Bisoprolol Fumarate

Bisoprolol Fumarate

製品名 Bisoprolol Fumarate
CAS番号 104344-23-2
分子式 C18H31NO4 · ½ C4H4O4
分子量 766.96 g/mol (as fumarate salt)
外観 白色からオフホワイトの結晶性粉末
分析(HPLC) 98.0% – 102.0% (on dried basis)
乾燥減量 ≤ 0.5%
焼失残渣 ≤ 0.1%
重金属 10 ppm以下
溶解度 Sparingly soluble in water, freely soluble in methanol, slightly soluble in ethanol
パッケージ 25 kg net in fiber drum with double polyethylene liner

Bisoprolol Fumarate Structure

同義語: 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.

製品の特長

  • 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.
  • 競争力のある価格設定: Direct from manufacturer, offering cost advantages for bulk orders.

用途

  • 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.

仕様

パラメータ 仕様
Assay (HPLC, dried basis) 98.0% – 102.0%
外観 白色からオフホワイトの結晶性粉末
識別 IR and HPLC retention time match reference standard
乾燥減量 ≤ 0.5%
焼失残渣 ≤ 0.1%
重金属 10 ppm以下
関連物質 Each impurity ≤ 0.5%, total ≤ 1.0%

発注・調達

  • パッケージ: 25 kg net in fiber drum with double polyethylene liner; custom packaging available upon request.
  • 最小注文数量(MOQ): 1 kg for trial orders; 25 kg for commercial orders.
  • リードタイム: 3~5営業日(在庫品)
  • ドキュメント: COA, MSDS, TDS, and regulatory support (DMF, CEP) provided with each shipment.

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