Meta - Cresol

Meta-cresol is a colourless, viscous liquid that is sensitive to light and tends to darken on exposure to it. It is an intermediate in the production of many different chemicals, a preservative in dermal and parenteral pharmaceutical preparations as well as a solubilising agent. We supply and export high quality Meta-cresol which is manufactured and packed under GMP environment along with regulatory documentation including Nitrosamine and elemental impurities risk assessment documents for pharma applications. 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.

BP, Ph.Eur., USP, CDMF

Applications

meta-Cresol is widely used in the pharmaceutical industry for a variety of reasons which include:

  • As a preservative in Dermal, Parenteral pharmaceutical preparations
  • As a solubilising agent in Microsphere and other NDDS preparations

General Information

Pharmacopeia Status : BP, Ph.Eur., USP, CDMF

CAS No. : 108-39-4

EC No. : 203-577-9

Molecular Formula : C7H8O

Molecular Mass : 108.14g/mol

Marketed Formulation

  • Methotrexate-human serum albumin injection
  • Insulin detemir injection
  • Albiglutide injection and 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 sub-visible particles
  • Control of Peroxide
  • Control of residual solvent

Pack Mode

  • 500 ml and 1 Litre in glass bottles

DMF (Drug Master File)

CDMF registered product (CDE # F20190000234)

Pharmaceutical Specifications

Particulars Limit
Description Colourless, highly refractive liquid, becoming darker with age and on exposure to light. A saturated solution of it is neutral or only slightly acid to litmus (USP)
Description Solidified mass or clear liquid (BP,Ph.Eur)
Solubility Sparingly soluble in water, usually forming a cloudy solution; dissolves in solutions of fixed alkali hydroxides. Miscible with alcohol, with ether, and with glycerin (USP)
Solubility Sparingly soluble in water, miscible with ethanol (96%) and with methylene chloride (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)
Identification B (By GC Chromatogram) The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay (USP)
Relative density About 1.03 (BP, Ph.Eur)
Melting point About 11°C (BP, Ph.Eur)
Boiling point About 202°C (BP, Ph.Eur)
Appearance of Solution Freshly prepared solution should not more opalescent than reference suspension III and not more intensely coloured than reference solution BY 7 (BP, Ph.Eur)
Assay (By GC) 98.0% - 102.0% (USP)
Organic Impurities (Orthocresol) Not more than 0.5% (USP)
Related Substances: Impurity B (O-Cresol, cresol) Not more than 0.5% (BP, Ph.Eur)
Organic Impurities (Paracresol) Not more than 0.5% (USP)
Related Substances: Impurity C (p-Cresol) Not more than 0.5% (BP. Ph.Eur)
Organic Impurities (Any unspecified impurity) Not more than 0.1% (USP)
Related Substances: Any other impurity Not more than 0.1% (BP, Ph.Eur)
Organic Impurities (Total impurities) Not more than 1.0% (USP)
Related Substances: Total impurity Not more than 1.0% (BP, Ph.Eur)
Clarity of Solution A (By Chemical Test) A clear solution (USP)
Clarity of Solution B (By Chemical Test) A clear solution (USP)
Acidity Not more than 0.5 ml of 0.01 M sodium hydroxide is required to change the colour of the indicator to yellow. (BP, Ph.Eur)
Residue on Evaporation 0.1% max (BP, Ph.Eur)
Bacterial Endotoxins 0.5 EU/mg (In-house)
Peroxide Value Less than 5ppm (In-house)

Stability and Storage Conditionss

meta-Cresol and aqueous cresol solutions darken in colour with age and on exposure to air and light. They should be stored in a well-closed container, protected from light, in a cool and dry place.

Safety and Handling Information

Wear personal protective equipment. Keep away from open flame, hot surfaces and sources of ignition. Ensure adequate ventilation. Avoid contact with the eye, skin and clothing. Do not inhale vapours or ingest.

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