Page No 1 of 2 CTX Dreaciences __ CERTIFICATE OF ANALYSIS z = none PRODUCT: LINAGLIPTIN IL _ Batch No. 21LP000001 Inspection Lot No. _: 40000023189 Mfg. Date May 2021 Batch Quantity 0.100 ke Retest Date : April 2022 DateofRelease + 25/05/2021 S.No. Tests Observations Specifications Method — Reference 1. | Description Slightly yellowish White to yellowish In-house crystalline powder. crystalline powder. | 2._| Solubility Soluble in methanol and | Soluble in methanol and In-house very slightly soluble in very slightly soluble in isopropyl alcohol isopropyl alcohol 3. | Identification by IR | Infrared spectrum of the | Infrared spectrum of the In-house test is Concordant with _ | test should Concordant the infrared spectrum of | with the infrared spectrum. the standard obtained in | of the standard obtained in the same manner. _| the same manner. 4. | Identification by Retention time of major | Retention time of major In-house HPLC peak observed in the peak observed in the sample chromatogram is | sample chromatogram correspond to that of should correspond to that major peak of Linagliptin | of major peak of in system suitability Linagliptin in system solution as obtained in | suitability solution as obtained in the S-(-)- Linagliptin content test. | isomer of Linagliptin content test 3. | Loss on drying 0.19 ‘Not more than 1.0 In-house (Cowiw, at 105°C for 3 hours) 6 | Residue on ignition [0.03 Not more than 0.1 In-house (owiw) 7._|S-C-isomer of 0.06 Not more than 0.15 In-house Linagliptin content (“owiw, by HPLC) S- (isomer of Linagliptin _ - 8 [Related substances | 0.02 Not more than 0.15 In-house (% wiw, by HPLC) Any individual maximum, unspecified impurity Prepared by Checked by Approved by rept Le ret 1 CEE ae Chhatrasinh Girase a Patel Chetan Modi Assistant - QA Asst. Manager - QA Dy. Manager - QA 251-252, Sachin Magdalla Road ist: - Surat (Gujarat) India, Tek: +91-261-2399669, fax: +91-261-2398547,PRODUCT: LINAGLIPTIN IH Page No 2 of 2 CERTIFICATE OF ANALYSIS. Batch No. 211.P000001 Inspection Lot No. : 40000023189 Mfg. Date May 2021 Batch Quantity 0.100 kg, Retest Date ‘April 2022 Date of Release 25/05/2021 S.No. Tests Observations Specifications Method Reference 9. | Related substances | 0.08 Not more than 1.0 In-house (% wiw, by HPLC) Total impurities 10. [Assay (%wiw,as | 99.3 Not less than 98.0 and not | In-house CasHagNyOz on dried more than 102.0 basis by HPLC) TI. | Residual solvents | Not detected ‘Not more than 880 In-house (ug/g, by GC-HS) N,N-Dimethyl formamide - 12, | Residual solvents | Not detected Not more than 5000 In-house (ug/g, by GC-HS) Dimethyl sulfoxide 13, | Residual solvents | Below detection limit | Not more than 3000 In-house (ng/g, by GC-HS) Methanol - - 14, [Residual solvents | Not detected Not more than 600 In-house (ug/g, by GC-HS) Dichloromethane 15. [Residual solvents | Below limit of Not more than 5000 Ti-house (ug/g, by GC-HS) quantification Ethyl acetate - 16. | Residual solvents | 4219 Not more than 5000 In-house (ug/g, by GC-HS) ____| Isopropyl alcohol Remark: The Product Complies to above Specifications. Prepared by Checked by Approved by FE soso p9PeteZ1102 | Coe Chhatrasinh Girase Hemant Patel Chetan Modi Assistant - QA ‘Asst. Manager - QA Dy. Manager - QA Works at: CTX Lifesciences (P) Ltd, Block No: 251-252, Sachin Magdalla Road GIDC - Sachin, Dist: - Surat (Gujarat) India, Tel: /91-261-2399669, fax: +91-261-2398547.