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Refrigerated storage for Ergometrine & Methylergometrine injection

Friday, 27th January 2017

                                                                                   CIRCULAR NO.001/QM/2017

                                                           To: All importers and manufacturers of pharmaceutical products

                                          REFRIGERATED STORAGE FOR ERGOMETRINE & METHYLERGOMETINE INJECTION                         

I have the duty to inform you that the National Drug Authority following careful consideration of all available information and evidence has directed that, with immediate effect, all injectable ergometrine and methylergometrine to be imported into Uganda should be labeled for storage under refrigeration between 2-8oC.

You are advised to check the available stock that was not previously stored under refrigeration, to determine if the ergometrine or methylergometrine is still of good quality. A simple check on the quality can be done by comparing the colour of the product and clear water in glass tubes. There is a strong correlation between the colour of the solution of (rnethy) ergometrine and its level of active ingredient (r=0.8487 for ergometrine, r=0.8730 for methylergometrine). Any discolouration of (methyl)ergometrine of good initial quality which makes the solution different from water implies, with a sensitivity of 97-100%, that the level of active ingredient is below USP/BP standards of 90% of the stated content, and should not be used.

The good stock should then be transferred to a storage between 2-8oC.

We highly appreciate your usual cooperation.