ANUH acho cttn00727 PHARMA LTD. ADDRESS: 3A, Sniaopar Esto Nath Wing, OF, Ana Began Road, Wo, kerb 40001, TEL: 4012265227576! 876 | FAK: #91 72.6022 7800/600 —JEMAIL: anuhggees622.emn IRREVOCABLE DOCUMENTARY CREDIT NUMBER LC/O1/012/7761 DATE OF ISSUE 171116 AS PER INDENT NO, 62801/2017 DATED 05/10/2047, IMPORTERS N.T.NNO. 0706428.7 H.S, CODE NO. 2041.6000, COUNTRY OF ORIGIN : INDIA [GERTIFICATE OF ANALYSIS i Fommarnar earn | PRODUCT DETAILS cee — sarcH DEALS ———————- tem Nine: Envomyei Sterao EP (Phamacota! Row || Baths esr 125117 Nteol of Pharmootucal rods) ue ty so0.c00 tg ripen | E2017 12001 Manitctuing no} NOV. 2017 bao 05/12/2017 fly Ono ocr. 2000 RESULTS: [SPECIFICATIONS AS PER EP 9.0 Waite or almost crystalline powder. Wie aan ponder | Soiabingy ‘Complies Practically Insoluble in water, soluble in ecetone and in| Hee a oe __ [methanol Solutions may be opalescent, | Taendiction “Complies Infrared aborpion spedtrophotemeiry. Gomparison lenthromycin stesrats WRS. try) 9.95% Maximum 14.0 per cent (abhydrous substance) of _|orsHsco2 FFroo Stoaris Acid (By elated substances y HPLC) impurity © Maximum 30% | impurity A = [Manimiam 2.0% as 7 impuryB [Maximum 2.0% ees ‘| in [Maximum 7.0% PeeEeeeeeet [Manimum 1.0% an [Micrnum 1.0% iz sts |Meximum 1.0% E Ht i inparty Below detection iit taxi 0.4% cH ‘Any other impurity [tr iam 0.4% ‘Total Impurities 320% ‘Maximum 7.0% ‘Water (By KF) 1.76% Maxdmum 4.0% | Stifatod ach Peer 0.06% Mavimum 0.8% “| REMARKS. - “The camplo compiice withthe prescribed standards of quaity as per EP 8.0 ROCHE roost Sut repos rena Rat Doskmton :¢-chenit Dosignion acinar oslintze! osu2olF Factory: E1718 & 1714, MLO. Tara BOISAR,DIst Paighar- 401 S06 INDIA Te 19 2528605 961/605 362 nmeANUH Daas. cI 707210 PHARMA LTD, ADDRESS: 9A, SniangorEstoNNoth Wop, Os, Ane Besar Read, Wer, Mumbet 400018 TEL; 181 226622 7675157 | FAK: +81.226622.7500/600 (EMAL pekt932.00m IRREVOCABLE DOCUMENTARY CREDIT NUMBER LCIO V01217761 DATE OF ISSUE 171115 AS PER INDENT NO, 5280112017 DATED 05/10/2047, IMPORTER'S N.T.N.NO. 0708428.7 H.S, CODE NO. 2041.5000, COUNTRY OF ORIGIN : INDIA (GeRTIRCRTE OF ANALYSIS FORT NO? BOTS. fe -PRODUCT DETAILS arc Dea —— —— ftom Name: Erythromycin Steerate EP (Pharmaceutical Row || Batch No, EST 125K 17 * Milool of Pharmacoutea rads) malate mone repos | 20K? 2001 Mondatvingbne + NOV. 2047 a 06/12/2017 Bey Oat ‘ocr, 2020 ‘Assay(By HPLC) ‘Sum of enthrontycine AB and © | expressed awstewaloe Erythromycin 8 etoarata Enythremyain C soarato REMARKS. ‘The sample compliés with tha prescribed standards of quality 8s per EP 9.0 STGH RELEASE BY OE r | | | eer Analyst suit Approms —: Suoneva Ral Designation ‘chant Designation ac ate Te ae a os iiaites 3 ctor: E4718 & 17, WLLD.C.TerapurBOISAR.DIt Palghar— 401 S06 INDIA Tel + 2525605 361 605352