© -34,M..D.C., Tarapur, Boisar — 401 506, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUGT _| DOXOFYLLINE IH SPECIFICATION NO- P/FMS/QOC/001-00 EFFECTIVE DATE NOV 200 | OBSOLETE NO. wa NEXT REVIEW DATE OCT 2027 PARTY NAME RENATA LIMITED | PAGE NUMBER 10F 16 po AAREY DRUGS & PHARMACEUTICALS LTD. Molecular Formula | CriH ise, Molecular Weight 266.3 gimol CAS No. 69975-86-6 a tye : ‘Sampling plan ‘As the material is active pharmaceutical ingredient, 100% sampling to be done, withdraw the sample from each bag for complete analysis. Sample to be drawn from | Draw ihe sample fram top, middie and sampling SS scoop / sampling rod ‘Sample to be drawn with | Use SS sampling rod / SS scoop having long handle. “Quantity of sample to be | Quantity of sample for analysis: 150.0 gm taken Quantity of contro! sample: 80.0 gm Store protected from light and moisture, at a temperature not exceeding | 30°C. Standard Pack Size 1x 25.0 kg in HOPE Drum | Fibre Drum Expiry Period S years Pharmacopeial Reference | IH Harmful swallowed, Material may be irritating to the mucous membranes Hazardous and upper respiratory tract. May be harmful by inhalation or skin absorption. May cause eye, skin, or respiratory system irritation. ‘Storage Condition | 2. Remove to fresh air. if not breathing, give artificial respiration or give oxygen by trained personnel. Get immediate medical attention. Propared By (QC) Reviewed By (QC) Approved By (QA) nat “Com Injeery |S| Cpt AAREY DRUGS & PHARMACEUTICALS LTD. | E-34, M1.0.C., Tarapur, Boisar ~ 401 506, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION [NAME OF PRODUCT | DOXOFYLLINE IH SPECIFICATION NO. —_ P/FMS/QG/001-00 EFFECTIVE DATE. O5 NOV 2024 | OBSOLETE NO. NA [NExTReviewpaTe | 94 OCT 2027 | PARTY NAME | RENATA LIMITED. PAGE NUMBER 2 OF 16 | “3 Immediately wash skin with soap and plenty of water for af least 15 minutes. Remove contaminated clothing. Get medical attention if ‘symptoms oceur. Wash clothing before reuse, 4, Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes, Have ayes examined and tested by medical personnel. 5, Wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Get medical attention. Do NOT induce vomiting unless directed to da se by medical personnel, Prepared By (QC) | ae Approved By (QA) _ MW 900% L Posi lasee a Hoes FORMAT NO. QA002-01/F1i jay AAREY DRUGS & PHARMACEUTICALS LTD. E-34, M).0.C., Tarapur, Boisar - 401 606, District Paighar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUCT | DOXOFYLLINE IH SPECIFICATION NO. _ | PIFMSIQG/001-00 EFFECTIVE DATE 0 _ OBSOLETE NO. NA NEXT REVIEW DATE | 9) PARTY NAME [RENATA LIMITED PAGE NUMBER [BOF 16 [[Link], | TESTS ‘SPECIFICATIONS REFERENCE 1. | Description A white to off white crystalline powder, 1H _ ~ ‘Soluble in water, in acetone, in ethyl acetate, in 2 Solubility benzene, in chloroform, in dioxane and in hot IH , methanol o¢ in hot ether: practically insoluble in ethy! ether. identification la. ByIR | infra-red spectrum of the sample corresponds to eu 3 | that of the working standard. The retention time of the major peak of the B. By HPLC sample ‘solution corresponds to that of the IH standard solution, as obtained in the assay. 