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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Aripiprazole EP impurity D Aripiprazole EP impurity D
Macitentan impurity B Macitentan impurity B 441796-13-0 C18H18Br2N6O4S
Meropenem IMP B Meropenem IMP B
tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate 412348-27-7 C14H20BrN3O2
1-((2R,3R)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one 1-((2R,3R)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one 2243786-01-6 C30H35N5O3
5-(3-fluorophenyl)-1H-pyrrole-3-carbaldehyde 5-(3-fluorophenyl)-1H-pyrrole-3-carbaldehyde C11H8FNO
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid bis(1-methylethyl) ester 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid bis(1-methylethyl) ester 21881-78-7 C21H26N2O6
2-(4-Methylphenyl)sulfonyloxyethanol 2-(4-Methylphenyl)sulfonyloxyethanol 42772-85-0 C9H12O4S
2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 1564265-94-6 C18H25N3O2
(S)-N-(1-(3-MethylbutanaMido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide (S)-N-(1-(3-MethylbutanaMido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide 862894-96-0 C19H22N4O3
Ticagrelor iMpurity Ticagrelor iMpurity 1882095-51-3 C27H45N5O8S
cefaclor iMpurity G cefaclor iMpurity G 67308-21-8 C16H17N3O4S
Rupatadine iMpurity E Rupatadine iMpurity E
Tadalafil iMpurity D Tadalafil iMpurity D 951661-81-7 C22H20ClN3O4
EMpagliflozin  iMpurity 8 EMpagliflozin iMpurity 8
EMpagliflozin  iMpurity 13 EMpagliflozin iMpurity 13 2125472-55-9 C23H25ClO8
6-Methyldi(ondansetron-3-de(1,2-diMethyl-1H-iMidazole)) 6-Methyldi(ondansetron-3-de(1,2-diMethyl-1H-iMidazole)) 1365727-07-6 C27H26N2O2
(2R,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid (2R,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid 1012341-56-8 C23H29NO4
Alogliptin Impurity A Alogliptin Impurity A
Linagliptin Impurity D Linagliptin Impurity D 666816-91-7 C20H28N6O4
Parecoxib Impurity C Parecoxib Impurity C 3026677-40-4
Rac Atomoxetine Hydrochloride Rac Atomoxetine Hydrochloride 82857-40-7 C17H22ClNO
3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline 3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline 943320-48-7 C10H8F3N3
Linagliptin Impurity H Linagliptin Impurity H 1646355-34-1 C22H23N7O2
Ezetimibe Impurity 54 Ezetimibe Impurity 54 1185883-39-9 C40H36F2N2O5
2-(2-fluorophenyl)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol 2-(2-fluorophenyl)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol 1348664-75-4 C13H13FN6O
Dapagliflozin Impurity 2 Dapagliflozin Impurity 2
Imatinib Impurity 1 Imatinib Impurity 1
Imatinib Impurity 6 Imatinib Impurity 6
Nifedipine Impurity 3 Nifedipine Impurity 3 C19H22N2O6
Riociguat Impurtiy 5 Riociguat Impurtiy 5
Vonoprazan Impurity 6 Vonoprazan Impurity 6
Avibactam Impurity Avibactam Impurity 1797133-98-2 C7H11N3O6S.Na
Citalopram EP Impurity E Citalopram EP Impurity E 64169-47-7 C19H22Cl2FNO
Dapagliflozin Impurity F Dapagliflozin Impurity F
Dapoxetine Impurity A Dapoxetine Impurity A
Entecavir  Impurity Entecavir Impurity 1333204-94-6 C12H15N5O3
Gadobutrol Impurity Gadobutrol Impurity 71231-87-3 C7H15NO5
Lesinurad Impurity Lesinurad Impurity
Pramipexole Impurity G Pramipexole Impurity G
Salmeterol EP Impurity A Salmeterol EP Impurity A 1798014-51-3 C19H25NO3
Tacrolimus impurity D Tacrolimus impurity D
2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4,4-dimethyl-4,5-dihydrooxazole 2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4,4-dimethyl-4,5-dihydrooxazole 202189-77-3 C32H44N4O2
