Benzyl Benzoate

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

  • Fulvestrant injection
  • Progesterone injection
  • Estradiol injection
  • Testosterone undecanoate depot (injection) & many more

Quality and Regulatory Support

  • GMP and ISO certification
  • EXCiPACT certification
  • Nitrosamine impurity risk assessment
  • Elemental impurity risk assessment
  • Residual solvent declaration
  • Genotoxic impurity declaration
  • Vendor questionnaire and site audit
  • CMC documentation
  • Regulatory queries

Key Product Attributes

  • Manufacturing and packing under GMP environment
  • Low Endotoxin suitable for parenteral application
  • Control of TAMC & TYMC
  • Control of pathogens
  • Control of sub-visible particles

Pack Mode

  • 500 ml, 1 Litre, 2.5 Litre glass bottle
  • 25 Litre plastic jerry can

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.

COA Product Catalogues Product Search Parenteral Applications
COA Product Catalogues Product Search Parenteral Applications