and CEP, suitable for ANDA and generic filings.
  • Stable supply: Commercial-scale production with a current capacity of 20 metric tons per year.
  • Quality assurance: Each batch is fully traceable, with full documentation and retained samples.
  • Competitive pricing: Direct from manufacturer, offering cost advantages for bulk orders.

Applications

  • Treatment of essential hypertension, either as monotherapy or in combination with other antihypertensives.
  • Management of chronic stable angina pectoris.
  • Adjunct therapy in stable chronic heart failure with reduced ejection fraction.
  • Formulation of immediate-release and fixed-dose combination tablets.
  • Research on beta-adrenergic receptor pharmacology and cardiovascular therapeutics.

Specifications

Parameter Specification
Assay (HPLC, dried basis) 98.0% – 102.0%
Appearance White to off-white crystalline powder
Identification IR and HPLC retention time match reference standard
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
Heavy Metals ≤ 10 ppm
Related Substances Each impurity ≤ 0.5%, total ≤ 1.0%

Ordering & Supply

  • Packaging: 25 kg net in fiber drum with double polyethylene liner; custom packaging available upon request.
  • MOQ: 1 kg for trial orders; 25 kg for commercial orders.
  • Lead time: 3-5 business days (stock items)
  • Documentation: COA, MSDS, TDS, and regulatory support (DMF, CEP) provided with each shipment.

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