Nandrolone API Manufacturer in India

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Nandrolone API

Nandrolone is a synthetic anabolic-androgenic steroid (AAS) and a derivative of testosterone. It is a 19-nor steroid characterized by the absence of the methyl group at the C-19 position of the steroid nucleus.

Nandrolone has anabolic and androgenic activity and is used as an active pharmaceutical ingredient in the development and manufacture of certain steroid-based pharmaceutical formulations. Nandrolone is also an important reference compound in pharmaceutical, analytical and steroid research.

Nandrolone API Manufacturer in India

Nandrolone is a well-characterized steroidal pharmaceutical API with applications in pharmaceutical formulation development, analytical testing and research involving anabolic-androgenic steroid compounds.

Important API quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable pharmaceutical quality parameters.

Chemical Information

CAS Number: 434-22-0

Molecular Formula: C18H26O2

Molecular Weight: 274.40 g/mol

Chemical Name: 17β-Hydroxyestra-4-en-3-one

IUPAC Name: (8S,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one

Drug Class: Anabolic-Androgenic Steroid

Therapeutic Class: Anabolic Steroid

Therapeutic Area: Endocrinology / Musculoskeletal

Molecule Type: Synthetic Small Molecule

Mechanism of Action

Nandrolone exerts its pharmacological effects primarily through interaction with the androgen receptor, a nuclear steroid hormone receptor.

Its activity includes:

  • Binding to androgen receptors
  • Regulation of androgen-responsive gene expression
  • Promotion of anabolic protein synthesis
  • Effects on skeletal muscle and other androgen-responsive tissues
  • Promotion of nitrogen retention and protein metabolism
  • Androgenic effects in susceptible tissues

Nandrolone is a 19-nor testosterone derivative and has a different androgenic/anabolic activity profile from testosterone.

Pharmaceutical Applications

Nandrolone API is relevant to:

  • Anabolic steroid formulation development
  • Pharmaceutical API manufacturing
  • Steroid drug development
  • Endocrine and hormonal research
  • Musculoskeletal pharmaceutical research
  • Analytical reference testing
  • Steroid pharmacology research
  • Pharmaceutical research and development
  • Quality-control and analytical testing

Nandrolone has historically been used in certain pharmaceutical formulations for conditions involving anemia and muscle or tissue wasting, depending on the specific nandrolone ester, formulation and regulatory jurisdiction.

Nandrolone Ester Applications

Nandrolone itself should be distinguished from its pharmaceutical esters.

Important nandrolone derivatives include:

  • Nandrolone decanoate
  • Nandrolone phenylpropionate

These esterified forms have different chemical identities, CAS numbers, molecular weights and pharmacokinetic properties.

Therefore, a Nandrolone API page should not use the specifications of Nandrolone Decanoate or Nandrolone Phenylpropionate.

Physical Characteristics

Nandrolone is generally described as a white or almost white crystalline powder. It is practically insoluble in water and has greater solubility in various organic solvents.

Its physical characteristics, particle properties and crystalline form should be controlled according to the applicable pharmaceutical specification.

Manufacturing Process

A controlled Nandrolone API manufacturing process may involve:

  1. Qualification of starting materials
  2. Preparation of appropriate steroidal intermediates
  3. Controlled chemical transformations
  4. Introduction or modification of functional groups
  5. Reduction or oxidation steps where applicable
  6. Reaction monitoring
  7. Purification
  8. Crystallization
  9. Filtration and washing
  10. Controlled drying
  11. Milling, where required
  12. Final analytical testing
  13. GMP-compliant packaging

Quality Control Testing

Typical Nandrolone API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Steroidal impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Melting point
  • Specific optical rotation
  • Particle-size distribution, where applicable
  • Stability testing

Storage

Store Nandrolone API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Final storage conditions should be established according to validated stability data and the applicable API specification.

Pharmaceutical Research

Nandrolone is relevant to research involving:

  • Anabolic-androgenic steroids
  • Androgen receptor pharmacology
  • Steroid chemistry
  • Protein metabolism
  • Anabolic activity
  • Endocrine pharmacology
  • Steroid drug development
  • Pharmaceutical formulation development
  • Analytical steroid testing
  • Hormonal research

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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