Bureau of Laboratory Quality Standards Page 1 of 10
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1 1. Ceftriaxone sodium sterile - Cef-3 Inj. (250-IM) - Cef-3 Inj. (250-IV) - Cef-3 Inj. (500-IM) - Cef-3 Inj. (500-IV) - Cef-3 Inj. (1 g -IM) - Cef-3 Inj. (1 g IV) - Cef-3 Inj. (2 g IV) 2. Ceftazidime pentahydrate Buffer (sodium carbonate) - Cef mg Inj. - Cef-4 1 g Inj. - Appearance & potency - ph - Water content - Crystallinity - Constituted solution - Appearance & Potency - ph - Loss on drying - Pyridine content - Constituted solution - Sodium carbonate content Bureau of Laboratory Quality Standards Page 1 of 10
2 3. Cefotaxime sodium sterile - Claraxim 0.5 gm Inj. - Claraxim 1.0 gm Inj. 4. Acyclovir - Vilerm 200 mg Tablet - Vilerm 400 mg Tablet - Vilerm 800 mg Tablet - Appearance - Acidity - Clarityof solution - Loss on drying BP Related substance (Weight variation) - Related compounds * Guanine * Any other impurity Bureau of Laboratory Quality Standards Page 2 of 10
3 5. Enalapril maleate - Nalopril 5 mg Tablet - Nalopril 10 mg Tablet - Nalopril 20 mg Tablet 6. Cefoperazone Sodium and Sulbactam Sodium Injection - Sulcef Inj. (1.0 g) - Sulcef Inj. (1.5 g) (Content Uniformity) - Related compounds (Total) & potency In-house method WI-QC-TM-01 by - Chromatographic purity HPLC technique (Content Uniformity) - ph (25% solution) - Water content - Constituted solution Bureau of Laboratory Quality Standards Page 3 of 10
4 7. Isosorbide dinitrate (diluted) - Hartsorb 5 mg Tablet (Sublingual) - Hartsorb 10 mg Tablet - Hartsorb 30 mg Tablet 8. Simvastatin - Lochol 10 mg Tablet - Lochol 20 mg Tablet - Lochol 40 mg Tablet - Lochol 80 mg Tablet 9. Sterile water for injection - SWFI 2 ml - SWFI 4 ml - SWFI 5 ml - SWFI 10 ml (Content Uniformity) - Disintegration (for 5 mg only) USP 36/NF 31: 2013 (Modified; Not use internal standard) (Content Uniformity) - Disintegration - Oxidizable substance - ph - Water conductivity - Volume in container Bureau of Laboratory Quality Standards Page 4 of 10
5 10. Meropenem injection - Mapenem 0.5 g injection - Mapenem 1.0 g injection 11. Finasteride Tablet - Firide 1 mg Tablet - Firide 5 mg Tablet 12. Losartan Potassium Tablet - Losartan 50 mg Tablet - Losartan 100 mg Tablet Meropenem - ph - Loss on drying - Content of sodium - Chromatographic purity - Constituted solution USP 34/NF 29: Organic impurities: -1H Dimer -2H Dimer Bureau of Laboratory Quality Standards Page 5 of 10
6 13. Fexofenadine HCl Tablet - Vifas 60 mg Tablet 14. Amoxicillin and Clavulanate Potassium Tablet - Cavumox Tablet (375 mg) - Cavumox Tablet (625 mg) - Cavumox Tablet (1 g) - Organic impurities: - Fexofenadine related compound A - Decarboxylated degradant - Any individual other impurity - Total impurities for Amoxicillin for Clavulanic acid for Amoxicillin for Clavulanic acid test for Amoxicillin test for Clavulanic acid for Amoxicillin for Clavulanic acid - Water determination Bureau of Laboratory Quality Standards Page 6 of 10
7 15. Omeprazole (for) injection - O-Sid injection In-house Method WI-QC-TM-01 Sterile Average weight per vial In-house Method WI-QC-TM-01 by - Range of mean weight - Related substance: - Individual impurity - Total impurities In-house Method WI-QC-TM-01 Sterile ph - Constituted solution - Water content 16. Powder Injection* 17. Liquid Injection** 18. Lyophyllized Injection*** USP 37/NF 32: Eye Drop**** 20. Aqueous preparation for oral use drug product***** - Total aerobic microbial count (TAMC) - Total combined yeasts/ molds count (TYMC) - Escherichia coli - Salmonella spp. USP 37/NF 32: 2014 Bureau of Laboratory Quality Standards Page 7 of 10
8 21. Topical preparation for intact skin drug product****** Note - Total aerobic microbial count (TAMC) - Total combined yeasts/ molds count (TYMC) - staphylococcus aureus - Pseudomonas aeruginosa Powder Injection* 1. Cavumox 1.2 g (Amoxicillin sodium + Clavulanic acid) 2. Cavumox 0.6 g (Amoxicillin sodium + Clavulanic acid) 3. Fazolin (Cefazolin sodium) 4. Cefxitin (Cefoxitin sodium) 5. Furoxime (Cefuroxime sodium) 6. Sulam (Cefoperazone sodium + Sulbactam sodium) (1.5g, 3 g) 7. Cloxalin inj. (Cloxacillin sodium) 8. Fosfomin inj. (Fosfomycin)(1g, 2g) 9. Mellistin inj 10. Cavumox inj (2.2 g) Liquid Injection** 1. Dosanac (Diclofenac sodium) 2. Furetic S (Furosemide sodium) 3. Inopin (Dopamine HCl) 4. Nausil (Metoclopramide HCl) 5. Onsia (Ondansetron HCl) 6. Zantidon (Ranitidine HCl) USP 37/NF 32: 2014 Bureau of Laboratory Quality Standards Page 8 of 10
9 Liquid Injection** 7. Lidocaine HCl 1% (Lidocaine HCl) 8. Solvent for O-Sid (Polyethylene Glycol 400) 9. Flucozole (Fluconazole) 10. Glyceol (Glycerine) 11. Rosil inj. (Clindamycin phosphate) 12. Siamidine inj. (Cimetidine HCl) 13. Sipam inj. (Diazepam) 14. Zolennic concentrate (Zoledronic acid) 15. Metrolex inj. 16. Cifloxin inj. 17. Lefloxin inj. 18. Lingo inj. 19. Grammicin inj. 20. Grammicin Pediatric inj. 21. Netil inj. Lyophyllized Injection*** 1. Vilerm Inj. (Acyclovir Sodium) (250 mg) 2. Vilerm Inj. (500 mg) Eye Drop**** 1. Antazallerge ED (Antazoline HCl + Tetrahydrozoline HCl) 2. Chloracil ED (Chloramphenicol) 3. Eyedex ED (Dexamethasone + Neomycin) Bureau of Laboratory Quality Standards Page 9 of 10
10 Aqueous preparation for oral use drug product ***** 1. A-mol syrup 2. A-mol suspension 3. A-mol Ped Syrup 4. Ulcefate suspension 5. Histan syrup 6. Heidi suspension 7. Lorsedin oral solution Topical preparation for intact skin drug product ****** 1. Ketazon shampoo Bureau of Laboratory Quality Standards Page 10 of 10
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