DRUG DEVELOPMENT
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ANALYTICAL METHODS

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 5 new assays added each month

 

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

A-545-2016 Naproxen + Naproxen Na
-
REVIEW
A-550-2016 Naphazoline (in nasal drops)
REVIEW
A-555-2016 Nefazodone HCl
REVIEW
A-560-2016 Nifedipine & NPO
REVIEW
A-565-2016 Nimodipine
REVIEW
A-570-2016 Nitrenpidine
REVIEW
A-575-2016 Norfloxacin nicotinate 400mg Tablets
REVIEW
A-580-2016 Paclitaxel + 7-epipaclitaxel
REVIEW
A-585-2016 Paclitaxel 6mg/mL 30, 100 300mg vials (Concentrate Inj)
REVIEW
A-590-2016 Parabans in solids + Parabans semisolid bases
REVIEW
A-600-2016 Paracetamol + Propoxyphene
REVIEW
A-605-2016 Paracetamol + Phenylpropolamine
REVIEW
A-610-2016 Paracetamol + Papaverine + Cod Phos.
REVIEW
A-615-2016 Paracetamol + Vitamin C
REVIEW
A-620-2016 Pentoxifylline 400mg (ER Tabs)
REVIEW
A-625-2016 Pentoxifylline (IR Tabs)
REVIEW
A-630-2016 Prindol
REVIEW
A-635-2016 Piracetam
REVIEW
A-640-2016 Piroxicam 10, 20mg
REVIEW
A-645-2016 Phenylephedrine & benzalkonium Cl
REVIEW
A-650-2016 Phenylephedrine & Codeine Phosphate
REVIEW
A-655-2016 Potassium Chloride 1200mg SR Capsules (HPLC)
REVIEW
A-660-2016 Prednisolone
REVIEW
A-665-2016 Propranolol
REVIEW
A-670-2016 Pseudoephedrine HCl & Diphenyhdramine
REVIEW
A-675-2016 Pseudoephedrine HCl & Dexchlorpheniramine
REVIEW
A-680-2016 Pyridoxine HCl
REVIEW
A-685-2016 Quinidine Bisulphate Tetrahydrate
REVIEW
A-690-2016 Ranitidine Chromographic Purity
REVIEW
A-695-2016 Selegiline HCl 5mg Tablets
REVIEW
A-700-2016 Simvastatin 10,20,40mg Tablets
REVIEW
A-705-2016 Sodium Glycerophosphate + Nicotinic acid
REVIEW
A-710-2016 Sotalol 80160 & 240mg Tablets
REVIEW
A-715-2016 Sparfloxacin
REVIEW
A-720-2016 Sulindac
REVIEW
A-725-2016 Sulphamethoxozole & Trimethoprim
REVIEW
A-730-2016 Tamoxifen Citrate 10, 20, 30, 40mg Tablets (US)
REVIEW
A-735-2016 Tamoxifen Citrate 10, 20, 30, 40mg Tablets (UK/EC)
REVIEW
A-740-2016 Terazosin HCl
REVIEW
A-745-2016 Terbinafine Caplets 250mg
REVIEW
A-750-2016 Terbutalin
REVIEW
A-755-2016 Terfenadine
REVIEW
A-760-2016 Tetracycline HCl
REVIEW
A-765-2016 Ticlopidone
REVIEW
A-770-2016 Timolol maleate
REVIEW
A-775-2016 Titanium Dioxide in Gelatin
REVIEW
A-780-2016 Tolmetin Sod.
REVIEW
A-785-2016 Tramadol HCl
REVIEW
A-790-2016 Trazodone 50, 100 & 150mg Tablets
REVIEW
A-795-2016 Trimellitic esters (in Rubber Stoppers)
REVIEW


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