Amlodipine Besylate

Synonimy: Amlodipine benzenesulfonate, Norvasc, Istin, Amlor, UK-4834011

Amlodipine Besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. It is a white to off-white crystalline powder, practically insoluble in water but freely soluble in organic solvents such as methanol and chloroform. The compound is manufactured under cGMP conditions and is available in pharmacopeial grades (USP/EP/BP) suitable for oral solid dosage forms.

As a long-acting antihypertensive, amlodipine besylate is a cornerstone in the management of hypertension and angina. Its high protein binding and slow hepatic metabolism allow for once-daily dosing, making it a preferred choice for both monotherapy and fixed-dose combinations. The API is widely used in tablet formulations, often co-formulated with agents like valsartan, olmesartan, or atorvastatin to enhance therapeutic outcomes.

Product Highlights

• High Purity: Assay 98.0%–102.0% (HPLC), meeting USP/EP/BP specifications.
• Regulatory Support: Full documentation including COA, MSDS, and TDS for regulatory filings.
• Stable Supply: Commercial-scale production with consistent batch-to-batch quality.
• Custom Packaging: Available in 25 kg drums, with options for smaller quantities.
• Technical Service: Dedicated support for formulation and compliance inquiries.

Zastosowania

• Hypertension management in adults and pediatric patients.
• Chronic stable angina and vasospastic angina.
• Fixed-dose combination products with ARBs, ACE inhibitors, or statins.
• Research on calcium channel modulation and cardiovascular therapies.

Dane techniczne

Ordering & Supply

• Opakowanie: 25 kg fiber drum with double polyethylene bags; custom packaging available.
• MOQ: 1 kg for pilot batches; 25 kg for commercial orders.
• Czas realizacji: 3–5 dni roboczych (towary dostępne w magazynie)
• Dokumentacja: COA, MSDS, TDS, and regulatory support provided.

Zapytanie ofertowe

• LyvBio Sp. z o.o. — E-mail: info@lyvbio.com