UNICHE ivi @ LABORATORIES LTD. Plot No. 197, Sector, Pithempur ~ 454 775, Dist. - Ober (HLF) NTA, Tet. No, : 07252-16600, 418607 Fax Ho, :07282-618606, Wabste: wunwanichemabs. cam CERTIFICATE OF ANALYSIS (FINISHED PRODUCT (For API) Product Batch No. PPHLP40001 Product Code 10000829 Specification td GNVAPISIPHLO1/03 Mfg, Date Jub 2014 Retest Date Jun-2017 PHENYLEPHRINE HYDROCHLORIDE USP LMS AR. No, PPFP1s00244 SAP Inspection LotNo > 040000083041 STP No, GINAPISTPIPHLOT/O2 Date of Release ul 23 2014 Batch Quantty 150.40 KG ‘S.No. TEST I ‘SPECIFICATION RESULT 4 1 | Description | White or practically white, Practically white, odorless | | odorless crystals having @ biter | crystals having a bitter taste | | taste. _ _— | 2. | Solubility | Freely soluble in water and in | Freely soluble in water andin Ot | ethyl alcohol, ethyl alcohol. ae (3. [identification [37 Tayir The IR spectrum ofthe sample | The IR spectrum of the sample is should be concordant with the | concordant with the spectrum | spectrum abtained from ‘obtained from working standard. _ _rGterence / working standard 3.2. | Test for chioride ‘A white precipitate is formed | Awhile precipitate is formed | Which is insoluble in nitric acid | which is insoluble in nitric acid | bout soluble after being well | but soluble efter being well | washed with waterindiute | washed with waterin dilute | is reprecipit ‘ammonia solution from which it | ammonia solution from which itis fated by the addition | reprecipitated by the addition of of dilute nitric acid, dilute nitric acta [Mating range Between 140°C and 145°O | 142°C to 144°C 5.__| Specific rotation Between ~42° and ~47.5" | 43.5" 6. | boss on drying (wh) 0.22% @ |__| Residue on ignition (buh - 0.08% 8. | Suiphate content NMT 0.2% Loss than 2% 9. Limit of ketones ‘The colour of the final solution | The colour of the final solution is | should not be deeper than that | not deeper than that obtained in [_ Stained ina conta solution. _| a cont solution | 10, | Chromatographic purity by TLC (Y%wAv) | TO. [ individual impurity NUT O55 Not detected | 102 | Total impurities NMT 1.0% Not detected { [ Remarks: APPROVED (Sample Conforms to above Specification) Checked By ] [Approved By ye" _ [eens uy | siay core ge \0IM | exeeuve- a0) | {Oy Manager-a8) | Ghecked On | seo7.a0%4 [Approved On | Soav zoe | Form No, LSTRCOR TOD ‘GE OFE Ucar avon, SV Read Seah Page No: 1 of2 ‘Wal - 400702 NOW = Te BF ERGBREIS + Fa BT DOBTEROT = Ws wr ESAS Sr CIN NUMBER : - Lesg99MHi86zPLCo12451GB NG Ge aE VE ity ee i LABORATORIES LTD. Fett. 0282-e6, Met nncunicents om CERTIFICATE OF ANALYSIS (FINISHED PRODUCT (For API) Product PHENYLEPHRINE HYDROCHLORIDE USP Batch No. PPHLPA0O01 LMS AR. Ne. pPrP14o026 Product Code 10000629 SAP Inspection Lot No > 049009089041 Specification Id GAVAPISIPHLOYOO3 STP No. GAIAPISTPIPHLO1I02 Mfg. Dato Jul2014 Date of Release Jul 23 2014 Re-testOate un-2017 Batch Quantity 150.40 KG [Exe TESTS —TSRECIFICATIONS RESULTS 11. | Chipride content by tration | Between 17.0% and 17.7% 17.4% (Col) (on dried basis) | [72 Tasch by tation wie) | Between 978% and 102.5% | 8B. | | (on dried basis) i | -_ € [ADDITIONAL TESTS 1.__| Rethted substances by HPLC (9 wiw) — 13.4_| impurity C [NUT OT [Not Detected _| 732 | Impurity E NMT 0.1% NerDatected | 13.3 | Unspecified impurities __[NMTO.10% Not Detected | 18.4 | Totdl impurties NW - NotDateded i 14._| Residual solvents by GC _ _ 14.1 | Ethylacetate NMT 5000 ppm_ _ [Not Detected _ 14.2 | Tollene NMT 890 ppm, Not Detected 14.3 | Isopropyl alcohol NIT 5000 ppm | [44.4 [Methanot NAT 3000 ppm i} un, HELM GE MenIcos G GONTROL DE CALIDAD : al | 19.00 a APROBADO) amar APPROVED apie CanTSTANTS thove Speciation) 7 ‘Checked By | Approved By Wer”, voresh yn Guy | ‘ny cow WR (Exovutive - QC) a9}-F]14 | (oy. anegera4) | + ——o Checked On 30.07.2044 [Approved On| 0.072016 [Form No, LINSIACOA-010I01 Page No: 20f2 COA reissued on 30.07.2014 for Mis HELM DE MEXICO, MEXICO, ORE OF Unie Svan, Red ea (Mba OTOP. WR > TW ORERRERIG «Ti TERGAT > WO CROSS CIN NUMBER : - LesssoMtt962PL.C012451