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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
Peramivir Impurity 9 Peramivir Impurity 9
PidotimodImpurity T PidotimodImpurity T
(2R,4S)-4-([1,1'-Biphenyl]-4-ylmethyl)-2-methyl-4-(2,5-dioxopyrrolidin-1-yl)butanoic acid (2R,4S)-4-([1,1'-Biphenyl]-4-ylmethyl)-2-methyl-4-(2,5-dioxopyrrolidin-1-yl)butanoic acid 1639970-62-9 C22H23NO4
Nicorandil Impurity 1 Nicorandil Impurity 1
Piperacillin Impurity 6 Piperacillin Impurity 6
Bosutinib Impurity 5 Bosutinib Impurity 5 1391063-17-4 C26H29Cl2N5O3
Afatinib Impurity 14 Afatinib Impurity 14
N-(3-chloro-4-fluorophenyl)-6 ,7-dimethoxyquinazolin-4-amine N-(3-chloro-4-fluorophenyl)-6 ,7-dimethoxyquinazolin-4-amine 153437-78-6 C16H13ClFN3O2
Itopride Impurity C Itopride Impurity C 141996-97-6 C19H24N2O4
Mirabegron Impurity Mirabegron Impurity 1796931-48-0 C21H24N4O2S
4'-FLUOROCYCLOPROPANECARBOXANILIDE 4'-FLUOROCYCLOPROPANECARBOXANILIDE 2354-89-4 C10H10FNO
2-Diethylamino-N-(2,5-dimethyl-phenyl)-acetamide 2-Diethylamino-N-(2,5-dimethyl-phenyl)-acetamide 857570-37-7 C14H22N2O
(R)-1-BENZYL-3-N-BOC-AMINOPIPERIDINE (R)-1-BENZYL-3-N-BOC-AMINOPIPERIDINE 216854-24-9 C17H26N2O2
ethyl 4-dimethylamino-3-hydroxy-butanoate ethyl 4-dimethylamino-3-hydroxy-butanoate 90227-57-9 C8H17NO3
ethyl 4-dimethylamino-3-hydroxy-butanoate ethyl 4-dimethylamino-3-hydroxy-butanoate 90227-57-9 C8H17NO3
2(1H)-Pyridinone, 3,4-dihydro- 2(1H)-Pyridinone, 3,4-dihydro- 57147-25-8 C5H7NO
TRANS-ZEATIN GLUCOSIDE TRANS-ZEATIN GLUCOSIDE 56329-06-7 C16H23N5O6
Ibrutinib Impurity 9 Ibrutinib Impurity 9 2068022-09-1 C25H21D5N6O4
methyl(E)-4-(methylamino)but-2-enoate methyl(E)-4-(methylamino)but-2-enoate 915788-22-6 C6H11NO2
methyl(E)-4-(methylamino)but-2-enoate methyl(E)-4-(methylamino)but-2-enoate 915788-22-6 C6H11NO2
Levomilnacipran  impurity Levomilnacipran impurity
Sofosbuvir IMpurity 4 Sofosbuvir IMpurity 4
1,3-bis(4-isobutylphenyl)butan-1-one 1,3-bis(4-isobutylphenyl)butan-1-one C24H32O
6-isobutyl-3-methyl-2,3-dihydro-1H-inden-1-one 6-isobutyl-3-methyl-2,3-dihydro-1H-inden-1-one 1340024-54-5 C14H18O
Edoxaban impurity 1 Edoxaban impurity 1 41374-72-5 C9H10N2O3
Canagliflozin Impurity 18 Canagliflozin Impurity 18
Canagliflozin Impurity 23 Canagliflozin Impurity 23
Carfilzomib Impurity 4 Carfilzomib Impurity 4
Lenvatinib Impurity 2 Lenvatinib Impurity 2 2380197-90-8 C28H22ClN5O5
FeBuxostat Impurity 33 FeBuxostat Impurity 33 100118-38-5 C12H14O5
(S)-3-(4-phenoxyphenyl)-1-(piperidin-3-yl) (S)-3-(4-phenoxyphenyl)-1-(piperidin-3-yl) 1642630-12-3 C22H22N6O
Latamoxef Impurity 1 Latamoxef Impurity 1 75007-70-4 C19H20N6O7S
Amlodipine iMpurity K Amlodipine iMpurity K 1809326-44-0 C18H21ClN2O5
Cabozantinib impurity 4 Cabozantinib impurity 4 95932-39-1 C11H15NO3
Rosuvastatin EP Impurity C Rosuvastatin EP Impurity C 1620823-61-1 C22H27FN3NaO6S
6,7-bis(2-methoxyethoxy)-N-phenylquinazolin-4-amine 6,7-bis(2-methoxyethoxy)-N-phenylquinazolin-4-amine 1145671-52-8 C20H23N3O4
(3R,4R,5S)-ethyl 4-acetamido-5-amino-3-isopropoxycyclohex-1-enecarboxylate (3R,4R,5S)-ethyl 4-acetamido-5-amino-3-isopropoxycyclohex-1-enecarboxylate 1052063-36-1 C14H24N2O4
