‘Ada. Off: Rogd. Office & Works : Umax Hse, Plot No.2, woe RSC Tae Secure MiD.6-Torapu, Noar Suoehans Hospi, Chak, | Bosar-401 90 Kandivali (W), Mumbai - 400 067 Dist. Paighar, UNIMAX. Boro Prone: 02525661196 UNIMAX LABORATORIES PVT. LTD. ‘Telefax : 91-22-29676663 Email : brijesh@unimax.co.in MFGRS & EXPORTERS OF: Specialised API Products. Email: info@unimax.co.in CIN: U24110MH1985PTC035004 (Exclusively Cortico-Steriods) Date: 21/10/2021 DECLARATION / STATEMENT OF ELEMENTAL IMPURITIES No any heavy metal impurities of Class 1, 2A and Class 3 metals is intentionally added as well as the process risk evaluation study shows that there is no possibility of any contamination of these metals in finished drug substance in manufactured by Unimax Laboratories Pvi. Ltd. at current site. Three batches ‘were analyzed and evaluated as per ICH Q3D guideline for class 1, 2A and 3 metals. Based on study the total elemental impurity level from all sources in the drug product Betamethasone Dipropionate is found less than less than 30% of the Permissible limit as per ICH Q3D and also below 30% of General Pharmacopeial limit of !ppm. Hence additional controls are not requi Hence can be declared and certified that there has no risk of elemental impurity of class 1, 2A and 3 metals in Betamethasone Dipropionate final drug substance as a raw material for intended use for pharmaceutical product and routine release testing of heavy metal is not required as per ICH Q3D ‘guideline manufactured and supplied by Unimax Laboratories Pvt. Ltd. Cadmiun(Cd) 0.05 ppm 0.09 ppm | Not Detected Lead (Pb) 238 ppm 1.86 ppm 2.00 ppm Arsenie (inorganie\As) lemons BS Not Detected | Not Detected | Not Detected ‘Cobalt (Co) ‘Not Detected | Not Detected | Not Detected Vanadium (V) 0.09 ppm 0.04 ppm 0.05 ppm Nickel(N G02 ppm | Not Detected | Not Detected Copper (Cul 0.88 ppm 0.58 ppm 0.50 ppm “Antimony (Sb) NotDetecied | Not Detected | Not Detected Lithium (Li) 183 ppm 0.04 ppm (0.04 ppm Not Detected | Not Detected | Not Detected