List of Raw Material Active

Leon Pharmaceuticals Limited
QUALITY CONTROL DEPARTMENT
5. List of Raw Material Active
Code No. Material Name Specification LOD

LAI-001 Aceclofenac BP-2012, P-46 maximum 0.5 per cent,
determined on 1.000 g
by drying in an oven at
105 C.
LAI-002 Ambroxol Hydrochloride BP-2012, P-121 Maximum 0.5 per cent,
105 C.
LAI-003 Amlodipine Besilate BP-2012, P-142 Maximum 0.5 per cent,
determined on 1.000 g.
LAI-004 Atenolol BP-2012, P-189
LAI-005 Azithromycin Dihydrate USP-34, P-1965 1.8 per cent to 6.5 per
(Crystalline/Compacted) cent, determined on
0.200 g.
LAI-006 Calcium Carbonate USP-34, P-2127 Dry it at 200 C for 4
hours. It loses not more
than 2.0% of its weight.
LAI-007 Cefixime (Compacted) USP-34, P-2220 Water method
(Cefixime Trihydrate) (921):between 9.0%
and 12.0%
LAI-008 Cefixime (Micronized) USP-34, P-2220 Water method
(Cefixime Trihydrate) (921):between 9.0%
and 12.0%
LAI-009 Cephradine (Compacted) USP-34, P-2266 Dry out 100 mg,
accurately weighed, of
the mixed contents of 4
capsules in a capillary
stoppered bottle in
vacuum at a pressure
not exceeding 5mm of
mercury at 60 for 3
hours: the capsule
contents lose not more
than 7.0% of their
weight.
LAI-010 Cephradine (Micronized) USP-34, P-2266 Water, method (921):
not more than 6.0%,
except that if it is the
dehydrate form, the
limit is between 8.5%
Page 1 of 11
and 10.5%.
LAI-011 Cetirizine Hydrochloride (Cetirizine BP-2012, P-457 Maximum 0.5 per cent,
Dihydrochloride) determined on 1.000 g
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
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,
105 C
LAI-018 Losartan Potassium USP-34, P-3342 Maximum 0.5 per cent,
105 C.
LAI-019 Naproxen BP-2012, P-1523 Maximum 0.5 per cent,
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,
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
Page 2 of 11
its weight.
LAI-023 Sulfamethoxazole BP-2012, P-2074 Maximum 0.5 per cent,
105 C.
LAI-024 Thiamine Nitrate (Vitamin B1) BP-2012, P-2140 Maximum 1.0 per cent,
105 C
LAI-025 Trimethoprim BP-2012, P-2228 Maximum 1.0 per cent,
105 C.
Code No. Material Name Specification

LAI-026 Azithromycin Dihydrate (Micronized) USP-34, P-1965 Where it is labeled as
azithromycin
monohydrate and has a
water content of 4.0%-
6.5%
LAI-027 Albendazole (Compacted) USP-34, P-1771 Dry it at 105 C for 4
hours; it loses not more
LAI-028 Albendazole (Micronized) USP-34, P-1771 Dry it at 105 C for 4
hours; it loses not more
LAI-029 Atorvastatin Calsium Trihydrate BP-2013 3.5 per cent to 5.5 per
cent, determined on
0.130 g.
LAI-030 Baclofen BP-2012, P-216 Maximum 1.0 per cent,
LAI-031 Caffeine BP-2012, P-327
LAI-032 Carbonyl Iron INN + Folic Acid + Zinc Ph. Grade USP-none
Sulphate Monohydrate Blended Pellets INN
Carbonyl Iron
BP-2012, P-963
Folic Acid
Zinc Sulphate USP-34, P-4629
Monohydrate(Zinc Sulphate
Monohydrate)
LAI-033 Cefadroxil Monohydrate USP-34, P-2202 Water method (921):
between 4.2% and
Page 3 of 11
6.0%,except that where

