Here is the updated, technically precise, and regulatory-compliant content for European Pharmacopoeia (Ph. Eur.) Grade Castor Oil.
I have structured this section to demonstrate Nova Industries’ capability to meet the stringent purity standards required for the European pharmaceutical market.
Castor Oil Eur. Ph. (European Pharmacopoeia)
Manufactured by Nova Industries
Nova Industries manufactures Castor Oil Eur. Ph., a premium pharmaceutical grade designed specifically for the European Union market. This product is produced under strict Good Manufacturing Practices (GMP) to comply with the current monograph of the European Pharmacopoeia (Ph. Eur.).
Unlike standard grades, the Eur. Ph. grade undergoes a specialized refining process—involving neutralization, earth bleaching, and high-vacuum deodorization—to ensure the removal of Free Fatty Acids, oxidation by-products, and specific absorbance-causing impurities.
1. Regulatory & Quality Significance
The European Pharmacopoeia sets some of the most rigorous standards for vegetable oils used in medicinal products. Nova Industries ensures:
- Specific Absorbance: A critical parameter in the Ph. Eur. monograph. Our oil is refined to ensure minimal light absorption at specific UV wavelengths, indicating the absence of oxidized compounds and conjugated dienes.
- Purity: The oil is free from foreign fatty acids and adulterants, verified via Gas Chromatography (GC) analysis of the methyl esters.
- Solvent Residue: Guaranteed to meet the limit for residual solvents (if solvent extraction is used in the preliminary stage), ensuring patient safety.
2. Pharmaceutical Applications
This grade is exclusively utilized for therapeutic and medicinal formulations within the EU.
- Soft Gelatin Capsules: Used as the primary fill ingredient or carrier for lipophilic Active Pharmaceutical Ingredients (APIs) in softgel capsules.
- Topical Dermatologicals: A key emollient in creams and ointments prescribed for skin disorders, where low acidity and high purity are required to prevent irritation.
- Excipient: Functions as a non-ionic surfactant and emulsifying agent in complex drug delivery systems.
3. Technical Specifications (Ph. Eur. Monograph)
Nova Industries provides a Certificate of Analysis (COA) with every shipment, confirming adherence to the following parameters:
| Parameter | Specification (Ph. Eur.) |
| Product Name | Castor Oil (Virgin / Refined) |
| Monograph | European Pharmacopoeia (Current Edition) |
| Appearance | Clear, nearly colorless or slightly yellow viscous liquid |
| Relative Density ($d_{20}^{20}$) | 0.952 – 0.965 |
| Refractive Index ($n_{D}^{20}$) | 1.477 – 1.481 |
| Optical Rotation | $+3.5^\circ$ to $+6.0^\circ$ |
| Acid Value | 0.8 Max (for Virgin) / 2.0 Max (Refined) |
| Peroxide Value | 5.0 Max (at time of release) |
| Specific Absorbance (at 269 nm) | 1.0 Max (Critical Ph. Eur. Limit) |
| Hydroxyl Value | 150 Minimum |
| Iodine Value | 82 – 90 |
| Saponification Value | 176 – 187 |
| Unsaponifiable Matter | 0.8% Max |
| Water Content | 0.3% Max |
| Impurity A (Ricinoleic Acid) | Complies with GC Profile |
Packaging & Export Logistics
Nova Industries ensures that the high purity of this grade is maintained during transit to Europe.
- Packaging: 190/200 Kg New Steel Drums (Epoxy Phenolic Lacquered) / 1000 L IBC Totes.
- Shelf Life: 24 Months (when stored in original sealed containers, protected from light).
- Documentation: Supplied with COA, MSDS, and TSE/BSE Free Declaration.
For Regulatory Documentation & Supply:
Nova Industries
Website: https://novaind.in/