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:
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
Quality and Regulatory Support
Key Product Attributes
Pack Mode
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.
