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NITROGLYCERIN

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Nitroglycerin (Glycerol Trinitrate) is a rapid-acting vasodilator and nitric-oxide donor used clinically for the treatment and prevention of angina pectoris, acute coronary syndrome adjunct therapy, and in some acute decompensated heart-failure settings. In pharmaceutical manufacture it is supplied as a high-purity, pharmacopeial-grade active supplied for use in sublingual sprays, sublingual tablets/films, transdermal patches/ointments, and IV formulations (when formulated appropriately by licensed manufacturers).

Bluepill Express supplies pharmaceutical-grade Nitroglycerin API produced, handled and tested under WHO-GMP / cGMP / ISO quality systems with full batch documentation (COA, MSDS, TDS) suitable for regulated markets. Product is controlled for assay, residual solvents, impurities and stability to ensure safe, reliable performance in finished dosage forms.

Therapeutic applications

  • Acute relief of angina pectoris (sublingual formulations)
  • Prophylaxis of angina (sustained-release / transdermal systems)
  • Adjunct therapy in certain acute ischemic episodes and acute heart failure (parenteral forms)
  • Component in compounded topical/ointment preparations for local vasodilation (where licensed)

Mechanism of action

Nitroglycerin is converted in vascular smooth muscle to nitric oxide (NO) or NO-related species that activate guanylate cyclase, increasing cGMP levels. This causes smooth muscle relaxation and vasodilation, predominantly venodilation at therapeutic doses, reducing preload and myocardial oxygen demand.

Key technical specifications (typical pharmacopeial-grade)

  • Chemical name: Glyceryl trinitrate (Nitroglycerin)
  • Synonyms: Glyceryl trinitrate; NG; GTN
  • Molecular formula: C₃H₅N₃O₉
  • Molecular weight: 227.09 g·mol⁻¹
  • CAS number: 55-63-0
  • Appearance: Pale yellow to amber, viscous oily liquid (pharmaceutical batches may be stabilized in solution).
  • Assay (on dried basis): typically ≥ 98.0% (specification to be confirmed per buyer/pharmacopeia)
  • Identification: IR, HPLC, and related spectroscopic tests per pharmacopeial methods
  • Loss on drying / water content: per specification (controlled)
  • Related substances / impurities: within pharmacopeial limits (individual and total impurities specified in COA)
  • Solubility: freely soluble in ethanol, chloroform, ether; practically insoluble in water (formulation into aqueous systems requires appropriate solubilizers or microemulsion/solution approaches).
  • Physical stability: sensitive to heat, shock and light; batches are stabilized, tested and stored under controlled conditions.
  • Storage conditions: store in a cool, dry place below 25°C, protected from light and heat, in original tightly closed, labeled containers. Follow local regulations and MSDS for transport and storage.

Important safety note: Nitroglycerin is a regulated substance with both pharmaceutical uses and hazardous properties; handling, packaging, storage and transport must comply with applicable chemical safety and transport regulations. Refer to the MSDS and local authorities for hazard classification, transport restrictions and emergency procedures.

Pharmacopoeial & regulatory compliance

  • Standards: Manufactured to meet relevant pharmacopeial requirements (IP / BP / USP / EP) as agreed with purchaser.
  • Quality systems: WHO-GMP, ISO 9001:2015, cGMP manufacturing and QC testing.
  • Documentation: Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), Stability data; DMF available upon request (subject to contractual agreement and regulatory rules).
  • Testing methods: HPLC for assay and impurities, IR for identity, GC for residual solvents, appropriate microbial and heavy-metal testing.

Formulation & dosage form notes (for finished-product manufacturers)

  • Supplied API is suitable for licensed pharmaceutical manufacturers to develop:
    • Sublingual sprays and tablets/film strips (rapid onset)
    • Transdermal patches or ointments (sustained delivery)
    • Parenteral preparations (specialized sterile formulations; requires aseptic manufacture and validated compatibility)
  • Final dosage form design must consider nitroglycerin’s volatility, sensitivity to heat/light, and potential for dose variability — formulations commonly use stabilized solutions, appropriate excipients, and specialized packaging.

Packaging & typical export presentation

  • Packaging: Amber/opaque containers and inner liners to protect from light; multiple containment layers. Typical options: 1 kg, 5 kg, 10 kg, 25 kg in approved HDPE/metal drums with double poly liners — final packaging and labeling per purchaser/regulatory needs.
  • Labeling: Product name, strength, batch number, manufacturing & expiry dates, storage instructions, hazard statements, and handling precautions.
  • Shelf life: Typically up to 24–36 months under recommended storage; shelf-life validated by stability studies and provided with COA.

Safety, handling & transport (high-level guidance)

  • Personnel protection: use appropriate PPE (gloves, eye protection); avoid inhalation and skin contact.
  • Avoid conditions that promote decomposition: heat, open flame, friction, shock and light.
  • Transport & regulatory: Nitroglycerin is subject to hazardous-materials and controlled-substance rules in many jurisdictions — exporters and importers must comply with local transport (ADR/IMDG/IATA) and regulatory requirements. Bluepill Express provides MSDS and shipping documentation; buyers must ensure correct classification and permits prior to shipment.
    (Note: operational or procedural instructions that would facilitate misuse, synthesis, or explosive use are intentionally omitted.)

Advantages of Bluepill Express Nitroglycerin API

  • Pharmaceutical-grade API produced under WHO-GMP / cGMP
  • Rigorous QC: HPLC-assayed, impurity-controlled batches with full documentation
  • Stabilized and supplied in formulation-ready presentation for sublingual, topical and parenteral manufacturing
  • Regulatory support (COA, MSDS, TDS, stability data); DMF support options

Applications for procurement teams

  • Ideal for finished-dosage manufacturers producing sublingual sprays/films, transdermal patches, ointments or injectable vasodilator preparations (manufacturers must hold required licenses).
  • Bulk supply for licensed pharmaceutical formulators with validated containment and handling systems.

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