it is labeled as being in
the hemihydrates form
it is between 2.4% and
4.5%.
LAI-034 Cefpodoxime Proxetil USP-34, P-2240 Water method (921):
not more than 3.0%.
LAI-035 Ciprofloxacin Taste Mask Granules (20% Ph. Grade Water determination
Ciprofloxacin) USP-34, P-2343 method (921): 4.7%-
Ciprofloxacin Hydrochloride 6.7%
(Ciprofloxacin Hydrochloride
Monohydrate)
LAI-036 Desloratidine INN
LAI-037 Esomeprazole Magnesium USP-34, P-2741 Water determination,
(Esomeprazole Magnesium Trihydrate) method (921): 6.0%-
8.0%.
LAI-038 Fexofenadine Hydrochloride USP-34, P-2823 Water determination,
(Crystalline/Compacted) method (921): not more
than 2.0% for the
anhydrous form,
between 6.0% and 10.0
%for the hydrate form.
LAI-039 Fluconazole USP-34, P-2840 Dry it at 105% for 3
hours: it loses not more
LAI-040 Folic Acid BP-2012, P-963 5.0 per cent to 8.5 per
cent, determined on
0.150 g.
LAI-041 Hydrochlorothiazide BP-2012, P-1078 Maximum 0.5 per cent,
105 C.
LAI-042 Ketorolac tromethamine USP-34, P-3251 Maximum 0.5 per cent,
by drying in vacuo at 60
C for 3 h.
LAI-043 Levofloxacin (Levofloxacin USP-34, P-3296 Water determination,
Hemihydrate) method (921): 2.1%-
2.7%
LAI-044 Metformin Hydrochloride BP-2012, P-1414 Maximum 0.5 per cent,
Page 4 of 11
105 C for 5 h.
LAI-045 Metronidazole BP-2012, P-1464 Maximum 0.5 per cent,
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,
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,

LAI-053 Tiemonium Methyl Sulphate INN
LAI-054 Tramadol Hydrochloride BP-2012, P-2191 Maximum 0.5 per cent,
LAI-055 Zinc Sulfate (Zinc Sulfate Monohydrate) USP-34, P-4629 none
LAI-056 Fexofenadine Hydrochloride USP-34, P-2823 Water determination,
(Micronized) method (921): not more
than 2.0% for the
anhydrous form,
between 6.0% and 10.0
%for the hydrate form
LAI-057 Naproxen Sodium BP-2013 Maximum 1.0 per cent,
Page 5 of 11
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
105 C
LAI-065 Ketotifen Fumarate BP-2013 Maximum 0.5 per cent,
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,
Page 6 of 11
105 C for 2 h.
LAI-074 Potassium Bicarbonate BP-2013 none
LAI-075 Sodium Alginate BP-2013 Maximum 15.0 per cent,
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

LAI-081 Ketorolac Tromethamine (Injectable USP-34
grade)
LAI-082 Ondansetron Hydrochloride BP-2013 9.0 per cent to 10.5 per
Dihydrate (Injectable grade) cent, determined on
0.200 g.
LAI-083 Pyridoxine Hydrochloride ((B6) BP-2013 Maximum 0.5 per cent,
(Injectable grade) determined on 1.000 g
105 C
LAI-084 Thiamine Hydrochloride (B1) BP-2013 Maximum 5.0 per cent,
(Injectable grade) determined on 0.40 g.
LAI-085 Alpha Tocopheryl Acetate (Vitamin BP none
E)
LAI-086 Anhydrous Colloidal Silica BP Maximum 5.0 per cent,
by drying in vacuo at
105 C
LAI-087 Ascorbic Acid (Vitamin C) BP Not more than 0.5 per
cent, determined on
Page 7 of 11
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
oven at 105 C
LAI-091 Bisoprolol Fumarate BP Maximum 0.5 per cent,
LAI-092 Boron Citrate 5 % Ph. Grade
LAI-093 Calcium Lactate BP Maximum 3.0 per cent,
125 C
LAI-094 Calcium Pantothenate BP Not more than 3.0 per
cent, determined on
oven at 105 C
LAI-095 Calcium Phosphate BP Maximum 8.0 per cent,
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,
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
Page 8 of 11
LAI-106 Magnesium Lactate Ph. Grade

