GAZETTE NOTICE NO. 5607

IT IS notified for general information that the fees specified in the third and fourth columns of the Schedule, shall be payable to the National Quality Control Laboratory for the tests respectively specified in the second column, with effect from the 30th April, 2023. SCHEDULE NQCL HEALTH PRODUCTS AND TECHNOLOGIES TESTING FEES Test USd* KSh. Wet Chemistry 1. Uniformity of Weight/Volume • Tablets/ Pessaries/ Suppositories 25.00 2,000.00 • Capsules/Vials/Bottles/Ampoules 50.00 4,000.00 2. Uniformity of Content • By HPLC 335.00 30,000.00 • By UV Spectrometry 195.00 17,000.00 • By Titrimetry 235.00 21,000.00 3. Identification Only • By Colour Change/Chemical Reaction 55.00 5,000.00 • By HPLC 395.00 26,000.00 • By FTIR 170.00 15,000.00 • By TLC 115.00 10,000.00 • By UV/Vis Spectrometry 170.00 15,000.00 • By Titrimetry 205.00 18,000.00 4. Identification followed by: • Assay using HPLC 350.00 31,000.00 • Assay using UV/Vis spectrometry 260.00 23,000.00 • Assay using Titrimetry 325.00 29,000.00 5. Dissolution and Identification by: • HPLC/UV-Vis Spectrometry/Titrimetry 360.00 32,000.00 Each additional component and/or stage 170.00 15,000.00 6. Assay by: • HPLC 290.00 26,000.00 • UV-Vis Spectrometry 170.00 15,000.00 • Titrimetry 205.00 18,000.00 • Atomic Absorption/Emission Spectrometry (per element) 350.00 31,000.00 Multicomponent dosage (each additional component) (For dry syrups/suspensions, see note below) 135.00 12,000.00 7. Related Substances/Impurities 150.00 13,000.00 8. Determination of Water Content 205.00 18,000.00 9. Loss on Drying 90.00 8,000.00 10. Determination of pH 25.00 2,000.00 28th April, 2023 THE KENYA GAZETTE Test USd* KSh. 11. Determination of Melting Point 35.00 3,000.00 12. Friability 50.00 4,000.00 13. Disintegration 50.00 4,000.00 14. Optical Rotation 50.00 4,000.00 Note: For dry syrups assayed both when freshly reconstituted and after x days, cost the additional assay as an additional component for each ingredient quantified in this manner Biological Analysis 15. Sterility Test 615.00 55,000.00 16. Microbial Contamination of Non-sterile Products 290.00 26,000.00 17. Bacterial Endotoxin Test (LAL) 425.00 38,000.00 18. Microbial Assay 335.00 30,000.00 19. Preservative Efficacy 315.00 28,000.00 Medical Devices 20. Male Latex Condoms - Total Lubricant Test 435.00 39,000.00 21. Male Latex Condoms - Inflation (Burst volume/pressure) Test 390.00 35,000.00 22. Male Latex Condoms - Freedom from holes (Conductivity) Test 335.00 30,000.00 23. Male Latex Condoms - Dimension (Thickness) Test 115.00 10,000.00 24. Male Latex Condoms - Dimension (Length) Test 115.00 10,000.00 25. Male Latex Condoms - Dimension (Width) Test 115.00 10,000.00 26. Visual Leak Test 170.00 15,000.00 27. Wet Package Integrity Test 170.00 15,000.00 28. Surgical Latex Gloves - Dimensions (Length) Test 115.00 10,000.00 29. Surgical Latex Gloves - Dimensions (Width) Test 115.00 10,000.00 30. Surgical Latex Gloves - Dimensions (Thickness) Test 115.00 10,000.00 31. Syringe Function Test 105.00 9,000.00 32. Syringe Package Integrity 35.00 3,000.00 33. Syringe Air Leak Test 105.00 9,000.00 34. Syringe Determination of pH 80.00 7,000.00 35. Hypodermic Needle Penetration Test 135.00 12,000.00 36. Hypodermic Needle Patency of Lumen Test 105.00 9,000.00 37. Hypodermic Needle Appearance of Needle Point Test 105.00 9,000.00 Dated the 6th April, 2023. MATILU MWAU, Ag. Director-General, MR/5166343 National Quality Control Laboratory.