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Reference And Working Standards For Good Pharmaceutical Products

Reference standards are one of the key factors for consistently good quality of Pharmaceutical Products. They are used as Primary or Secondary standards for the quality control of Active Pharmaceutical Ingredients (API) and Finished Products.

Quality Control in our Laboratory is responsible for testing 227 Active Pharmaceutical Ingredients (API) and Finished Products produced by Manufacturers. For the analyses of this number of different substances and products, we are handling with Sophisticated Instruments like High-Performance Liquid Chromatography with Auto-sampling System & Gas Chromatography with Head Space with skilled and trained personnel.

Within Tamilnadu Test House, chemical reference standards are centrally managed and coordinated by a controlling manager with decentralized analytical testing by laboratory experts. Linked to their routine use, four types of RS are defined: Primary standards (PS) and Working Standards (WS) for content and identity determinations, Reference Materials (RM) for identification purposes and system suitability testing, and Official Standards (OS) for both, depending on the user-defined by the compendia.

The declared content of PS is calculated on an as-is basis taking all-determining components into account. The same procedure is applied for WS (if purity >98%) in order to minimise the propagation of errors. The calculated result is verified vs. a content determination using a PS or compendia standard, or an absolute content method.

S.No.Name of the MaterialID No.
1AceclofenacTNTH/P/WS-001
2N. Acetyl CresterineTNTH/P/WS-002
3AciclovirTNTH/P/WS-003
4Amoxycillin TrydrateTNTH/P/WS-004
5Atorvastatin CalsiumTNTH/P/WS-005
6Ambroxol HCLTNTH/P/WS-006
7AzithromycinTNTH/P/WS-007
8Ascorbic Acid CoatedTNTH/P/WS-008
9AmoxicillinTNTH/P/WS-009
10AmbroxolTNTH/P/WS-010
11Azithromycin dydrateTNTH/P/WS-011
12L. AcetylTNTH/P/WS-012
13L. CystineTNTH/P/WS-013
14AcebrofyllineTNTH/P/WS-014
15AcebrofyllineTNTH/P/WS-015
16Amitryphyline HCLTNTH/P/WS-016
17N- Acetyl L- CysteineTNTH/P/WS-017
18N- Acetyl cysteineTNTH/P/WS-018
19Dried Aluminium HydroxideTNTH/P/WS-019
20BronopolTNTH/P/WS-020
21Benidine HCL WSTNTH/P/WS-021
22Butylated hydroxy TolueneTNTH/P/WS-022
23Bromhexine HCLTNTH/P/WS-023
24BenfortiamineTNTH/P/WS-024
25Buclitine HCLTNTH/P/WS-025
26Cetostearyl AlcoholTNTH/P/WS-026
27ClotrimazoleTNTH/P/WS-027
28Cyproheptadine HCLTNTH/P/WS-028
29CyproheptadineTNTH/P/WS-029
30Chromium PicolinateTNTH/P/WS-030
31CetriximeTNTH/P/WS-031
32Clindamycin HCLTNTH/P/WS-032
33Clostimethate SodiumTNTH/P/WS-033
34Crosiovidone XL-10TNTH/P/WS-034
35Chitro InositolTNTH/P/WS-035
36CelecoxibTNTH/P/WS-036
37Cefixime trydrateTNTH/P/WS-037
38CarbamazepineTNTH/P/WS-038
39CaffeineTNTH/P/WS-039
40Calcium CitrateTNTH/P/WS-040
41CetirizineTNTH/P/WS-041
42Calcium L-5 methyl tetra hydrofolateTNTH/P/WS-042