LAI-107 Magnesium Oxide BP Maximum 0.5 per cent,
by drying in vacuo at
100 C for 4 h.
LAI-108 Manganese Gluconate USP-34, P-3378 Water determination,
method (921): (where
labeled as the dried
form): between 3.0%
and 9.0% the
determination being
performed by stirring
the mixture containing
the test preparation,
maintained at a
temperature of 50 C,
for 30 minutes before
titrating with the
reagent: where labeled
as the dehydrate it is
between 6.0 and 9.0%
LAI-109 Manganese Sulphate Monohydrate Ph. Grade Water determination,
method (921): (where
labeled as the dried
form): between 3.0%
and 9.0% the
determination being
performed by stirring
the mixture containing
the test preparation,
maintained at a
temperature of 50 C,
for 30 minutes before
titrating with the
reagent: where labeled
as the dehydrate it is
between 6.0 and 9.0%
LAI-110 Niacin (Nicotinic Acid) USP, p-3649 Dry it at 105 C for 1
hour: it loses not
more than 1.0% of its
weight.
LAI-111 Nickel (II) Sulphate Ph. Grade
Page 9 of 11
LAI-112 Para Amino Benzoic Acid (PABA) Ph. Grade

LAI-113 Potassium Chloride BP When dried at 70 at a
pressure not exceeding
0.7 kPa for 16 hours,
loses not more than
8.0% of its weight. Use
2 g.
LAI-114 Potassium Citrate USP Dry it at 180 C for 4
hours: it loses between
3.0% and 6.0% of its
weight.
LAI-115 Potassium Iodide BP When dried to constant
weight at 105, loses
not more than 8.0% of
its weight. Use 1 g.
LAI-116 Selenomethionine USP Usp-none
LAI-117 Sodium Metavandate Ph. Grade
LAI-118 Sodium Molybdate Dihydrate BP 14.0 per cent to 16.0
per cent, determined on
oven at 140 C for 3 h.
LAI-119 Sodium Selenate Ph. Grade
LAI-120 Stannous Chloride Ph. Grade
LAI-121 Vitamin A Propionate BP Maximum 0.5 per cent,
105 C for 3 h.
LAI-122 Vitamin A Retinol Palmitate BP none
LAI-123 Vitamin K BP Not more than 0.5 per
cent, determined on
1.000 g by drying over
diphosphorus
pentoxide R at a
pressure of 2 kPa to 3
kPa for 4 h.
LAI-124 Zinc Gluconate USP Water method (921):
NOT MORE THAN
11.6%
LAI-125 Zinc Oxide BP Maximum 1.0 per cent,
by ignition to constant
mass at 500 50 C.
(LI)
LAI-126 Dextromethorphan Hydrobromide BP 4.0 per cent to 5.5 per
cent, determined on
Page 10 of 11
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,
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,
105 C over
diphosphorus pentoxide
R at a pressure not
exceeding 15 kPa.
_______________
Fazlul Haq
Asst. Manager, QC.
Page 11 of 11

List of Raw Material Active

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Leon Pharmaceuticals Limited

QUALITY CONTROL DEPARTMENT

5. List of Raw Material Active

Code No. Material Name Specification LOD

5. List of Raw Material Active

5. List of Raw Material Active

Code No. Material Name Specification

5. List of Raw Material Active

6.0%,except that where

5. List of Raw Material Active

Code No. Material Name Specification

5. List of Raw Material Active

5. List of Raw Material Active

Code No. Material Name Specification

5. List of Raw Material Active

5. List of Raw Material Active

LAI-106 Magnesium Lactate Ph. Grade

5. List of Raw Material Active

LAI-112 Para Amino Benzoic Acid (PABA) Ph. Grade

5. List of Raw Material Active

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