Benzyl Benzoate is also known as benylic acid or benylate. It is a chemical that is found in many food products like lemons, pomes, etc. With some of the best resources coupled with experts who understand chemical preparations, we prepare superior quality Benzyl Benzoate. It is a clear, colourless, oily liquid that has a slight odour. It is used in different forms including microcapsules, microspheres, gel, cream and many other dosage forms etc. All our products are manufactured under the most stringent environment, health and safety standards. We comply with the Highest Quality Standards and are an ISO 9001:2015, 14001:2015, ISO 45001:2018, ISO/IEC 17025:2017, EXCiPACT and GMP certified company.
IP, BP, Ph.Eur., USP, CDMF
Applications
Benzyl benzoate is widely used as a pharmaceutical excipient in various formulations as a plasticizer, solubilizing agent and solvent. The preferred route of application is Parenteral (i.e., Microcapsules, Microspheres) and Topical (i.e. Gel, Cream) dosage forms.
General Information
Pharmacopeia Status : IP, BP, Ph.Eur., USP
CAS No : 120-51-4
EC No. : 204-402-9
Appearance/Description : Clear, colorless, oily liquid having a slight aromatic odor
Molecular Formula : C14 H12 O2
Molecular Mass : 212 g/mol
Marketed Formulations
Quality and Regulatory Support
Key Product Attributes
Pack Mode
DMF (Drug Master File)
CDMF registered product (CDE # F20190000461)
Pharmaceutical Specifications
| Particulars | Limit |
|---|---|
| Description | Clear, colorless, oily liquid having a slight aromatic odor (USP, CDMF, IP, BP, Ph.Eur) |
| Assay | 99.0% - 100.5% (USP, CDMF, IP, BP, Ph.Eur) |
| Solubility | Practically insoluble in water and glycerin. Miscible with alcohol, ether, methylene chloride and fatty and essential oils and chloroform (USP, CDMF, IP, BP, Ph.Eur) |
| Identification A (By IR) | IR Spectra of the sample should be concomitant with IR spectra of the corresponding standard (BP, Ph.Eur, USP, CDMF) |
| Identification B (By Chemical test) | Dried precipitate should melt between 121°C to 124°C (BP, Ph.Eur) |
| Limit of Aldehydes (As benzaldehyde) | NMT 0.05% (USP, CDMF) |
| Specific gravity, 25°C | 1.116 - 1.120 (USP, CDMF) |
| Relative density, 20°C | 1.113 - 1.118 (IP) |
| Relative density, 20°C | 1.118 - 1.122 (BP, Ph.Eur) |
| Congealing temperature | NLT 18.0°C (USP, CDMF) |
| Congealing temperature | Not below 17.0° C (IP) |
| Boiling point | About 320°C (BP, Ph.Eur) |
| Freezing point | Minimum 17.0°C (BP, Ph.Eur) |
| Refractive index,20° C | 1.568 - 1.570 (IP, BP, Ph.Eur, USP, CDMF) |
| Sulphated ash | NMT 0.1% (IP, BP, Ph.Eur) |
| Acidity | NMT 1.5 mL of 0.02N sodium hydroxide should be required to restore the pink color (USP, CDMF) |
| Acidity | Not more than 0.2 mL of 0.1M sodium hydroxide should be required to change the color of the indicator to pink (BP, Ph.Eur) |
| Total aerobic microbial count | NMT 100 cfu/ml (In-house) |
| Total combined yeast and molds count | NMT 10 cfu/ml (In-house) |
| Bacterial endotoxins | NMT 0.25 EU/ml (In-house) |
| E.coli | Absent/ml (In-house) |
| Salmonella | Absent/10ml (In-house) |
| Staphylococcus aureus | Absent/ml (In-house) |
| Pseud. aeruginosa | Absent/ml (In-house) |
| Purity (By GC) | NLT 99.8% (In-house) |
| Any individual impurity (By GC) | NMT 0.10% (In-house) |
Stability and Storage Conditions
Benzyl benzoate is stable when stored in tight, well-filled, light resistant containers. Exposure to excessive heat (above 40 °C) should be avoided.
Safety and Handling Information
Benzyl benzoate may be harmful if ingested, and is irritating to the skin, eyes, and mucous membranes. Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection, gloves, and a respirator are recommended. It is recommended that Benzyl benzoate is handled in a fume cupboard. Benzyl benzoate is flammable.