43Calcium D pantathenateTNTH/P/WS-043
44Cefadamilo monohydrateTNTH/P/WS-044
45Citric AcidTNTH/P/WS-045
46CinnarizineTNTH/P/WS-046
47cyano CobalaminTNTH/P/WS-047
48CephalexineTNTH/P/WS-048
49CetedroxilkTNTH/P/WS-049
50Clopidogrel bisulphateTNTH/P/WS-050
51Calcium citrate maleateTNTH/P/WS-051
52CefiximeTNTH/P/WS-052
53Calcium OxalateTNTH/P/WS-053
54ClonazepamTNTH/P/WS-054
55Cetirizine HCLTNTH/P/WS-055
56CoperamideTNTH/P/WS-056
57CrosporidoneTNTH/P/WS-057
58Colloidal SilicondioxideTNTH/P/WS-058
59CrosporidoneTNTH/P/WS-059
60Dextrose anhydrousTNTH/P/WS-060
61Dextromethor Rhan HBRTNTH/P/WS-061
62DiacerinTNTH/P/WS-062
63Dhenhydramine HCLTNTH/P/WS-063
64DomperidonTNTH/P/WS-064
65DoxycylineTNTH/P/WS-065
66DoxofillineTNTH/P/WS-066
67DutasterideTNTH/P/WS-067
68Dextromethorphan HBRTNTH/P/WS-068
69Dexketoprofen TrometamolTNTH/P/WS-069
70Diethyl Carbamazine CitrateTNTH/P/WS-070
71Dapoxetine HCLTNTH/P/WS-071
72DesvenlafaxineTNTH/P/WS-072
73DeflazocortTNTH/P/WS-073
74Deoxycycline HyclateTNTH/P/WS-074
75Diclofenac SodiumTNTH/P/WS-075
76Dapoxitine HCLTNTH/P/WS-076
77Ethyl CelluloseTNTH/P/WS-077
78EDTA disodiumTNTH/P/WS-078
79EtodolacTNTH/P/WS-079
80Efidronate DisodiumTNTH/P/WS-080
81EmamectinTNTH/P/WS-081
82Esomeprazole MagnesiumTNTH/P/WS-082
83Folic AcidTNTH/P/WS-083
84Flunaxzinedi HClTNTH/P/WS-084
85FurosemideTNTH/P/WS-085
86FlunarizineTNTH/P/WS-086
87Flunarizine HCLTNTH/P/WS-087
88FluconazoleTNTH/P/WS-088
89FenofibrateTNTH/P/WS-089
90Fumed silica AerosilTNTH/P/WS-090
91Fezomine- CTNTH/P/WS-091
92GlimipirideTNTH/P/WS-092
93Glumatic AcidTNTH/P/WS-093
94L- Glutamic AcidTNTH/P/WS-094
95Glucosamine sulfate pottasium chlorideTNTH/P/WS-095
96GliclazideTNTH/P/WS-096
97Hyoscine HydrobromideTNTH/P/WS-097
98Hydroxy propyl celluloseTNTH/P/WS-098
99Hydroxy propyl methyl celluloseTNTH/P/WS-099
100Hydrophilic pyrogenic silicaTNTH/P/WS-100
101Hydro Cortisone AcetateTNTH/P/WS-101
102HypromelloseTNTH/P/WS-102
103Ibandronate SodiumTNTH/P/WS-103
104IbuprofenTNTH/P/WS-104
105IsoniazidTNTH/P/WS-105
106InositolTNTH/P/WS-106
107Ibuprofen SodiumTNTH/P/WS-107
108IguratimodTNTH/P/WS-108
109IrbesartanTNTH/P/WS-109
110Ketotifen Hydrogen fumarateTNTH/P/WS-110
111Ketotifen fumarateTNTH/P/WS-111
112LoperamideTNTH/P/WS-112
113Loperamide HCLTNTH/P/WS-113
114Alpha lipolic acidTNTH/P/WS-114
115LevetriacetamTNTH/P/WS-115
116Levocetixizine HCLTNTH/P/WS-116
117LuliconazoleTNTH/P/WS-117
118L- Lysine mono HClTNTH/P/WS-118
119LorazepamTNTH/P/WS-119
120LacosamideTNTH/P/WS-120
121MatrodextrinTNTH/P/WS-121
122Magnesium stearateTNTH/P/WS-122
123Magnesium HydroxideTNTH/P/WS-123
124MagaldrateTNTH/P/WS-124
125Methyl sulfonic MethaneTNTH/P/WS-125
126MentholTNTH/P/WS-126
127L- MethionineTNTH/P/WS-127
128Meclizine HClTNTH/P/WS-128
129Melatonin 99%TNTH/P/WS-129
1302- Mercapto BenzimidazoleTNTH/P/WS-130
131MupirocinTNTH/P/WS-131
132Methyl CobalamineTNTH/P/WS-132
133L- Methyl folate MagnesiumTNTH/P/WS-133
134Methyl paraban sodiumTNTH/P/WS-134
