Manufacturing, Address: No. 6121 Longquan Road, Zhanggi District, Jinan City, Shandong, Province 250200, China. E-mail: sales@jindapharmcom TEL: +86-531-89900814 FAX: +86-531-88902114 Certificate of Analysis Product Name: Nitrofurantoin BP2012 FRRAACARAA Jinan Jinda Pharmaceutical Chemistry Co,Ltd. COA No: P-2-202101002 BATCH NUMBER jp-P-2.20191207 ‘TEST DATE December 16, 2019 BATCH SIZE 1000Kg MANUFACTURE DATE December 08,2019 QUANTITY / RETEST DATE December 02, 2022 ANALYSIS SPECIFICATION RESULT Appearance (Visual) A yellow crystalline powder or yellow crystals. Conforms Identification A (BP) ‘The solution should show two absorbance maxima at 266 and 367m. The ratio of the maximum absorbance at 367nm to that of the maximum absorbance at 266nm should be 1.360142 Conforms Identification B(BP)__A brown colour develops on reaction with specified reagents. Conforms Loss on drying (BP) Not more than 1.0%. w/w 060% Sulphated ash (BP) Not more than 0.1% w/w on 1g of sample. oom Related Substances (TLC) on [Not more than 0% <10% “Assay (UV) (BP) 98.0 to 102.0% (Calculated on the dried basis) 100.7% Residual solvent (GC) (In-house) Methanol [Not more than 500ppm 6pm Acetone [Not more than 500ppm <18ppm Particle Size (Malvern Particle Size Analyze) (In-house) Dao) [Not moré than 10.» m sum ‘D(S0) : um Deo) s8um Concho: Tis batt ps are: SED /r02). od Signed/ Date: Sh Ax [2-07]. of. 12 ie bach hes been manufactred, including Prepared by QA: Reviewed by QA: ‘Sun Yingwen We hereby certify that the above information is authentic and accurate. packaging and quality control, at the above-mentioned site(@) in full compliance with Guidelines in ICH Q7. The batch processing, packaging and analysis records were reviewed and found to be in compliance with GMP. (Qualified Person: Wang Shuai Signed/ Dat: de>. elie Page 1 oft FNTY-04-00/July 24, 2019