Technical Data Sheet OH
meta-Cresol BP, Ph.Eur., USP, CDMF
CH3
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
Key Product Attributes
IP
Pharmacopeia Status
: BP, Ph.Eur., USP, CDMF
• Manufacturing and packing under GMP environment
CAS No.
: 108-39-4
• Low Endotoxin suitable for parenteral application
EC No.
: 203-577-9
• Control of sub-visible particles
Molecular Formula
: C7H8O
• Control of Peroxide
Molecular Mass
: 108.14g/mol
• Control of residual solvent
Marketed Formulation • Methotrexate-human serum albumin injection • Insulin detemir injection • Albiglutide injection and more…
Pack Mode 500 ml and 1 Litre in glass bottles
DMF (Drug Master File) CDMF registered product (CDE # F20190000234)
Quality and Regulatory Support • GMP and ISO certification
Stability and Storage Conditions
• EXCiPACT certification
meta-Cresol and aqueous cresol solutions darken in colour
• Nitrosamine impurity risk assessment
with age and on exposure to air and light. They should be
• Elemental impurity risk assessment
stored in a well-closed container, protected from light, in a
• Residual solvent declaration
cool and dry place.
• Genotoxic impurity declaration • Vendor questionnaire and site audit • CMC documentation
Safety and Handling Information
• Regulatory queries
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.