Bisoprolol Fumarate

Bisoprolol Fumarate

Tên sản phẩm Bisoprolol Fumarate
Số CAS 104344-23-2
Công thức phân tử C18H31NO4 · ½ C4H4O4
Trọng lượng phân tử 766.96 g/mol (as fumarate salt)
Hình thức Bột tinh thể màu trắng đến trắng ngà
Phương pháp phân tích (HPLC) 98.0% – 102.0% (on dried basis)
Mất mát khi sấy khô ≤ 0,5%
Hàm lượng tro sau khi đốt ≤ 0,1%
Kim loại nặng ≤ 10 ppm
Độ hòa tan Sparingly soluble in water, freely soluble in methanol, slightly soluble in ethanol
Gói 25 kg net in fiber drum with double polyethylene liner

Bisoprolol Fumarate Structure

Từ đồng nghĩa: 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.
  • Giá cả cạnh tranh: Direct from manufacturer, offering cost advantages for bulk orders.

Ứng dụng

  • 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.

Thông số kỹ thuật

Tham số Thông số kỹ thuật
Assay (HPLC, dried basis) 98.0% – 102.0%
Hình thức Bột tinh thể màu trắng đến trắng ngà
Xác định IR and HPLC retention time match reference standard
Mất mát khi sấy khô ≤ 0,5%
Hàm lượng tro sau khi đốt ≤ 0,1%
Kim loại nặng ≤ 10 ppm
Các chất liên quan Each impurity ≤ 0.5%, total ≤ 1.0%

Ordering & Supply

  • Bao bì: 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.
  • Thời gian thực hiện: 3-5 business days (stock items)
  • Tài liệu hướng dẫn: COA, MSDS, TDS, and regulatory support (DMF, CEP) provided with each shipment.

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