4-(N-(tert-butyl)acetamido)-5-(diallylamino)-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate 4-(N-(tert-butyl)acetamido)-5-(diallylamino)-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate 941296-96-4 C16H28N2O4
(2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylic acid (2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylic acid C8H8FN3O4S
Amlodipine Impurity 10 Amlodipine Impurity 10 2170104-51-3 C26H31ClN2O8S
Apixaban Impurity 15 Apixaban Impurity 15 1466571-07-2 C21H20N4O4
Clopidogrel Impurity 8 Clopidogrel Impurity 8 C15H14ClNO2S
Acyclovir Impurity I: 7,9'-[Ethylene-bis(oxymethylene)] Bis (2-amino-1-9-dihydro-6H-purin-6-one) Acyclovir Impurity I: 7,9'-[Ethylene-bis(oxymethylene)] Bis (2-amino-1-9-dihydro-6H-purin-6-one) 1797832-75-7 C14H16N10O4
Nilotinib genotoxic impurity 3 Nilotinib genotoxic impurity 3 915711-42-1 C19H17F3N4O
Dapagliflozin Open Ring Dapagliflozin Open Ring 2100872-88-4 C21H27ClO7
Rortezide impurity Rortezide impurity
4-CHLORO-3-HYDROXY BUTYRONITRILE 4-CHLORO-3-HYDROXY BUTYRONITRILE 105-33-9 C4H6ClNO
(Z)-2-propylhept-2-enal (Z)-2-propylhept-2-enal 95667-14-4 C10H18O
(R)-3-AMINO-4-(2,4-DIFLUOROPHENYL)-BUTYRIC ACID-HCL (R)-3-AMINO-4-(2,4-DIFLUOROPHENYL)-BUTYRIC ACID-HCL 1335470-16-0 C10H11F2NO2
(R)-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile (R)-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile C23H25N7O4
(R)-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile (R)-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile C23H25N7O4
4,4'-dichloro-3,3'-bis(4-ethoxybenzyl)-1,1'-biphenyl 4,4'-dichloro-3,3'-bis(4-ethoxybenzyl)-1,1'-biphenyl 2176485-21-3 C30H28Cl2O2
N-(2,6-dimethylphenyl)-2-((2,6-dimethylphenyl)amino)acetamide N-(2,6-dimethylphenyl)-2-((2,6-dimethylphenyl)amino)acetamide 294852-91-8 C18H22N2O
N6-propyl-3a,4,5,6,7,7a-hexahydrobenzo[d]thiazole-2,6-diamine N6-propyl-3a,4,5,6,7,7a-hexahydrobenzo[d]thiazole-2,6-diamine 1052691-22-1 C10H19N3S
Aprepitant Impurity 2 Aprepitant Impurity 2
Cabozantinib Impurity A Cabozantinib Impurity A
Loxoprofen Impurity E Loxoprofen Impurity E
(R)-4-Propylpyrrolidin-2-one (R)-4-Propylpyrrolidin-2-one 930123-37-8 C7H13NO
Rocuronium Bromide Intermediate B Impurity E-1 Rocuronium Bromide Intermediate B Impurity E-1 1190105-60-2 C29H48N2O3
4-Chloro-2-propylsulfanyl-pyrimidine 4-Chloro-2-propylsulfanyl-pyrimidine 1351990-36-7 C7H9ClN2S
benzyl (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoate benzyl (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoate 1194550-67-8 C36H30Cl2N2O7S
D-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]- D-Proline, 1-[(2S)-3-mercapto-2-methyl-1-oxopropyl]- 119238-52-7 C9H15NO3S
2,4(1H,3H)-Pyrimidinedione,5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, (2S-cis)- (9CI) 2,4(1H,3H)-Pyrimidinedione,5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, (2S-cis)- (9CI) 145281-92-1 C8H9FN2O4S
Cyclopentanecarboxylic acid, 1-[(1-oxopentyl)amino]- Cyclopentanecarboxylic acid, 1-[(1-oxopentyl)amino]- 15026-80-9 C11H19NO3