Saxagliptin Impurity 6 Saxagliptin Impurity 6
Alcaftadine N-Oxide Alcaftadine N-Oxide 952649-75-1 C19H21N3O2
Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate 202534-94-9 C15H16FNO4
Tofacitinib Impurity H Tofacitinib Impurity H
3',6'-Dehydroclindamycin 3',6'-Dehydroclindamycin 1440605-51-5 C18H31ClN2O5S
Iguratimod Impurity 5 Iguratimod Impurity 5 84594-95-6 C13H11NO4
Cefradine Impurity F Cefradine Impurity F
Mirabegron Impurity Mirabegron Impurity 1684452-83-2 C26H28N6O3S2
1-methyl-1H-indol-6-ol 1-methyl-1H-indol-6-ol 130570-60-4 C9H9NO
2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 118485-48-6 C13H13NO3S
FLUORIDE STANDARD FLUORIDE STANDARD 16984-48-8 F-
32-Carboxycyanocobalamin 32-Carboxycyanocobalamin 121483-62-3 C63H87CoN13O15P
Alvimopan Impurity 6 Alvimopan Impurity 6
Acarbose Impurity B Acarbose Impurity B
Sofosbuvir Impurity28 Sofosbuvir Impurity28
Rivaroxaban Impurity 10 Rivaroxaban Impurity 10
Ipragliflozin Impurity 1 Ipragliflozin Impurity 1
(17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile (17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile 98149-13-4 C20H24BrNO2
316173-27-0 316173-27-0 316173-27-0 C17H28N2O5
Azilsartan Impurity Azilsartan Impurity 1821386-21-3 C22H18N4O4
Irbesartan Impurity 7 Irbesartan Impurity 7 C25H28N6O
Voriconazole Impurity 2 Voriconazole Impurity 2
Safinamide Impurity 1 Safinamide Impurity 1
Caspofungin impurit 2 Caspofungin impurit 2
Lamivudine impurity 1 Lamivudine impurity 1
Raltitrexed Impurity 1 Raltitrexed Impurity 1 1378372-01-0 C10H10N2O2
Loratadine Impurity 6 Loratadine Impurity 6 C22H23ClN2O2
Mirabegron Impurity 3 Mirabegron Impurity 3
Plerixafor Impurity C Plerixafor Impurity C
Vonoprazan Impuirty 8 Vonoprazan Impuirty 8
Sitagliptin IMpurity 4 Sitagliptin IMpurity 4
Brexpiprazole Impurity1 Brexpiprazole Impurity1
Acarbose Impurity E Acarbose Impurity E
Alvimopan Impurity 1 Alvimopan Impurity 1 2250243-53-7 C14H19NO
Febuxostat Impurity A Febuxostat Impurity A
Fingolimod Hexyl Impurity Fingolimod Hexyl Impurity 1201794-93-5 C17H29NO2
Palbociclib Impurity 1 Palbociclib Impurity 1
Trelagliptin Impurity 8 Trelagliptin Impurity 8
Bromhexine Impurity H Bromhexine Impurity H 63471-27-2 C14H21BrN2
Apixaban Impurity 17 Apixaban Impurity 17 1423803-24-0 C20H19N5O3
Rivaroxaban Impurity 11 Rivaroxaban Impurity 11 1411775-06-8 C14H17N3O4
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate C25H35NO3
Flomoxef Impurity 4 Flomoxef Impurity 4
Nicardipine Impurity 5 Nicardipine Impurity 5
11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 263366-81-0 C30H24Cl2N6
Sacubitril Impurity 7 Sacubitril Impurity 7 149709-44-4 C22H25NO5
Valsartan Impurity 5 Valsartan Impurity 5 1266616-11-8 C18H21N5
3-Hydroxy Agomelatine 3-Hydroxy Agomelatine 166526-99-4 C15H17NO3
Milnacipran Impurity 4 Milnacipran Impurity 4 1353644-49-1 C15H21NO2
(3S,5R)-Atorvastatin (3S,5R)-Atorvastatin 887324-52-9 C33H35FN2O5
Heptyl Deoctyl Fingolimod Hydrochloride Heptyl Deoctyl Fingolimod Hydrochloride 745767-97-9 C18H31NO2
Tenofovir Fumarate Tenofovir Fumarate 1246812-23-6 C21H34N5O9P
Engleet net impurity 07 Engleet net impurity 07 1620758-33-9 C23H27ClO7
Prucalopride Impurity C Prucalopride Impurity C 1599434-55-5 C17H24ClN3O3
1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 2205053-60-5 C21H24FN3O4
Brexpiprazole N-Oxide Brexpiprazole N-Oxide 1191900-58-9 C25H27N3O3S
2,6-Dibenzyloxyacetophenone 2,6-Dibenzyloxyacetophenone 3886-19-9 C22H20O3
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