4. |Loss on Drying Not more thar 0.5% | S| Suiphated Ash Not more than 0.1% iH Related Substances (By HPLC) eg. __e Theophytine Not more than 0.5% Any Other Impurity | Not more than 0.5% IH [% Total Impurities Not more than 1.0% = 7, Assay By HPLC Not less than 96.5% and not more than 101.0% iH (On dried basis) of CHudNaOxon dried basis, 8 ‘Melting Point between 142.0°C and 146.0°C iH 9 Bulk Density between 0.45gimi to 0.85g/m! 1H Sieve Test _ 40, | 80 mesh 5 0% retained maximum i wOmesh 0% retained maximum iH Microbial Limit Test Total Aerobic Microbial nol more than 1000 efu/g 14 Count: - 2 11, | Tota) Combines Nolés not more than 100 cfu'g iW Pathogens [Escherichia Colt ‘absentia L «a Prepared By (QC) Reviewed By (QC) Approved By(QA) | Dy chy estiitaone | “aspireaty Awe FORMAT NO. QA002-01/F1pe AAREY DRUGS & PHARMACEUTICALS LTD. E-34,M.0.C., Tarapur, Boisar — 401 506, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUCT | DOXOFYLLINE IH SPECIFICATION NO. | PIFMS/QG/001-00 _| EFFECTIVE DATE O5 NOV 2024 OBSOLETE NO. NA NEXTREVIEWOATE | 4 OCT 2027 PARTY NAME RENATA LIMITED PAGE NUMBER | 4 OF 16 DESCRIPTION Instrument: Analytical Balance Procedure: Transfer about 1 to 2 gm of sample in a glass petri dish and spread on surface of the dish. Observe the sample in a day light for appearance, nature, visual contamination and presence of any extraneous matter such as brown/black particles. Acceptance criteria: A white to off white crystalline powder. SOLUBILITY Instrument: Analytical Balance Procedure: | Solubility Profile | Sample quantity required ‘Soluble 1.09 sample in 10 ta 30 mi | Seluble ‘gm sample in 10 to 30 mi ‘Soluble | 09m sampie in 70 t0 30 mi Ethyl Acetate Soluble | Tig aris 10 6 307 Benzene Soluble 7.0gm sample in 10 te 30 mi Chloroform ‘Soluble 4.0gm sample in 10 to 30 mi Dioxane Soluble 709m sample in 10 te 30 mi Hot Methanol ‘Soluble 7.0gm sample In 10 to 30 mi Het Ether Practically Insoluble | 0.01 gm samp in 100 mm or over | Ethyl Ether Acceptance Criteria: Soluble in water, in acetone, in ethyl acetate, in benzene, in chicroform, in dioxane and in hot methanol or in hot ether; practically insoluble in ethy! ether. Prepared By (QC) Reviewed By (QC) ——e | - sD st ostulnane wd 4 wr FORMAT NO.. sees:pee AAREY DRUGS & PHARMACEUTICALS LTD. E=34,M1.D.C,, Tarapur, Boisar— 401 506, District Paighar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUGT _ | DOXOFYLLINE IH | SPECIFICATION NO. | PIFMS/QC/001-00 EFFECTIVE DATE 05 NOV OBSOLETE NO. NA NEXT REVIEW DATE - PARTY NAME RENATALIMITED | PAGE NUMBER [SOF 16 3 IDENTIFICATION AL ByIR: Instruments: Analytical balance Fourier Transform infrared Spectrometer Standard: Doxofylline Working Standard / Reference Standard. ‘Standard Preparation: Grind the Doxofylline werking standard in mortar to fine powder with pestle and spread the Mefenamic Acid working standard fine powder uniformly on ATR and sean. Sample Preparation: Grind the test sample in martar to fine powder with pestle and spread the test sample fine powder uniformly on ATR and sean. Note: If working standard spectrum is already saved in system library, compare sample spectra with working standard spectra in library. Compare the spectrum obtsined with that of Daxofylline CRS or working standard or with spectrum of Doxofyline Acceptance Criteria: Infra-red spectrum of the sample corresponds to that of the working standard Prepared By(QC) Reviewed By (QC) ‘Approved By (QA) 3 ) Fon __“Ssfrieeny Y PRC FORMAT NO. QA002-01/F 1ory ffy | AAREY DRUGS & PHARMACEUTICALS LTD. E~ 34, M.0.C., Tarapur, Bolsa’ — 401 506, District Paighar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUCT | DOXOFYLLINE IH SPECIFICATION NO. _ | P/FMS/QC/001-00 EFFECTIVE DATE 05 Nov 2028 ‘OBSOLETE NO. [NA NEXT REVIEW DATE 4 OCT 2027 [PARTY NAME (RENATALIMITED | PAGE NUMBER 6 OF 76 8. By HPLC: Instruments: Analytical Balance HPLC Procedure: Refer procedure as per test Assay. ‘Acceptance Criteria: The retention time of the major peak of the sampie solution corresponds