List of Raw Material Active
List of Raw Material Active
List of Raw Material Active
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
and 10.5%.
LAI-011 Cetirizine Hydrochloride (Cetirizine BP-2012, P-457 Maximum 0.5 per cent,
Dihydrochloride) determined on 1.000 g
by drying in an oven at
105 C.
LAI-012 Cholecalciferol in Gelatin Coated Ph. Grade none
Granules 100000 IU/g USP-34, P-2324
Cholecalciferol (Vitamin D3)
LAI-013 Ciprofloxacin Hydrochloride USP-34, P-2343 Water determination,
(Ciprofloxacin Hydrochloride method (921): 4.7%-
Monohydrate) 6.7%
LAI-014 Cyanocobalamin 1.0 % Ph. Grade
Cyanocobalamin (Vitamin B12) BP-2012, P-619
LAI-015 Diclofenac Sodium Pellets Ph. Grade Maximum 0.5 per cent,
Diclofenac Sodium BP-2012, P-688 determined on 1.000 g
by drying in an oven at
105 C for 3 h.
LAI-016 Domperidone (Micronized) BP-2012, P-756
LAI-017 Domperidone Maleate BP-2012, P-758 Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C
LAI-018 Losartan Potassium USP-34, P-3342 Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C.
LAI-019 Naproxen BP-2012, P-1523 Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C for 3 h.
LAI-020 Omeprazole Pellets Ph. Grade Maximum 0.2 per cent,
Omeprazole BP-2012, P-1599 determined on 1.000 g
by drying under high
vacuum at 60 C for 4
h
LAI-021 Pyridoxine Hydrochloride (Vitamin B6) BP-2012, P-1857 Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C.
LAI-022 Ranitidine Hydrochloride USP-34, P-4120 Dry it in vacuum at 60
C for 3 hours: it loses
not more than 1.75 % of
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
its weight.
LAI-023 Sulfamethoxazole BP-2012, P-2074 Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C.
LAI-024 Thiamine Nitrate (Vitamin B1) BP-2012, P-2140 Maximum 1.0 per cent,
determined on 1.000 g
by drying in an oven at
105 C
LAI-025 Trimethoprim BP-2012, P-2228 Maximum 1.0 per cent,
determined on 1.000 g
by drying in an oven at
105 C.
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
105 C for 5 h.
LAI-045 Metronidazole BP-2012, P-1464 Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C for 3 h.
LAI-046 Nicotinamide BP-2012, P-1539 Not more than 0.5 per
cent, determined on
1.00 g by drying in
vacuo for 18 h.
LAI-047 Pantoprazole Sodium (Pantoprazole USP-34, P-3810 5.9 per cent to 6.9 per
Sodium Sesquihydrate) cent, determined on
0.150 g.
LAI-048 Paracetamol BP-2012, P-1657 When dried to constant
weight at 105, loses
not more than 0.5% of
its weight. Use 1 g.
LAI-049 Riboflavin Sodium Phosphate BP-2012, P-1893 Maximum 8.0 per cent,
determined on 1.000 g
by drying in an oven at
105 C at a pressure
not exceeding 0.7 kPa
for 5 h
LAI-050 Sildenafil Citrate INN
LAI-051 Tadalafil INN
LAI-052 Thiamine Hydrochloride BP-2012, P-2138 Maximum 5.0 per cent,
determined on 0.40 g.
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
105 C for 3 h
LAI-058 Cefaclor USP-34 Water determination,
method (921): between
3.0% and 6.5%
LAI-059 Cefuroxime Axetil USP-34, p-2251 Water determination,
method (921):not more
than 1.5%.
LAI-060 Clindamycin Hydrochloride BP-2013 3.0 per cent to 6.0 per
cent, determined on
0.500 g.
LAI-061 DL-Methionine BP-2013 Not more than 0.5 per
cent, determined on
1.000 g by drying in an
oven at 105 C.
