Pharmacopoeial Monographs
Pharmacopeias are authoritative treatises on drugs and preparations presenting information on their description, formulation, analytic composition, physical constants, main chemical properties used in identification, standards for strength, purity, and dosage, chemical tests for determining identity and purity, etc.
Tepnel offers testing from the four major pharmacopeias listed below, IP, BP, USP and Ph. Eur. We also offer testing from the Japanese Pharmacopeia for testing specific to the Japanese marketplace.
The four major pharmacopeias in use world-wide today are:
- The International Pharmacopeia (IP) – “official” and primarily used in the developing nations
- The British Pharmacopeia (BP) – “official” and primarily used in the 54 member countries of the British Commonwealth
- The United States Pharmacopeia (USP) – “official” and primarily used in North America and in 27 other countries
- The European Pharmacopeia (Ph. Eur.) – “official” and primarily used in the 26 countries which are member states of the Council of Europe
Equipment available at Tepnel to undertake pharmacopoeial testing:
- HPLC (UV, PDA, FLU, ELSD, MALS, RI, TUV, CAD, SQDMS)
- Infrared spectrophotometers
- General titration apparatus
- Thin-layer chromatography apparatus
- Viscometers
- pH meters
- UPLC (UV, PDA, FLU, ELSD, MALS, RI, TUV, CAD, SQDMS)
- Ultra violet/visible spectrophotometers
- Vacuum ovens
- Polarimeters
- Muffle furnaces
- Balances (4, 5 and 6 Figures after decimal point)
- Karl Fischer moisture titrators
- Melting-point apparatus
- Refractometers
- Gas chromatographs
- (GC-FID)
With the implementation of the ICH Q6A document, guidance was given on the harmonisation of specifications such that there was a confluence of specifications across different regions. A consequence of the ICH6A document has been the subsequent harmonisation of several compendial test chapters among the USP, JP and EP.
Tepnel undertakes harmonised testing as per the ICH guidance for:
- Residue on ignition/sulphated ash
- Extractable volume of parenteral preparations
- Particulate contamination: sub-visible particles
- Microbiological examination of non-sterile products: Microbial enumeration tests
- Microbiological examination of non-sterile products: Tests for specified microorganisms
- Microbiological examination of non-sterile products: Acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use
- Uniformity of dosage units
- Dissolution test
- Sterility chapter
- Tablet friability
- Polyacrylamide gel electrophoresis
- Capillary electrophoresis
- Analytical sieving
- Bulk density and tapped density of powders
- Bacterial endotoxins test
- Disintegration test
