product Name Naltrexone Hydrochloride “Pharmacopocial Compliance: iG ‘Batch No NTXAUM20002 [Date or te December=2020 Date of Retest November-2024 ae ‘Test Specification Result jo. 1 Peson Avaie ralvost white powder very “naman white powder very RyBFOSCOpIe hygroscopic Freely soluble in water, slightly soluble in 2 ‘Solubility ‘ethanol (96%) practically insoluble in Meets the test mnethylene chloride Taenaifeation A)ByIR A) Concordat withthe reference specrum. | A) Concordant with the reference 3 spectrum B) It gives reaction(a) of B) To meet the test chlorides B) Mees the test Sorlon S clear E wat wore Ttenaely | Meets the test “Appreance of solution coloured than reference solution YSS or 4 BSS ‘edty or Alkalinity NMT020m1 00.02 MNaOHor6.02M | 0.10mi002M HCL is required. s HCl is required to change the colour of the indicator. ©._| Specific Optical Rotation =187*to 195" =i" Related substances by HPLC impurity A Not more than 0.10% ‘Not Detected 2) Impurity B Not more than 0.10% Not Detected, 3) Impurity C Not more than 0.20% Not Detected 4) Impurity D Not more than 0.21 Not Detected. 5) Impurity E Not more than 0.2 Not Detected. 7. | 6)Ampority F Not more than 0.2 Not Detected 7) Impurity G Not more than 0.2 Not Detected 8) Impurity H Not more than 0.10% Not Detected 9) Impurity 1 Not more than 0.10% Not Detected 10) Impurity J Not more than 0.10% 0.08% 11) Any other Not more than 0.10 ‘Not Detected 12 Totallmpurities, Not more than 1.0 0.08% &_| Ethanol ‘Not more than 3.0% ‘Not Detected 9,__| Water Not more than 10.0 % 393% 10,_| Sulphated ash Not more than 0.1% 0.06% TI. Assay(anhydrous substance) _ | 98.0% to 102.0% 99.46% Remark: The Product meets the above specification of Naltrexone Hydrochloride IP, hence is of the standard quality. L Prepared by T ‘Approved by al Signature& Date fame ! bivarchar D+ Aer Page 1 of 1 AUMGEN PHARMA LLP. Works : Plot No. 7415, Karmatur Chowk, 6..0.C, Anieshwar - 989 002. Dist Bharuch, Gujrat. (INDIA) Regd. Off: 201, Camps Corner Nr, Susen Circle, Opp. SRPF Ground No. IX, Makarpura Main Road, Vadodara - 390 009. Mobile : 70437 83916, 63587 66558, Tel No. : 0265-2645815 Email : aumgenpharma@gmail.com