Certificate of Analysis Somat Weigida ® Amoxy Compacted Type I (Amoxicillin Trihydrate Compacted ) Batch/lot number; +DZ2109110 Manufacturing batch/lot size: 1950.00kg [Manufacturing date: 2021-09-27 Expiry date 2025-08 [Test report number: 3-21-10-C-2-022 Batch release date: 2021-10-05 TESTS SPECIFICATION UNITS. RESULTS, Appearance White or almost white enitaline ‘Almost white ryalline powder powder idenication Conforms to standard infia-red (IR) Complies spectrogram HPLC:The retention time ofthe Complies major peak of the Sample solution corresponds to that of the Standard solution Water by Kart Fischer) 1S 145 Yow Bo Specific optical rotation 4280 0 +315, degree +305 pH 351055 50 Related substances: ‘A Gaminopenicillanic acid) <0s * oor B (C-amoxsilin) <10 % Not detected ‘C (amoxicillin dketopiperazines) S10 % ‘Not deteted D (penicilloic acids of amoxicillin) <10 *% 08s E (penile acids of amoxicitin) <10 * Not detected F G-(thydroxyphenyDpyrazine-2-o) <10 * Not detected G (D-AiydroxyphenyDlyeylamoxciln) <10 % Not detected +H (QR).2-{2.2-dimethylpeopanoy!)amino]-244- aes ag tia <10 % Not detected ‘T((2R)-2-amino-2-(4-hydroxypheny!)acetic acid) s<10 % 0.014 y (Co-oligomers, of amoxicillin and penicilloic acids <10 % ous of amoxicillin) K (oligomers ofpnicilloic acids of amoxiilis) << 1.0 % Not detected (APA amoxicillin amide) <10 % Not deteted ‘Ukovn single impurities <10 % 0st ‘oral impurities <20 % 068 Residual Solvents (GC): Methano! 3000 Pom Not detected Acetone 5000 Pom a Assay (anhydrous) 95.00 102.0 % 999 Suttated ash <0 % 04s sunk dent Untapped afm ost Tapped 0s etn 086 Particle size: Do un 583 Dis un 382 Pharmacopoeia quality: Complies with the current editions of USP41, Ph. Eurd.0, &BP2018. *NDDinetylsitn ited ding the manlcicing proce otis pte or present in ny of ea atrils fthse tests perfomat on atin Soucy. Pes conta! ssh yo ues eat TESTED BY: * {f-v4, CHECKED BY . 483.. APPROVED BY: B Date: get.0G 7A Date: tof .on Dates gt uk) ya) ‘Manufaetured by SINOPHARM WEIQIDA PHARMACEUTICAL CO,, LTD ‘Adatess: Economic & Technological Development Zone, Second Medical Zone, Datong, Shanxi, China 037010 ‘Tel: +86-0352-7698000 Fax: +85-0352-7698001 Web Site: www, weiqida. conCertificate of Analysis Shona! Weiqida ® Amoxy Compacted Type I (Amoxicillin Trihydrate Compacted ) |Batch/lot number: DZ2109110 Manufacturing batch/lot size: 1950.00kg. | Manufacturing date: 2021-09-27 Expiry date: 2025-08 [Test report number: 3-21-10-C-2-244 Batch release date: 2021-10-25 TESTS SPECIFICATION UNITS RESULTS 3 |Solubility Slightly soluble in water, very slightly ‘Complies. ' soluble in ethanol (96 per cent), practically insoluble in fatty ols. It dissolves in dilute acids and difute solutions of alkali hydroxides. Identification ‘TLC: The principal spot in the Complies chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). 7 Chemical test: A dark yellow colour ‘Complies develops. 7 ‘Not more opalescent than reference Complies | Appearance of solution(in HCI /NH,OH) suspension IT 5 - Not detected [Residual solvents NN-Dimethylaniline: 20pm (Not used in process) Ceystatinty Meets the requirements Complies Microbial limit: ‘Total aerobic microbial count <10 cfg ‘Complies ‘Total Yeast/molds count <10° cfu/g ‘Complies E.coli Not detected Complies 2 TESTED BY: % Teoh CHECKED BY : «ny APPROVED BY : 5007" Date: 964.25, WX Date : o¢t.25. 202 Date: pf, wr 2) Manufactured by SINOPHARM WEIQIDA PHARMACEUTICAL CO.,LTD. Address: Economic & Technological Development Zone, Second Medical Zone, Datong, Shanxi, China 037010 ‘Tel: +86-0352-7698000 Fax: +86-0352-7698001 Web Site: wr. weigida. com