Swapproop is engaged in the manufacturing and supply of Pregnenolone API in India, supporting pharmaceutical, healthcare, research, and steroid-hormone-related applications with quality-focused production and analytical control. Pregnenolone, also known as 5-Pregnenolone or 3β-Hydroxypregn-5-en-20-one, is a C21 steroid compound identified by CAS No. 145-13-1 and molecular formula C₂₁H₃₂O₂. Its molecular weight is approximately 316.48 g/mol.
As a steroid precursor, Pregnenolone is associated with the biosynthetic pathways of several steroid hormones, including progestogens, androgens, estrogens, glucocorticoids, and mineralocorticoids.
Swapproop focuses on consistent quality, controlled manufacturing processes, analytical testing, documentation, and batch-to-batch traceability for Pregnenolone API requirements.
Pregnenolone is a naturally occurring C21 steroid and an important intermediate in steroid biosynthesis. It is chemically described as 3β-Hydroxypregn-5-en-20-one. The compound contains a hydroxyl group and ketone functionality within its steroid structure.
Pregnenolone is a steroidal compound derived biosynthetically from cholesterol. It serves as a precursor or metabolic intermediate in the formation of several classes of steroid hormones. Its defined stereochemistry, molecular structure, and analytical characteristics make identity and purity testing important during pharmaceutical-grade production.
Commercial analytical references describe Pregnenolone as a white to almost white powder or crystalline material. TCI reports a melting-point specification of 187–192°C, while the NIST and PubChem records provide the established chemical identity and molecular characteristics.
Pregnenolone is primarily important as a steroid precursor and pharmaceutical/research intermediate. Its significance is associated with steroid biosynthesis and the production or study of downstream steroid compounds.
Potential industrial and pharmaceutical applications include:
The specific use, regulatory classification, and applicable quality requirements depend on the intended finished product and market.
Quality control is an important part of Pregnenolone API manufacturing. Analytical evaluation can include identity, assay/purity, related substances, moisture, residue, elemental impurities, optical rotation, melting point, and other tests defined by the applicable customer or regulatory specification.
Common analytical techniques for Pregnenolone include HPLC/GC, IR, NMR, mass spectrometry, melting-point determination, and optical rotation. TCI specifies GC purity of minimum 98.0%, melting point 187–192°C, and specific rotation +26.0° to +29.0° under its stated analytical conditions.
For pharmaceutical applications, the final release specification should be based on the applicable registered product specification, customer requirements, and regulatory requirements rather than assuming that a research-grade specification is a universal pharmacopoeial limit.
Swapproop provides Pregnenolone API manufacturing in India with an emphasis on controlled processes, analytical quality, documentation, and reliable batch consistency.
Our approach to Pregnenolone API production includes:
Pregnenolone API can be evaluated according to the requirements of the intended pharmaceutical application and applicable customer specifications.
Pregnenolone should be stored in a tightly closed container, protected from excessive heat, moisture, light, and unsuitable environmental conditions.
Commercial chemical data recommend storing Pregnenolone in a cool and dark environment, with TCI specifying a recommended temperature below 15°C for its product and recommending storage under inert gas because the material is identified as air-sensitive.
Packaging configuration can be selected according to quantity, transportation requirements, and customer specifications.
Depending on the product requirement and applicable supply arrangement, documentation may include:
Choosing a reliable Pregnenolone API Manufacturer in India is important for maintaining consistent quality and dependable pharmaceutical manufacturing operations.
Swapproop focuses on:
With a focus on quality and consistency, Swapproop aims to support customers requiring Pregnenolone API from India for pharmaceutical, research, and steroid-intermediate applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Specific Rotation | +26.0° to +29.0° |
| Melting Point | 187–192°C |
| Solubility | Soluble in chloroform; practically insoluble in water |