DRUG DEVELOPMENT
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ANALYTICAL METHODS

Active Drug & Drug Product SI 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 5 new assays added each month.

Stability Indicating (S.I.) HPLC Assays
Uniformity of Content Assays
Dissolution Assays
Impurity Profiles

 
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REVIEW
A-255-2016 Diphenyhdramine + Phenylpropolamine
REVIEW
A-260-2016 Diphenyhdramine + Phenylpropolamine + Paracetamol
REVIEW
A-265-2016 Disopyramide
REVIEW
A-270-2016 Dorzolamide
REVIEW
A-275-2016 Doxazonsin mesylate
REVIEW
A-280-2016 Etodolic Acid/Etodolac (200,300,400 & 500 IR Tablets)
REVIEW
A-285-2016 Erdosteine
REVIEW
A-290-2016 Erythrocin in solid bases
REVIEW
A-295-2016 Erythromycin 250 + 500mg Tablets
REVIEW
A-300-2016 Etodolac ER 500, 600mg Tabs)
REVIEW
A-305-2016 Famoditine 10 20 + 40 mg Tablets
REVIEW
A-310-2016 Ferrous Gluconate Dihydrate (Atomic Absorption)
REVIEW
A-315-2016 Ferrous fumarate + Folic Acid
REVIEW
A-320-2016 Felodipine ER Tablets
REVIEW
A-325-2016 Fluconazole Capsules
REVIEW
A-330-2016 Fluconazole
REVIEW
A-335-2016 Fluvoxamine Capsules
REVIEW
A-340-2016 Fluocinolone acetonide (creams)
REVIEW
A-345-2016 Fluoxetine HCl 20, 40mg Capsules/Tablets
REVIEW
A-350-2016 Flurazepam Capsules
REVIEW
A-355-2016 Folic Acid
REVIEW
A-360-2016 FSH
REVIEW
A-365-2016 Furosemide 40mg Capsules/Tablets
REVIEW
A-370-2016 Fusidic acid
REVIEW
A-375-2016 Gabapentin (100/200/300/400mg) Capsules  
REVIEW
A-380-2016 Gemfibrosal 600mg Tablets  
REVIEW
A-385-2016 Glypizide 2,5, 5 10mg Tablets  
REVIEW
A-390-2016 Glucosamine Tablets  
REVIEW
A-395-2016 Granisetron HCl [ampules]  
REVIEW
A-400-2016 Guaiphenesin  
REVIEW
A-405-2016 Hydrocortizone/Benzocain/Allentoin  
REVIEW
A-410-2016 Ibuprofen 200, 400 + 800mg Tablets/Caplets  
REVIEW
A-415-2016 Indomethacin in Supp/Cap  
REVIEW
A-420-2016 Indigotine TLC ID
REVIEW
A-425-2016 Iron oxide in Gelatin Caps
REVIEW
A-430-2016 Isosorbide 5-mononitrate in 10-40 mg tabs
REVIEW
A-435-2016 Isosorbide Dinitrate
REVIEW
A-440-2016 Hydrocortizone/Benzocaine/Allantoin - semisolids
REVIEW
A-445-2016 Indomethasin in capsules
REVIEW
A-447-2016 Ofloxacin (100/200/400mg Tablets)  
REVIEW
A-450-2016 Omeprozole
REVIEW
A-455-2016 Oxaprozin 600mg Tablets
REVIEW
A-460-2016 Oxazepam Tablets
REVIEW
A-465-2016 Ketoprofen
REVIEW
A-470-2016 Ketorolac tromethamine 10 mg Tablets
REVIEW
A-475-2016 Lactulose
REVIEW
A-480-2016 Levodopa + Bensarazide 200/57mg
REVIEW
A-485-2016 Malathion (in Shampoo)
REVIEW
A-490-2016 Meclofenamic acid
REVIEW
A-495-2016 Medroxyprogesterone
REVIEW
A-500-2016 Mefenamic acid
REVIEW
A-505-2016 Mesalamine
REVIEW
A-510-2016 Metformin HCl 500, 850mg Tablets
REVIEW
A-515-2016 Methyl and carbidopa in tablets
REVIEW
A-520-2016 Metoprolol Tartrate
REVIEW
A-525-2016 Miconazole Nitrate in creams
REVIEW
A-530-2016 Muclobemide
REVIEW
A-535-2016 Mupirocin - (2% ointment)
REVIEW
A-540-2016 Nabumetone 500 + 750mg Tablets
REVIEW


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