Tetrandrine API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Tetrandrine API is a naturally occurring bisbenzylisoquinoline alkaloid associated with the plant Stephania tetrandra. It belongs to the isoquinoline alkaloid class and has been investigated for calcium-channel modulation, anti-inflammatory, immunomodulatory and other pharmacological activities.

Tetrandrine is chemically distinct from Tetrandrine Hydrochloride and Tetrandrine Dihydrochloride. This page refers specifically to the free-base Tetrandrine API, CAS 518-34-3. The hydrochloride salt has a different molecular formula and molecular weight and should not be mixed with the free-base specification.

Chemical & Pharmaceutical Profile

ParameterDetails
Product NameTetrandrine
API CategoryNatural Alkaloid API
Chemical ClassBisbenzylisoquinoline Alkaloid
CAS No.518-34-3
Molecular FormulaC₃₈H₄₂N₂O₆
Molecular Weight622.7 g/mol
PubChem CID73078
SynonymsD-Tetrandrine, (+)-Tetrandrine, Tetrandrin
SourceStephania tetrandra and related botanical sources
Therapeutic/Research CategoryCalcium-channel modulator / anti-inflammatory and immunomodulatory research API

PubChem identifies Tetrandrine as C₃₈H₄₂N₂O₆ with a molecular weight of 622.7 g/mol and CAS 518-34-3.

Pharmaceutical Applications

Tetrandrine has been investigated in pharmaceutical and biomedical research for several biological activities, including:

  • Calcium-channel modulation
  • Anti-inflammatory activity
  • Immunomodulatory activity
  • Antiproliferative research
  • Oxidative-stress and free-radical research
  • Cardiovascular pharmacology research
  • Pulmonary and inflammatory disease research

Tetrandrine has been described as a non-selective calcium-channel inhibitor and has been studied for immunosuppressive, antiproliferative and free-radical-scavenging effects.

Mechanism of Action

Tetrandrine is a bisbenzylisoquinoline alkaloid that has been reported to interfere with calcium-channel activity. Changes in intracellular calcium signaling can influence processes including cellular proliferation, inflammatory signaling and smooth-muscle activity.

Because Tetrandrine has multiple reported pharmacological activities, its mechanism can vary depending on the biological system and research model.

Quality & Analytical Testing

For pharmaceutical-grade Tetrandrine API, quality control should include appropriate analytical testing for identity, assay, purity and physicochemical characteristics.

Typical analytical testing may include:

  • FTIR/IR identification
  • HPLC identification
  • HPLC assay
  • Related substances
  • Individual impurities
  • Total impurities
  • Residual solvents
  • Water content
  • Residue on ignition/sulphated ash
  • Elemental impurities
  • Chromatographic purity
  • Optical characteristics where applicable

Numerical acceptance criteria should be taken from the applicable approved specification or current validated product specification rather than transferred from another Tetrandrine salt.

Important specification note: I could verify the exact identity values for Tetrandrine, but I could not verify a current authoritative public pharmacopoeial monograph providing universal numerical assay and impurity limits specifically for the free-base Tetrandrine API. Therefore, I recommend not inserting an invented assay such as 98.0–102.0% or 99.0% minimum into your CMS. PubChem confirms the product-specific identity data.

Tetrandrine API Manufacturer in India

Swapnroop Drugs & Pharmaceuticals provides quality-focused pharmaceutical API manufacturing capabilities for customers requiring Tetrandrine for pharmaceutical, formulation and research applications.

As a Tetrandrine API Manufacturer in India, Swapnroop focuses on:

  • Controlled manufacturing processes
  • Consistent API quality
  • Analytical testing
  • Batch-to-batch consistency
  • Pharmaceutical documentation
  • Suitable API packaging
  • Customer-specific technical documentation
  • Regulatory-oriented quality systems

Packaging & Storage

Tetrandrine API should be packed in suitable pharmaceutical-grade packaging to protect the material from moisture, light and environmental contamination.

Packaging

  • Well-closed primary container
  • Moisture-protective packaging
  • Light protection where required
  • Proper batch identification
  • Appropriate secondary packaging

Storage

Store in a well-closed container under validated storage conditions, protected from excessive moisture, heat and direct light.

Documentation

Documentation can include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • Technical Data Sheet
  • Batch analytical documentation
  • Stability information, where applicable
  • Packaging information
  • Regulatory documentation, where applicable

Why Choose Swapnroop for Tetrandrine API?

  • Quality-focused API manufacturing
  • Product-specific analytical testing
  • Consistent manufacturing processes
  • Pharmaceutical documentation support
  • India-based API manufacturing
  • Technical support for formulation requirements
  • Suitable pharmaceutical-grade packaging

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Get Bulk Quote via WhatsApp