Fermenta Biotech Ltd. thi ‘Admin. & Regd. Office: h-1501. Thane-One, di’ Complex, Ghodbunder Road, “Mativada, Thane (W)-400 610, Mahaashira, dia Fax: +91 22 6798 0999 Tel: 491 22 67980800/888, Emil: fermenta@ fermentabiotech.com Cholecalciferol Ph. Eur. Impurities: List of API-related impurities (e.g. starting material, by-products, intermediates, chiral impurities, degradation products), including chemical name, structure and o1 Chemical name Structure Origin Process, | degradation Impurity-Az (SE,TE)-9,10-secocholesta. 5,7,10 (19)-trien-3B-ol (trans-cholecalciferol, trans-vitamin Ds) 7 is | Other detectable impurities (B, C,D and E) as per Ph. Eur. monograph, controlled under unspecified impurities with limit not more than 0.10% in final substance specification. The batch analysis data of impurities is given below; Test ‘Specification Batch No. | CHL0417095 CHL0417096 (CHL0417097 Related Substances (By HPLC) Impurity-A NMT 0.1% 0.00% 0.00% 0.00% Unspecified NMT 0.10% 0.04% 0.04% 0.03% impurities Total impurities | NMT 1.0% 0.06% 0.06% 0.04% Residual Solvents ‘Methanol NMT 1000 ppm | 16.55 ppm 22.47 ppm | Ethanol NMT 1000 pp 0.00 ppm 0.00 ppm. Pyridine | NMT 100 ppm 0.00 ppm 0.00 ppm ‘Methyl formate | NMT 1000 ppm 69.51 ppm 55.10 ppm. Petroleum Ether |NMT 290 ppm 3.71ppm | 10.03 ppm _| ‘Acetone NMT 1000 ppm | 6.80 ppm 0.00 ppm [Benzene [NMT2 ppm 0.00 ppm 0.00 ppm Admin. & Regd. Office: A-1501, Thane-One, “il? Complex, Ghodbunder Road, Majiwada, Thane (W)-400 610, Maharashr, India Fax: +91 22.6798 0999 website: www fermentabiotach.com ‘el: #91 22 679808007888, Email fermenta@fermentabiotech.comFermenta Biotech Limited. ‘on: vagesamtteeePLci34021 Tol: #91-22-6798 0888 « Fax: +91-22-6798 0898 Regd. Office :A- 1801, Thane One, DIL Complex, Ghodbunder Road, Majada, Thane (W) - 400 610, Mahsrashia, inca, 2 mal: inflo@ermentabotech com, Website, : wo frmantabotech com Statement about potential impurities Name of the manufacturer: Fermenta Biotech Limited Address: A -1501, Thane One, DIL Complex, Ghodbunder Road, Majiwada, Thane (West) - 400 610, Maharashtra, India. 0 We declare here that known and unknown impuities for the material: " Cholecalciferol are as follows: ‘Sr.No | Impurity Limit T Related substances (Liquid Chromatography) (2.2.29) as per Ph. Eur. Impurity A (trans-Cholecalciferol) Not More Than 0.19% z Unspedified impurities Not More Than 0.10% Total Impurities Not More Than 1.0% iT Residual Solvents fae Methanol Not More Than 1000 ppm : 2 ‘Ethanol | Not More Than 1000 ppm 3 Pyridine Not More Than 100 ppm 4 Methyl Formate Not More Than 1000 ppm 5 Petroleum Ether Not More Than 290 ppm 6 ~~} Acetone rar DPI . _| - 0 We declare here that - No elemental impurities as stated in Appendix-2 of ICH Q3D guideline are intentionally introduced in the manufacture of Cholecalciferol. For Fermenta Biotech Ltd fon Gudhate VP-Corporate QA & RA Date: 12/02/2018 Factory : Vilage Takoll, P.O. Nagwain, Dist. Mandi - 175 121, Himachal Pradesh, india, Tel, : ¥01-1908-287246 /48 /49 Fax: 91-1905 287250 Email info@ermentabiotech.com Website: wiva.fermentabiotech com Factory :Z - 109 8 &C, SEZ I, Dabe}, “Taluka - Vagara, Sujarat, India Jee et-2641-201440/ 444 Ema: info@fermentabiotech.com Website; wwfermentabiotach.com