135Metformin HCLTNTH/P/WS-135
136MyoinositolTNTH/P/WS-136
137Methyl folate calciumTNTH/P/WS-137
138MesalamineTNTH/P/WS-138
139NiacinamideTNTH/P/WS-139
140Nalidixic AcidTNTH/P/WS-140
141NifedipineTNTH/P/WS-141
142OfloxacinTNTH/P/WS-142
143OxetacaineTNTH/P/WS-143
144QuinapyramineTNTH/P/WS-144
145RisperidoneTNTH/P/WS-145
146Ranitidine HCLTNTH/P/WS-146
147Risdronate SodiumTNTH/P/WS-147
148Pancreatin pelletsTNTH/P/WS-148
149ParacetamolTNTH/P/WS-149
150PapainTNTH/P/WS-150
151Pantoprazole sodiumTNTH/P/WS-151
152Phenylephrine HCLTNTH/P/WS-152
153Polyethylene GlycolTNTH/P/WS-153
154L- PhenylalanineTNTH/P/WS-154
155D- PencillamineTNTH/P/WS-155
156Penilloic AcidTNTH/P/WS-156
157PrimidoneTNTH/P/WS-157
158PiperinTNTH/P/WS-158
159Pentoxy fyllineTNTH/P/WS-159
160PyridoxineTNTH/P/WS-160
161Polacrilin pottasiumTNTH/P/WS-161
162PregabalinTNTH/P/WS-162
163PovidoneTNTH/P/WS-163
164Promethazine HCLTNTH/P/WS-164
165Purified TalcTNTH/P/WS-165
166Sodium Lauryl SulphateTNTH/P/WS-166
167Sodium methyl parabenTNTH/P/WS-167
168Sodium Stearyl fumarateTNTH/P/WS-168
169SucralfateTNTH/P/WS-169
170SulfamethaxazoleTNTH/P/WS-170
171Solicin- 10 (Blend)TNTH/P/WS-171
172Saccharin SodiumTNTH/P/WS-172
173Salbutamol SO4TNTH/P/WS-173
174Saw pallmette ExtractTNTH/P/WS-174
175Sodium BromideTNTH/P/WS-175
176Serratie peptidaseTNTH/P/WS-176
177Sevelamer peptidaseTNTH/P/WS-177
178Sevelamer carbonateTNTH/P/WS-178
179Sinopol peg- 4000 powderTNTH/P/WS-179
180Sodium bicarbonateTNTH/P/WS-180
181Sodium benzoateTNTH/P/WS-181
182Sodium carbonateTNTH/P/WS-182
183Sodium feriedetatTNTH/P/WS-183
184SucralfateTNTH/P/WS-184
185TadalafilTNTH/P/WS-185
186TinidazoleTNTH/P/WS-186
187Tamsulosin HCLTNTH/P/WS-187
188ThiocolchicorideTNTH/P/WS-188
189L- TyrosineTNTH/P/WS-189
190TrimethoprimTNTH/P/WS-190
191Tranexamic AcidTNTH/P/WS-191
192Tramadol HCLTNTH/P/WS-192
193TramadolTNTH/P/WS-193
194TopamedTNTH/P/WS-194
195Titanium dioxideTNTH/P/WS-195
196Vitamin K2-7 1000 PPMTNTH/P/WS-196
197VogliboseTNTH/P/WS-197
198L- Valine Methyl esterTNTH/P/WS-198
199Warfarine Sodium clathrateTNTH/P/WS-199
200MenadioneTNTH/P/WS-200
201Gentamycin sulphateTNTH/P/WS-201
202Neomycin sulphateTNTH/P/WS-202
203RiboflavinTNTH/P/WS-203
204Riboflavin 5 phosphateTNTH/P/WS-204
205MenaquinoneTNTH/P/WS-205
206Thiamine HCLTNTH/P/WS-206
207Alpha tocopherol AcetateTNTH/P/WS-207
208Vitamin A retinol AcetateTNTH/P/WS-208
209Nicotinic AcidTNTH/P/WS-209
210Pyridoxine HCLTNTH/P/WS-210
211D- PanthenolTNTH/P/WS-211
212Methyl CobalamideTNTH/P/WS-212
213Vitamin C CoatedTNTH/P/WS-213
214CholecalciferolTNTH/P/WS-214
215Serotonine HCLTNTH/P/WS-215
216Vincristine SulphateTNTH/P/WS-216
217MetronidazoleTNTH/P/WS-217
218Gallic AcidTNTH/P/WS-218
219D- BiotinTNTH/P/WS-219
220AjmalicineTNTH/P/WS-220
221MethopreneTNTH/P/WS-221
222Ascorbic Acid PlainTNTH/P/WS-222
223Sodium Starch GlycolateTNTH/P/WS-223
224Sodium CitrateTNTH/P/WS-224
225AcetaminophenTNTH/P/WS-225
226Sodium BromideTNTH/P/WS-226
227FlunarazineTNTH/P/WS-227