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Rabat 29/11/2007 Quality Assurance and Safety: Medicines World Health Organization
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2. Special features
3. Example of a monograph 4. WHOs strategy in QC 5. WHOs related activities
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WHO Procedure for the preparation of drug Quality Control specifications (1) ..or why it takes so long.
Preliminary consultation and drafting
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WHO Procedure for the preparation of drug Quality Control specifications (2)
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Type of monographs
Drug substances
Excipients
Finished dosage forms General methods and requirements: oral dosage forms, e.g. tablets dissolution testing
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More to come, first supplement in preparation to cover: New monographs for ARVs, TB and Malaria medicines, Revision of others, e.g. to include dissolution tests For pre-information visit the WHO web site:
http://www.who.int/medicines/publications/pharmacopoeia/overview/
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ARVs/finished products: - nelfinavir mesilate tablets, nelfinavir mesilate oral powder, and - saquinavir mesilate capsules fixed-dose antituberculosis medicines: - rifampicin tablets, - rifampicin capsules, - rifampicin + isoniazid tablets, rifampicin + isoniazid + pyrazinamide + ethambutol HCl tablets, - isoniazid + ethambutol HCl tablets, - rifampicin + isoniazid + pyrazinamide tablets
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Doxycycline hyclate capsules (new monograph) Doxycycline hyclate tablets (revision) Doxycycline hyclate (revision)
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Oral liquids
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Basic tests (identification) Screening tests (TLC) The International Pharmacopoeia International reference materials (ICRS and IR reference spectra)
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collaboration Ph.Eur. USP, JP, IP, Chinese Pharmacopoeia, Brazilian Pharmacopoeia ... collaboration with manufacturers links with WHO-UNICEF project on prequalification of suppliers for HIV drugs
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C36H47N5O4,H2O4S Relative molecular mass. 711.9 Chemical name. (2S)-1-[(2S,4R)-4-benzyl-2-hydroxy-5[[(1S,2R)-2-hydroxy-2,3-dihydro-1H-inden-1-yl] amino]-5-oxopentyl]-N-(1,1-dimethylethyl)-4-(pyridin-3-ylmethyl) piperazine-2-carboxamide sulfate; CAS Reg. No. 157810-81-6.
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Maintain the temperature of the column at 30C for 7 min, then raise the temperature at a rate of 35C per min to 180C and maintain for 10 min, maintaining the temperature of the injection port at 140C and that of the flame ionization detector at 250C.
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The test is not valid unless the relative standard deviation on the areas of the peaks obtained from the test solutions is not more than 5%.
Calculate the ethanol content by using the results obtained with the test solution and with the reference solutions; the ethanol content is not less than 50 mg/g and not more than 80 mg/g.
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Prepare the following solutions. For solution (1) use 2.0 mg of the test substance per ml. For solution (2) dilute a suitable volume of solution (1) to obtain a concentration equivalent to 2 g of Indinavir sulfate per ml.
For the system suitability test: prepare solution (3) using 2 ml of solution (1) and 2 ml of sulfuric acid (190 g/l), heat carefully in a boiling water bath
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Primary reference standard Linked to Ph.Int. Price for ICRS US$ 70 Includes: - Directions for use and - Certificate of analysis Monitoring and on-going stability testing Can be used for tests and analysis not included in Ph.Int.
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WHO COLLABORATING CENTRE FOR CHEMICAL REFERENCE SUBSTANCES in Sweden 69 International Infrared Reference Spectra Linked to Ph.Int.
100,0
W1 0 52 3 2 T
90 80 70
IR-spectrum of lamivudine
20 10 0,0 4000,0 3600 3200 2800 2400 2000 1800 1600 cm-1 1400 1200 1000 800 600 400,0
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4-Epitetracycline hydrochloride, Control No 306098, can be considered suitable as International Chemical Reference Substance for the intended purpose.
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3. Specifications should be used in a comprehensive way, i.e. including all tests listed
4. Specifications should be used intelligently, there is no guarantee that all (possible and impossible) impurities and alterations are covered!
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3. Collaboration with manufacturers around the world, especially for new projects
4. Close collaboration with WHO Member States, Drug Regulatory Authorities
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