to that of the standard solution, as obtained in the assay, LOSS ON DRYING Instruments: Analytical Balance Hot Air Oven Procedure: Dry the clean LOD bottle in oven for 30 min, at 105°C + 2°C, cool in desiccators for 30 min. Weigh the empty LOD bottle and note the weight as Ws. Accurately weigh and transfer about 1.0. gm sample in LOD bottle and record the weight as Wz. Close the LOD bottle with lid and gently shake the bottle to distribute sample uniformly. Open the bottle and keep the LOD bottle with semi-open lid in oven. Dry the sample at 105°C + 2°C for 4 hrs. after drying, take out the LOD bottle with lid and cool in desiccators for 30 min. Weigh the LOD bottle Again, dry the sample at 105°C + 2°C for 30 min. and record the weigh as Ws. Repeat the procedure until two successive weighing does not differ by more than @.0005 gm. Prepared By(QC) —_—| Reviewed By (QC) ‘Approved By (QA) owo< ? ~ astiiinang Sa) ay sso FORMAT NOT GAG02-O1FIE-34, MI.D.C., Tarapur, Boisar~ 401 506, District Palghar, Maherashtra pe AAREY DRUGS & PHARMACEUTICALS LTD. NAME OF PRODUCT FINISH MATERIAL SPECIFICATION DOXOFYLLINE IH SPECIFICATION NO. _| P/FMS/QGi001-00 EFFECTIVE DATE OS HOV 207 OBSOLETE NO. NA | NEXT REVIEW DATE 04 OCT 2027 [PARTY NAME RENATA LIMITED | PAGE NUMBER 7 OF 16 Calculation: (Wa Wa) % LOD = —————1 (Ws Ws) Where W, = Weight of the empty LOD bettie. W, = Weight of LOD bottle + sample. Ws = Weight of LOD bottie + sample after drying. Acceptance Criteria: Not more than 0.5% SULPHATED ASH Instruments / Apparatus: Analytical balance Muffie furnace Silica Crucible Desiccator Reagents: Sulphuric acid (ARILR grade) Procedure: Dry the clean crucible in muffie fumace at 600° + 25°C for 30 min., cant in a desiccator for 30 min. Weigh the crucible and note the weight as W1_ Accurately weigh and transfer about 1.0 g of sample into crucible and note the weight as Wz Moisten the sample with 1 ml of sulphuric acid and heat gently at as low a temperature as practicable until the sample is thoroughly charred. After cooling moisten the residue with a small amount of sulphuric actd, heat gently until white fumes are no langer evolved. Ignite at 600" + 25°C until the residue is completely incinerated. Allow the crucible to coal in a desiccator over silica ge! and weigh it, Further heat the crucible at 600" + 25°C for 30 min. Cool and Prepared By (QC Reviewed By (QC) __ Approved By (QA) ata afl 202 rere’ FORMAT NO. GAQO2-O1/F1 ostiilaoagAAREY DRUGS & PHARMACEUTICALS LTD. E-34, MILD.C,, Tarapur, Boisar— 401 506, District Palghar, Maharashtra | Open FINISH MATERIAL SPECIFICATION | NAME OF PRODUCT DOXOFYLLINE IH - [SPECIFIGATIONNO. | PiFMS/acio01-o0 | EFFeCcTIVeDATE | O68 NOV 2020 OBSOLETE NO. NA [NExTREvIEWoaTE | Q4 OCT 2027 PARTY NAME RENATA LIMITED | PAGE NUMBER [BOF 18 weigh it. Note the weight as Ws. Repeat the procedure until two successive weighing do not differ by more than 0.0005 g, Calculation: (Wa Wi) % Sulphated Ash =x 100 (Wa= Ws) Where, W:= Weight of empty crucible in g. W:= Weight in g of the crucible with sample before ignition Ws = Weight in g of the crucible with ash after ignition, Acceptance Criteria: Not more than 0.1 %. 