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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
Imatinib Impurity 7 Imatinib Impurity 7 581076-64-4 C8H12N4
Nilotinib Impurity 1 Nilotinib Impurity 1 641571-05-3 C28H22F3N7O
Riociguat Impurtiy 1 Riociguat Impurtiy 1
Riociguat Impurtiy 6 Riociguat Impurtiy 6 1702271-98-4 C18H17FN8
Axitinib Impurity 4 Axitinib Impurity 4 1443118-73-7 C22H20N4OS
Brimonidine Impurity E Brimonidine Impurity E 168329-48-4 C9H8BrN5
Dapagliflozin Impurity G Dapagliflozin Impurity G
Dapoxetine Impurity B Dapoxetine Impurity B
Esomeprazole EP Impurity Esomeprazole EP Impurity
Fesoterodine Diol Dimer Fesoterodine Diol Dimer 1428856-45-4 C44H60N2O3
Gimeracil Impurity Gimeracil Impurity 17902-24-8 C8H9ClN2O3
Pramipexole Impurity H Pramipexole Impurity H
Quercetin 3-rutinoside 7-glucoside Quercetin 3-rutinoside 7-glucoside 30311-61-6 C33H40O21
Rivaroxaban Impurity H Rivaroxaban Impurity H 1807455-76-0 C25H24Cl2N4O6S2
Vonoprazan impurity A Vonoprazan impurity A
3-Cyano-4-isobutoxybenzoic acid 3-Cyano-4-isobutoxybenzoic acid 528607-60-5 C12H13NO3
5-Chloro-N1-Methylbenzene-1,2-diaMine 5-Chloro-N1-Methylbenzene-1,2-diaMine 84859-27-8 C7H9ClN2
(1'S,3'S,4'S)-Entecavir IsoMer (1'S,3'S,4'S)-Entecavir IsoMer 1367369-80-9 C12H15N5O3
REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane 139757-68-9 C8H11N3O3S
(S)-N-Didemethyl Dapoxetine (S)-N-Didemethyl Dapoxetine 147199-40-4 C19H19NO
Hydroxy Flunarizine Hydroxy Flunarizine 87166-81-2 C26H26F2N2O
1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 139756-00-6 C8H11N3O4
6-Hydroxy Nicorandil 6-Hydroxy Nicorandil 113743-17-2 C8H9N3O5
trans-Itraconazole trans-Itraconazole 252964-65-1 C35H38Cl2N8O4
N-(2-Pyridyl)oxamic Acid N-(2-Pyridyl)oxamic Acid 13120-39-3 C7H6N2O3
Iso Ganciclovir Iso Ganciclovir 86357-09-7 C9H13N5O4
(1S,3R)-1-Benzo[1,3]dioxol-5-yl-2-(2-chloro-acetyl)-2,3,4,9-tetrahydro-1H-b-carboline-3-carboxylic Acid Methyl Ester (1S,3R)-1-Benzo[1,3]dioxol-5-yl-2-(2-chloro-acetyl)-2,3,4,9-tetrahydro-1H-b-carboline-3-carboxylic Acid Methyl Ester 629652-40-0 C22H19ClN2O5
2-Butyl-1,6-dihydro-N,N,4-trimethyl-6-oxo-1-[[2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1'-biphenyl]-4-yl]methyl]-5-pyrimidineacetamide 2-Butyl-1,6-dihydro-N,N,4-trimethyl-6-oxo-1-[[2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1'-biphenyl]-4-yl]methyl]-5-pyrimidineacetamide 503155-67-7 C46H45N7O2
O-De(3-fluorobenzyl) Lapatinib O-De(3-fluorobenzyl) Lapatinib 1268997-70-1 C22H21ClN4O4S
5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethylenediol 5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethylenediol 112935-92-9 C14H20N2O6
Desloratadine Epoxide Desloratadine Epoxide 1346604-23-6 C19H19ClN2O
Menaquinone 4 2,3-Epoxide Menaquinone 4 2,3-Epoxide 72908-86-2 C31H40O3
D-Phenylalanyl Nateglinide D-Phenylalanyl Nateglinide 944746-48-9 C28H36N2O4
Felodipine 3,5-DiMethyl Ester Felodipine 3,5-DiMethyl Ester 91189-59-2 C17H17Cl2NO4
1-BENZYL-N,4-DIMETHYLPIPERIDIN-3-AMINE DIHYDROCHLORIDE 1-BENZYL-N,4-DIMETHYLPIPERIDIN-3-AMINE DIHYDROCHLORIDE 384338-23-2 C14H22N2
