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RUMGCO
CERTIFICATE OF ANALYSIS
Product Name Naltrexone Hydrochloride
Pharmacopeial Compliance USP Date of Sampling 10.t1.2021
Batch No NTXAUM2IOOI Date of Release 13.11.2021
Date of Mfg. November-2021 Batch Size 5.510 Kg
Date of Retest October-2025 Dispatch Qty NA

Sr.
Test Specification Result
No.
Description A white or almost white powder very An almost white powder very
I
hygroscopic. hygroscopic.
Freely soluble in water, slightly soluble
2. Solubility in ethanol (960/o) practically insoluble in Meets the test
methylene chloride
J. Clarity of Solution 4t NM'f 3 N]-Us Less than 3 NTUs

Identification
A) By IR A) Concordant with the reference A) Concordant with the reference
spectrum. spectrum.
4. B) Assay by HPLC B) The retention time of the Naltrexone B) The retention time of the Naltrexone
peak of the sample solution corresponds peak of the sample solution corresponds
to that ofthe standard solution, as to that of the standard solution, as
obtained in the assay obtained in the assay
5.
Specific Optical Rotation calculated 187 'to - 1970 190.9t "
on anhydrous, solvent free basis
6. Water Included in lirnit of total solvents. 6.50%
7. Residue on lgnition Not more than 0.1% 0.050/,
8. Limit of total solvents sum of water
and total solvents Not more than I 1.0 % 6.50 %
(Methanol and Ethanol)
Organic Impurities
I ) Noroxymorphone Not more than 0.50% Not Detected
2) I O-hydroxynaltrexone Not more than 0.50 % Not Detected
3) Naltrexone related compound A Not more than 0.50 % Less than 0.05%
9. 4) 2,2-Bisnaltrexone Not more than 0.50 % Not Detected
5) l0-Ketonaltrexone Not more than 0.50 % Not Detected
6) Any Unspecified Impurity Not more than 0.50 % Not Detected
7) Total Impurities Not more than 1.5 oh 0.19%

Content of chloride on the

r0. 9.20 to 9.58 % 9.27 %
anhydrous, solvent free basis
Assay C20H23NO4 HCL on the
il 98.0%to l02.0oh 99.81%
anhydrous, solvent free basis

Remark: The Product rneets the above specification of Naltrexone Hydrochloride USP, hence is of the standard quality.

Prepared by Anoroved bv

Signature& Date
24 )tt/2Q t
Name 291rl)oYt
Shivark.x o'F. Hi<er1
r
p.1"{

AUMGEN PHARMA LLP. Works : Plot No. 7415, Karmatur Chowkdi, G.|.D.C., Ankleshwar - 393 002. Dist. Bharuch, Gujarat. (lNDlA)