6, RELATED SUBSTANCES BY HPLC Instruments | Apparatus: HPLC with UV detector Analytical balance Volumetric flask Pipette Beaker Ultra Sonic Cleaner Standards: Doxotyliine working standard Theophylline working standard Chemicals / Solvents / Solutions: Acetonitrile (HPLC Grade) Water (HPLC or equivalent grade) Prepared By (QC) Reviewed By (Qt Approved By (QA) Nn 2 a0 Ee luslnon ow xe | FORMAT NO. QA002-01/F1Ope AAREY DRUGS & PHARMACEUTICALS LTD. E34, M.0.C,, Tarapur, Boisar — 401 508, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PROQUGT _ | DOXOFYLLINE IH SPECIFICATION NO. _| P/FMS/QGI001-00 EFFECTIVE DATE 05 NOV 207 ‘OBSOLETE NO. NA NEXT REVIEW DATE d | PARTY NAME RENATA LIMITED | PAGE NUMBER 8 OF 16 Mobile phase preparation: Mix 800 volumes of water and 200 volumes of acetonitrile Test solution: Accurately transfer about 100 mg af sample under examination into a 100 mi volumetric flask, add 75 ‘mi mabile phase, sonicate to dissolve and dilute upto the mark with mobile phase. Reference solution (a): Accurately transfer about 50 mg of Doxofyline working standard and SO mg of Theophylline working standard into a 100 mi volumetric flask. Add about 30 mi of mobile phase and sonicate to dissolve, ‘Make up the volume upto the mark with mobile phase. Reference solution (b): ‘Transter accurately 1 mi of reference solution (a) into a 100 ml volumetric flask and dilute upto the mark with mobile phase. Chromatographic Conditions: ‘The liquid chromatography equipped with an UV detector, an injector and a data processor. meter Standard Condition — ‘coum ~*~ TB ASM AAGMM) Sumpariceszecrequvale’ == | [Flow Rate 0.8 mumin | Detection Wavelength | 274 nm Column Temperature | Ambient injection Volume 20 ul Run Tine 30 minutes Procedure: Inject 20 yl each of diluent as blank in singlet, reference solution (b} in five replicates and again diluent as blank in duplicate and then, test solution in singlet into chromatograph. Run and record the chromatograms. |___ Prepared By (QC) Reviewed By (QC) I ‘Approved By (QA) tO“ ay | otitlnose | "tee a AWN! FORMAT NO.: QA002-01/F1(pee AAREY DRUGS & PHARMACEUTICALS LTD. —34,M.1.0.C., Tarapur, Boisar -— 401 506, District Paighar, Maharashtra NAME OF PRODUCT | DOXOFYLLINE IH FINISH MATERIAL SPEGIFIGATION | PARTY NAME SPECIFICATION NO._| P/FMS/QC/001-00 EFFECTIVE DATE | 06 NOV 20% OBSOLETE NA NEXT REVIEW DATE | 04 OCT 2027 ENATA LIMITED | PAGE NUMBER 10 OF 16 For system suitability in reference solution (b): The test is not valid uniess the resolution between the peaks due to Theophylline and daxofylline is nat less than 5.0 and relative standard daviatian for replicate injections is not more than 5.0%. Acceptance Criteria: The area of the peak due to Theophylline in test solution is not more than the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.8%) and the area of other secondary peak is not more than the area of the peak in the chromatogram abtained reference solution (b) (0.5%). The sum of the areas of all the secondary peaks is not more than twice the area of the peak in the chromatogram obtained with reference solution (b) (1.0%). Calculation: Calculate the percentage of Theophylline by using the following formula. %Theophylline=Result = (rita) x ox x 100 Where, Peak area of Theophylline in test solution, Average peak area of Theophylline in reference solution (b). concentration of test solution and ref solution (b) in Theophylline. ca Calculate the percentage of any other impurity by using the following formula. ‘%Any Other Impurity=Result = {rults) xc. x 100 Where, r= Peak area of Any other impurities in test solution, f= Average peak area of doxofylline in reference solution (b). = concentration of lest solution and ref solution (b) in daxofylline Total of all impurities: Total known impurity + Total unknown impurities Prepared By (QC) | Reviewed By (QC) [ ‘Approved By (QA) a W-Caolh ake FORMAT NO- QA002-01/F1 Sestilaaag Esp 20%ptr AAREY DRUGS & PHARMACEUTICALS LTD. E~ 34, M..0.C,, Tarapur, Boisar ~ 401 508, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUCT DOXOFYLLINE IH ‘SPECIFICATION NO. P/FMS/QGi001-00 EFFECTIVE DATE OBSOLETE NO. NA NEXT REVIEW DATE PARTY NAME RENATA LIMITED PAGE NUMBER impurities [9% Total Impurities ‘Acceptance Criteria % Theophylline % Any Other Impurity Not more than 0.5 % Not more than 0.5% Noi more than 1.0% ASSAY BY HPLC (ON DRIED BASIS) Instruments / Apparatus: HPLE with UV detector Analytical balance Volumetric flask Pipette Beaker Ultra Sonic Cleaner Standard: Doxotylline working standard ‘Chemicals / Solvents / Solutions: Potassium Dihydragen Orthophosphaie (HPLC Grade) Water (HPLC or equivalent grade) Acetonitrile (HPLC Grade) Mobile phase: A filtered and degassed mixture of 800 volumes of buffer selution prepared by dissolving 6.8 of potassium dihydrogen orthophosphate in 1000 mi of water, and 200 volumes of acetonitrile, Sample solution preparation: ‘Accurately weigh and transfer about 40 mg of the substance to be examined in to a 100 ml volumetric flask. Add about 50 mi of mobile phase and sonicate to dissolve, Make up the volume upto the mark with mobile phase. Dilute 5 m! of this solution to 50 mi with mobile phase, Prepared By (06) Roviewed By (QC) Approved By (QA) os /ti jae oN gan Qty @, fagiileoy | FORMAT NO” GAOO2DUFIGp AAREY DRUGS & PHARMACEUTICALS LTD. E34, M,0.C,, Tarapur, Boisar - 401 S06, District Paighar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUCT | DGXOFYLLINE IH ; SPECIFICATIONNO, | PIFMS/GG/G01-00 _| EFFECTIVE DATE 05 NOV 2024 ‘OBSOLETE NO. NA NEXT REVIEW DATE PARTY NAME RENATA LIMITED PAGE NUMBER 12 OF 16 Standard solution preparation: ‘Accurately weigh and transfer about 40 mg of the Doxofylline working standard in to a 100 mi volumetric flask. Add about 50 mi of mobile phase and sonicate to dissolve. Make up the volume upto the mark with mobile phase, Dilute § mi of this solution to 50 ml with mobile phase. Chromatographic Conditions: The liquid chromatograph equipped with an UV detector, an injector and a data processor. Parameter | Standard condition Column C18 (25 om X 4.6mm), 5um particle size or Equivalent Flow rate 7.0 miimin Detection Wavelength | 274 nm injection volume Tul Run tine 15 minutes: Temperature Ambient Procedure: inject 10 ul each of blank solution (jn singlel), standard solution ((n five replicate), and sample solution (in duplicate). Run and record the peak corresponding to Doxafylline, System suitability: In reference solution, the test is not valid uniess the tailing factor is not more than 2.0, the column efficiency is not less than 2000 theoretical plates and the relative standard deviation for replicate injection is nat more than 2.0%. Prepared By (QC) J _ Reviewed By (QC) ‘Approved By (QA) od Ott esd ila 1g “asf )20%%y doer ne" FORMAT NO. QA002-01/F!1pee AAREY DRUGS & PHARMACEUTICALS LTD. = 34,[Link].C., Tarapur, Boisar — 401 808, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUCT DOXOFYLLINE 1H SPECIFICATION NO. | PIFMS/QC/001-00 EFFECTIVE DATE O05 NOV 2024 | OBSOLETE NO. [NA NEXT REVIEW DATE PARTY NAME [ RENATA LIMITED PAGE NUMBER 13 OF 16 Calculation: Calculate the percentage of assay on as is basis using the following formule. % Assay (0n dried basis) = Where, Ru= Average peak area of Doxalyiline in sample solution R.= Average peak area of Doxofyiline in standard solution. 