(R,Z)-2-((R)-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)(carboxy)Methyl)-5-ethylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (R,Z)-2-((R)-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)(carboxy)Methyl)-5-ethylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid 178422-39-4 C14H15N5O6S2
Acyclovir IMpurity C Acyclovir IMpurity C 91702-61-3 C8H11N5O3
Nicergoline-5-Chloro Analogue Nicergoline-5-Chloro Analogue 38536-28-6 C24H26ClN3O3
1-(3-aMino-5-(benzyloxy)-2-hydroxyphenyl)ethanone 1-(3-aMino-5-(benzyloxy)-2-hydroxyphenyl)ethanone 861841-90-9 C15H15NO3
(2RS)-2-Hydroxy-2-[4-(2-Methylpropyl)phenyl]propanoic Acid (2RS)-2-Hydroxy-2-[4-(2-Methylpropyl)phenyl]propanoic Acid C13H18O3
(3RS)-1,3-Bis[4-(2-Methylpropyl) phenyl]butan-1-one (3RS)-1,3-Bis[4-(2-Methylpropyl) phenyl]butan-1-one C24H32O
2-[4-(2-Methylpropyl)phenyl] ethanol 2-[4-(2-Methylpropyl)phenyl] ethanol 2143535-25-3 C24H32O
1-cyclopropyl-6-fluoro-8-hydroxy-4-oxo-7-((4aR,7aR)-tetrahydro-1H-pyrrolo[3,4-b]pyridin-6(2H,7H,7aH)-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrobroMide 1-cyclopropyl-6-fluoro-8-hydroxy-4-oxo-7-((4aR,7aR)-tetrahydro-1H-pyrrolo[3,4-b]pyridin-6(2H,7H,7aH)-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrobroMide 1292904-74-5 C20H23BrFN3O4
IMp. B (EP) IMp. B (EP)
IMp. K (EP) IMp. K (EP) 40610-41-1 C13H17NO3
(Z)-Methyl 3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylate (Z)-Methyl 3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylate 1499167-72-4 C23H20N4O4
4-(4-fluorobenzoyl)-3-(hydroxyMethyl)benzonitrile 4-(4-fluorobenzoyl)-3-(hydroxyMethyl)benzonitrile 260371-16-2 C15H10FNO2
ATV-FX1 sodiuM salt ATV-FX1 sodiuM salt 1315629-79-8 C33H34FN2NaO7
Montelukast Impurity H Montelukast Impurity H 851755-56-1 C34H32ClNO4S
SalMeterol EP IMpurity F SalMeterol EP IMpurity F 1391054-40-2 C25H37NO3
[6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-7-yl] [6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-7-yl] 1391054-73-1 C28H27NO4S
(R)-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]Methyl]-1-naphthaleneMethaneaMine Hydrochloride (R)-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]Methyl]-1-naphthaleneMethaneaMine Hydrochloride 1229225-42-6 C20H19ClF3N
3(S)-Hydroperoxy Simvastatin 3(S)-Hydroperoxy Simvastatin 1092716-44-3 C25H38O7
2(RS)-4-Methyl-1-(3-Methylpyridin-2-yl)-2-phenylpiperazine 2(RS)-4-Methyl-1-(3-Methylpyridin-2-yl)-2-phenylpiperazine 191546-94-8 C17H21N3
(trans)-4-Propyl-1-methyl-L-proline (trans)-4-Propyl-1-methyl-L-proline 13380-36-4 C9H17NO2
N-Nordextromethorphan
N-Nordextromethorphan 1531-23-3 C17H23NO
(S,S,R,R)-Orlistat (S,S,R,R)-Orlistat 111466-62-7 C29H53NO5
17β-Carboxy-17-desoxy Dexamethasone 17β-Carboxy-17-desoxy Dexamethasone 75262-69-0 C21H27FO4
1-(dimethoxymethyl)-3-methoxybenzene 1-(dimethoxymethyl)-3-methoxybenzene 59276-28-7 C10H14O3
Benazepril impurity A Benazepril impurity A C24H28N2O5
3S,4R-4-[phenyl-1-methylpiperidinyl] methanol 3S,4R-4-[phenyl-1-methylpiperidinyl] methanol 176022-03-0 C13H19NO
Allopurinol Related CoMpound F Allopurinol Related CoMpound F 321571-07-7 C12H14N4O4
N-[(n-butylaMino)carbonyl]-4-[(3-Methylphenyl)aMino]-3-pyridinesulfonaMide N-[(n-butylaMino)carbonyl]-4-[(3-Methylphenyl)aMino]-3-pyridinesulfonaMide 160972-33-8 C17H22N4O3S