LAI-062 Esomeprazole Magnesium Pellets 22.50 Ph. Grade Water determination,
% USP-34 method (921): 6.0%-
Esomeprazole Magnesium 8.0%
trihydrate
LAI-063 Esomeprazole Magnesium Pellets 8.50 % Ph. Grade Water determination,
Esomeprazole Magnesium USP-34, p-2741 method (921): 6.0%-
trihydrate 8.0%
LAI-064 Flupentixol Hydrochloride (Flupentixol BP-2013 Maximum 2.0 per cent,
Dihydrochloride) determined on 1.000 g
by drying in an oven at
105 C
LAI-065 Ketotifen Fumarate BP-2013 Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C for 4 h
LAI-066 Melitracen Hydrochloride INN
LAI-067 Montelukast Sodium INN
LAI-068 Nitazoxanide INN
LAI-069 Ondansetron Hydrochloride Dihydrate BP-2013 9.0 per cent to 10.5 per
cent, determined on
0.200 g
LAI-070 Rabeprazole Sodium INN
LAI-071 Rupatadine Fumarate INN
LAI-072 Tamsulosin HCl 0.20% Pellets Ph. Grade Usp-none
Tamsulosin Hydrochloride USP-34 P-4333
LAI-073 Gliclazide BP-2013 Maximum 0.25 per cent,
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
determined on 1.000 g
by drying in an oven at
105 C for 2 h.
LAI-074 Potassium Bicarbonate BP-2013 none
LAI-075 Sodium Alginate BP-2013 Maximum 15.0 per cent,
determined on 0.1000 g
by drying in an oven at
105 C for 4 h
LAI-076 Ceftriaxone Sodium (Sterile) USP-34 Water determination,
method (921): between
8.0% and 11.0%.
LAI-077 Clavulanate Potassium USP-34, p-2366 Water determination,
method (921): not more
than 1.5%.
LAI-078 Cyanocobalamin (B12) (Injectable BP-2013 Maximum 12.0 per cent,
grade) determined on 20.00
mg by drying in vacuo
at 105 C for 2 h.
LAI-079 Flucloxacillin Sodium (Compacted) BP-2013 3.0 per cent to 4.5 per
cent, determined on
0.300 g
LAI-080 Flucloxacillin Sodium (Micronized) BP-2013
1.000 g by drying in an
oven at 105 C.
LAI-088 Aspirin USP Dry it over silica gel
for 5 hours:it loses
not more than0.5% of
its weight.
LAI-089 Betacarotine BP none
LAI-090 Biotin BP Not more than 1.0 per
cent, determined on
1.000 g by drying in an
oven at 105 C
LAI-091 Bisoprolol Fumarate BP Maximum 0.5 per cent,
determined on 1.000 g
LAI-092 Boron Citrate 5 % Ph. Grade
LAI-093 Calcium Lactate BP Maximum 3.0 per cent,
determined on 0.500 g
by drying in an oven at
125 C
LAI-094 Calcium Pantothenate BP Not more than 3.0 per
cent, determined on
1.000 g by drying in an
oven at 105 C
LAI-095 Calcium Phosphate BP Maximum 8.0 per cent,
determined on 1.000 g
by ignition at 800 50
C for 30 min.(L.I)
LAI-096 Choline Bitartrate Ph. Grade Usp-none
LAI-097 Chromic Chloride Hexahydrate USP, p-2327 none
LAI-098 Chromium Polynicotinate Ph. Grade Usp-none
LAI-099 Clopidogrel Bisulfate USP, P-2401 Dry it at 105C for 2
hours: it loses not
more than 0.5% of its
weight.
LAI-100 Cod Liver Oil BP
LAI-101 Colecalciferol (Vitamin D) BP Maximum 2.0 per cent,
determined on 1.000 g
by drying in an oven at
200 10 C
LAI-102 Copper (II) Oxide Ph. Grade
LAI-103 Dried Ferrous Sulphate BP none
LAI-104 Inositol Ph. Grade
LAI-105 Lutein 5 % Ph. Grade
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
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Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
0.200 g.
LAI-127 Magaldrate USP, p-3355 Dry it at 200 C for 4
hours: itloses between
10.0% and 20.0% of its
weight.
LAI-128 Salbutamol Sulfate BP Maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C
LAI-129 Simethicone USP P-4225 Usp-none
LAI-130 Citric Acid Monohydrate USP P-2358 Water determination
method (921): 7.5%-
9.0%
LAI-131 Lactulose Solution BP none
LAI-132 Moxifloxacin Hydrochloride USP p-3567 Water determination
method (921): not
more than 4.5%
LAI-133 Trimetazidine Dihydrochloride BP Maximum 2.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C over
diphosphorus pentoxide
R at a pressure not
exceeding 15 kPa.
_______________
Fazlul Haq
Asst. Manager, QC.
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