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IAGIM - Drug Development Association


IAGIM - Analytical Methods - Page 3


Active Drug & Drug Product S.I. Assay List

Fully Qualified Validated Stability Indicating (S.I.) HPLC Assays and Impurity Profiles for Product Development; Process Qualification; Pivotal & Validation Studies (Also Dissolution & Uniformity of Content Assays - in HPLC, GC & UV as required) - Up to 10 new assays added each month
A-545-2015 Naproxen + Naproxen Na - REVIEW
A-550-2015 Naphazoline (in nasal drops)   REVIEW
A-555-2015 Nefazodone HCl   REVIEW
A-560-2015 Nifedipine & NPO   REVIEW
A-565-2015 Nimodipine   REVIEW
A-570-2015 Nitrenpidine   REVIEW
A-575-2015 Norfloxacin nicotinate 400mg Tablets   REVIEW
A-580-2015 Paclitaxel + 7-epipaclitaxel   REVIEW
A-585-2015 Paclitaxel 6mg/mL 30, 100 300mg vials (Concentrate Inj)   REVIEW
A-590-2015 Parabans in solids + Parabans semisolid bases   REVIEW
A-600-2015 Paracetamol + Propoxyphene   REVIEW
A-605-2015 Paracetamol + Phenylpropolamine   REVIEW
A-610-2015 Paracetamol + Papaverine + Cod Phos.   REVIEW
A-615-2015 Paracetamol + Vitamin C   REVIEW
A-620-2015 Pentoxifylline 400mg (ER Tabs)   REVIEW
A-625-2015 Pentoxifylline (IR Tabs)   REVIEW
A-630-2015 Prindol   REVIEW
A-635-2015 Piracetam   REVIEW
A-640-2015 Piroxicam 10, 20mg   REVIEW
A-645-2015 Phenylephedrine & benzalkonium Cl   REVIEW
A-650-2015 Phenylephedrine & Codeine Phosphate   REVIEW
A-655-2015 Potassium Chloride 1200mg SR Capsules (HPLC)   REVIEW
A-660-2015 Prednisolone   REVIEW
A-665-2015 Propranolol   REVIEW
A-670-2015 Pseudoephedrine HCl & Diphenyhdramine   REVIEW
A-675-2015 Pseudoephedrine HCl & Dexchlorpheniramine   REVIEW
A-680-2015 Pyridoxine HCl   REVIEW
A-685-2015 Quinidine Bisulphate Tetrahydrate   REVIEW
A-690-2015 Ranitidine Chromographic Purity   REVIEW
A-695-2015 Selegiline HCl 5mg Tablets   REVIEW
A-700-2015 Simvastatin 10,20,40mg Tablets   REVIEW
A-705-2015 Sodium Glycerophosphate + Nicotinic acid   REVIEW
A-710-2015 Sotalol 80160 & 240mg Tablets   REVIEW
A-715-2015 Sparfloxacin   REVIEW
A-720-2015 Sulindac   REVIEW
A-725-2015 Sulphamethoxozole & Trimethoprim   REVIEW
A-730-2015 Tamoxifen Citrate 10, 20, 30, 40mg Tablets (US)   REVIEW
A-735-2015 Tamoxifen Citrate 10, 20, 30, 40mg Tablets (UK/EC)   REVIEW
A-740-2015 Terazosin HCl   REVIEW
A-745-2015 Terbinafine Caplets 250mg   REVIEW
A-750-2015 Terbutalin   REVIEW
A-755-2015 Terfenadine   REVIEW
A-760-2015 Tetracycline HCl   REVIEW
A-765-2015 Ticlopidone   REVIEW
A-770-2015 Timolol maleate   REVIEW
A-775-2015 Titanium Dioxide in Gelatin   REVIEW
A-780-2015 Tolmetin Sod.   REVIEW
A-785-2015 Tramadol HCl   REVIEW
A-790-2015 Trazodone 50, 100 & 150mg Tablets   REVIEW
A-795-2015 Trimellitic esters (in Rubber Stoppers)   REVIEW

New assays added each month

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