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Pharmacopeial 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.

The four major pharmacopeias in use world-wide today are:

  1. The International Pharmacopeia (IP) – “official” and primarily used in the developing nations
  2. The British Pharmacopeia (BP) – “official” and primarily used in the 54 member countries of the British Commonwealth
  3. The United States Pharmacopeia (USP) – “official” and primarily used in North America and in 27 other countries
  4. The European Pharmacopeia (Ph. Eur.) – “official” and primarily used in the 26 countries which are member states of the Council of Europe

Tepnel offers testing from the four major pharmacopeias listed above, BP, USP and Ph.Eur.  We also offer testing from the Japanese Pharmacopeia for testing specific to the Japanese marketplace.

 

Equipment available at Tepnel to undertake pharmacopeial testing:

 

pH meters Balances (4, 5 and 6 Fig.) gas chromatographs (FID,
HPLC (detectors?) UPLC (detectors?) LC-MSMS
Infrared spectrophotometers Ultra violet/visible spectrophotometers Karl Fischer moisture titrators
General titration apparatus Vacuum ovens Melting-point apparatus
Thin-layer chromatography apparatus Polarimeters Refractometers
Viscometers Muffle furnaces.

 

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:

Sections in Raw Material Testing Service

All Raw Material Testing Service

Additional Resources

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