L-Phenylalanine, N-L-leucyl-, methyl ester L-Phenylalanine, N-L-leucyl-, methyl ester 38155-18-9 C16H24N2O3
Ethanol, 2-[(2-chloroethyl)amino]- Ethanol, 2-[(2-chloroethyl)amino]- 3890-98-0 C4H10ClNO
5-Methylarabinosylcytosine 5-Methylarabinosylcytosine 6829-31-8 C10H15N3O5
Anthranilic acid, N-furfuryl-5-sulfamoyl- Anthranilic acid, N-furfuryl-5-sulfamoyl- 4818-85-3 C12H12N2O5S
1,3-Benzodioxol-4-ol 1,3-Benzodioxol-4-ol 69393-72-2 C7H6O3
1H-Benzimidazole, 6-bromo-2-methyl-4-(phenylmethoxy)- 1H-Benzimidazole, 6-bromo-2-methyl-4-(phenylmethoxy)- 774582-60-4 C15H13BrN2O
(E)-N-(2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethyl)acetamide (E)-N-(2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethyl)acetamide 178677-39-9 C15H19NO2
(E)-N-(2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethyl)acetamide (E)-N-(2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethyl)acetamide 178677-39-9 C15H19NO2
(Z)-methyl 3-(((4-(methylamino)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate (Z)-methyl 3-(((4-(methylamino)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate 1987887-92-2 C24H21N3O3
1-(prop-1-en-2-yl)-3-(2-(4-(3-(trifluoromethyl)phenyl)piperazin-1-yl)ethyl)-1H-benzo[d]imidazol-2(3H)-one 1-(prop-1-en-2-yl)-3-(2-(4-(3-(trifluoromethyl)phenyl)piperazin-1-yl)ethyl)-1H-benzo[d]imidazol-2(3H)-one 1971858-36-2 C23H25F3N4O
2-(3-(methylamino)-1-(thiophen-2-yl)propyl)naphthalen-1-ol 2-(3-(methylamino)-1-(thiophen-2-yl)propyl)naphthalen-1-ol 1033803-59-6 C18H19NOS
Bendamustine Desmethyl Impurity Bendamustine Desmethyl Impurity 41515-13-3 C15H19Cl2N3O2
(R)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine (R)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine 878757-08-5 C19H21NOS
Apixaban Impurity 17 Apixaban Impurity 17 2204368-51-2 C29H31N5O5
Aprepitant Impurity 24 Aprepitant Impurity 24
Aripiprazole Impurity 11 Aripiprazole Impurity 11
Aripiprazole Impurity 11 Aripiprazole Impurity 11
Avanafil Impurity 10 Avanafil Impurity 10
Capecitabine Impurity 10 Capecitabine Impurity 10
Carfilzomib Impurity C Carfilzomib Impurity C
Cefathiamidine Impurity 4 Cefathiamidine Impurity 4 1418224-75-5 C10H11BrN2O5S
Cefodizime Impurity 2 Cefodizime Impurity 2
Choline Fenofibrate Impurity 1 Choline Fenofibrate Impurity 1 2985-79-7 C13H9ClO2
DecitaBine Impurity 11 DecitaBine Impurity 11
Isavuconazole Impurity 21 Isavuconazole Impurity 21
Isavuconazole Impurity 27 Isavuconazole Impurity 27
Istradefylline Impurity E Istradefylline Impurity E
Linagliptin Impurity 41 Linagliptin Impurity 41
PalBociclib Impurity 17 PalBociclib Impurity 17
PalBociclib Impurity 24 PalBociclib Impurity 24
Posaconazole Impurity 12 Posaconazole Impurity 12
Posaconazole Impurity 24 Posaconazole Impurity 24 165115-78-6 C19H20F2O2
Sitagliptin Impurity 24 Sitagliptin Impurity 24 2349567-54-8 C15H19F2NO4
Tamoxifen EP Impurity H Tamoxifen EP Impurity H 809285-09-4 C43H48N2O2
Tenofovir impurity Q Tenofovir impurity Q
Trelagliptin Impurity 20 Trelagliptin Impurity 20 1821520-42-6 C20H22FN5O3
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