(R)-N-DeMethyl Dapoxetine (R)-N-DeMethyl Dapoxetine 1202160-36-8 C20H21NO
14,15-Dehydro Budesonide 14,15-Dehydro Budesonide 131918-64-4 C25H32O6
2-(BenzylMethylaMino)-3',4'-dihydroxyacetophenone 2-(BenzylMethylaMino)-3',4'-dihydroxyacetophenone 36467-25-1 C16H17NO3
2'-O-(5'-Deoxy-β-D-ribofuranosyl) Capecitabine 2'-O-(5'-Deoxy-β-D-ribofuranosyl) Capecitabine 1262133-66-3 C20H30FN3O9
4-Defluoro-4-hydroxy Gefitinib 4-Defluoro-4-hydroxy Gefitinib 847949-50-2 C22H25ClN4O4
Desethyl Sildenafil Desethyl Sildenafil 139755-91-2 C20H26N6O4S
N-Desisopropyl-N-forMyl Bisoprolol N-Desisopropyl-N-forMyl Bisoprolol 1346602-59-2 C16H25NO5
N-DesMethyl Olopatadine N-DesMethyl Olopatadine 113835-92-0 C20H21NO3
10-Keto DextroMethorphan 10-Keto DextroMethorphan 57969-05-8 C18H23NO2
2'-[(1H-Tetrazol-5-yl)biphenyl-4-yl]Methanol 2'-[(1H-Tetrazol-5-yl)biphenyl-4-yl]Methanol 160514-13-6 C14H12N4O
3''-HABA KanaMycin A 3''-HABA KanaMycin A 50725-25-2 C22H43N5O13
ent-Paroxol ent-Paroxol 389573-45-9 C13H18FNO
Ethyl α-Thioglucopyranoside Ethyl α-Thioglucopyranoside 13533-58-9 C8H16O5S
Febuxostat Acyl-β-D-glucuronide Febuxostat Acyl-β-D-glucuronide 1351692-92-6 C22H24N2O9S
Keto Bisoprolol Keto Bisoprolol 864544-37-6 C18H29NO5
Olopatadine Carbaldehyde  DISCONTINUED Olopatadine Carbaldehyde DISCONTINUED 1376615-97-2 C21H23NO2
5-Chloro-1-methyl-4-nitroimidazole 5-Chloro-1-methyl-4-nitroimidazole C4H4ClN3O2
Nisoldipine Related Compound  II Nisoldipine Related Compound II
AgoMelatine DiMer Urea AgoMelatine DiMer Urea 185421-27-6 C27H28N2O3
AgoMelatine DiMer Urea AgoMelatine DiMer Urea 185421-27-6 C27H28N2O3
Isotachysterol3 Isotachysterol3 22350-43-2 C27H44O
Nitrendipine Propyl Ester Nitrendipine Propyl Ester 225785-54-6 C19H22N2O6
O-DesMethyl Urapidil O-DesMethyl Urapidil 91453-03-1 C19H27N5O3
(1R,3R,4R)-Entecavir (1R,3R,4R)-Entecavir 1367369-76-3 C12H15N5O3
5-(5-chloro-1-(2-fluorophenyl)-2-oxopentyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 5-(5-chloro-1-(2-fluorophenyl)-2-oxopentyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 1056459-37-0 C20H21ClFNO3S
(2S,3R)-2-((S)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-3-(4-fluorophenyl)Morpholine (2S,3R)-2-((S)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-3-(4-fluorophenyl)Morpholine 327623-37-0 C20H18F7NO2
Linagliptin iMpurity Linagliptin iMpurity 2140263-92-7 C25H28N8O2
1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxaMide 1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxaMide 256376-62-2 C14H11FN4O
Alogliptin iMpurity Alogliptin iMpurity 60271-06-9 C7H10N2O3
Alogliptin iMpurity Alogliptin iMpurity 60271-06-9 C7H10N2O3
cefaclor iMpurity H cefaclor iMpurity H C4H6N4O3S2
Tadalafil iMpurity E Tadalafil iMpurity E
3,3',5-TRIIODOTHYROPROPIONIC ACID 3,3',5-TRIIODOTHYROPROPIONIC ACID 51-26-3 C15H11I3O4
Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) 863329-64-0 C31H27N3O8
(R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile 1268836-55-0 C31H30N8O4
(R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile 1268836-55-0 C31H30N8O4
1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1415908-67-6 C13H20N2O4S
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