1, = Dilution factor of standard solution Dé Dilution factor of sample solution. P = Potency of Doxofyliine working standard on as is basis. Calculate the percentage of assay on dried basis using the following formula. Assay on as Is b: (100-L00) % Assay an dried basis= ~ Acceptance Criteria: Not less than 98.5% and not more than 101.0% of CusHi«h«Ouon dried basis. Reviewed By (QC) i Approved By (QA) 9 1 4 im < shi) 20749 [= e g FORMAT NO.: QA002-01/F1-34,M..D.C,, Tarapur, Boisar — 401 806, District Paighar, Maharashtra pu AAREY DRUGS & PHARMACEUTICALS LTD. FINISH MATERIAL SPECIFICATION NAME OF PRODUGT | DOXOFYLLINE IH SPECIFICATION NO. | PIFMS/QC/OG1-00 | EFFECTIVE DATE 0s NOV 200 OBSOLETE NO. NA NEXT REVIEW DATE 04 OCT 2027 [PARTY NAME RENATALIMITED | PAGE NUMBER 14 OF 16 8. MELTING POINT Instrument / Apparatus: Melting Cum Boiling Point Apparatus Capillary tube (One end sea!) Procedure: Charge a capillary tube with a sufficient amount of the very fine dry powder (up te form 2.5 mmm to 3.5 mm of bettom of the capillary tube), capillary packed as closely as. possible by moderate tapping on solid surface. Operate the melting point apparatus &% per standard operating procedure. Heat the block until the temperature is about 10°C below the expected melting range. Insert the capillary tube inta the heating black, and continue heating at a rate of temperature increase of about 1°C to.2°C per minute until melting is complete. Report the temperature at which the substance starts collapsing against the capillary wall and the temperature at which the entire sample has gone in to liquid form Acceptance Criteria; between 142.0°C and 146.0°C Prepared By (QC) Reviewed By (QC) ‘Approved By(QA)_| a 2 «nk “ay i - astiilane req aoty wt" eA” FORMAT NO. GA002-01/F1pe AAREY DRUGS & PHARMACEUTICALS LTD. , E34, M1.D.C., Tarapur, Boisar — 401 $06, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION NAME OF PRODUCT | DOXOFYLLINE IH | SPECIFICATION NO. | PIFMSIQG/00T-00 EFFECTIVE DATE 05 Nov 202 | OBSOLETE NO. NA NEXTREVIEWOATE | 04 OCT 2027 PARTY NAME RENATALIMITED | PAGE NUMBER 15 OF 16 8. BULK DENSITY Instruments | Apparatus: Analytical Balance Bulk Density Apparatus Procedure: Bulk Density: weigh about 20 gm test substance (sample) and transter to 100 ml measuring cylinder. Note the volume of substance in cylinder. Calculation: ‘Weight of test substance taken (in gm) bulk density (g/m) ‘Acceptance Criteria: between 0.45giml to 0.88g/m! 10. SIEVE TEST Instruments / Apparatus: Analytical Balance Test Sieves Procedure: Volume of test substance in cylinder {in ml) Weigh 20 gm sample, Paur the sample entirety on the test sieve and shake the sieve manually for 3 set amount of time or till the sample has been passed totally through 80 mesh. Weigh the pass material collected. Calculate the percentage. Repeat the same procedure for 100 mesh. Acceptance Criteria: ‘80 mesh-5.0% retained maximum 100 mesh-10.0% retained maximum Prepared By (QC) Reviewed By (QC) ‘Approved By (GA) AEA iinow x Apo iciow FORMAT NO. QA002-01/F1Ope AAREY DRUGS & PHARMACEUTICALS LTD. 1-34, M..D.C., Tarapur, Bolsar — 401 608, District Palghar, Maharashtra FINISH MATERIAL SPECIFICATION [NAME OF PRODUGT | DOXOFYLLINE IH SPECIFIGATIONNO | PIFMS/QG/007-00 | EFFECTIVE DATE 05 NOV 202 ‘OBSOLETE NO. NA [NEXT REVIEW DATE 04 Or 27 PARTY NAME RENATALIMITED | PAGE NUMBER 16 OF 16 11, MICROBIAL LIMIT TEST Procedure: The test is performed by external laboratory Acceptance Criteria: Total Aerobic Microbial Count-not more than 1000 cfulg Total Combined Molds and Yeasts Count-not more than 100 cfulg Pathogens Escherichia Coll-absentig REVISION HISTORY | Revision ‘No. | Change Control No. | Reason for Change 00 = | new specification as per party (party specification) “END OF DOCUMENT*** Prepared By (QC) Reviewed By (QC) ‘Approved By (QA) i enti ostii lacey pfu 02y wl FORMAT NO: QA002-01/F1