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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
Fasudil iMpurity E Fasudil iMpurity E
Tigecycline Impurity 6 Tigecycline Impurity 6
Febuxostat Bromo Impurity Febuxostat Bromo Impurity 144060-40-2 C15H16BrNO3S
Meptazinol Impurity Meptazinol Impurity 1314003-47-8 C23H28N2O4
1'H-2,3'-bipyridinyl-2'-one 1'H-2,3'-bipyridinyl-2'-one 101002-01-1 C10H8N2O
Brexpiprazole Impurity D Brexpiprazole Impurity D
Brivaracetam Impurity E Brivaracetam Impurity E
Dapoxetine Impurity 8 Dapoxetine Impurity 8
Irbesartan Impurity 6 Irbesartan Impurity 6 C25H28N6O
Empagliflozin impurity B Empagliflozin impurity B
Varenicline Impurity 1 Varenicline Impurity 1
Voriconazole Impurity 6 Voriconazole Impurity 6
Caspofungin impurity 1 Caspofungin impurity 1
Cabozantinib impurity D Cabozantinib impurity D
Neratinib Impurity 3 Neratinib Impurity 3
Ranitidine Impurity D Ranitidine Impurity D C13H22N4O3S
Metoprolol IMpurity 5 Metoprolol IMpurity 5 C15H25NO3
Mirabegron Impurity 2 Mirabegron Impurity 2
Pemetrexed Impurity 1 Pemetrexed Impurity 1 1644287-26-2 C20H21N5O8
Plerixafor Impurity B Plerixafor Impurity B
Tolvaptan impurity3 Tolvaptan impurity3
Vonoprazan Impurity 7 Vonoprazan Impurity 7
Cefazolin impurity F Cefazolin impurity F
Apremilast Impurity 3 Apremilast Impurity 3 88687-92-7 C16H10N2O8
Apixaban Impurity 8 Apixaban Impurity 8 1777781-49-3 C24H23N5O4
Ritodrine BP Impurity D Ritodrine BP Impurity D
Rivaroxaban Impurity 19 Rivaroxaban Impurity 19
Topiroxostat Impurity 4 Topiroxostat Impurity 4 1379342-46-7 C8H8N2O3
Ertapenem impurity 1 Ertapenem impurity 1
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl methacrylate (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl methacrylate C26H36NO3
Flomoxef Impurity 3 Flomoxef Impurity 3
Ropivacaine impurity Ropivacaine impurity 1105704-96-8 C12H14N2O3
Agomelatine Impurity 1 Agomelatine Impurity 1 1352139-51-5 C15H19NO2
Diquafosol Impurity 1 Diquafosol Impurity 1 26184-65-6 C18H24N4O17P2
Milnacipran Impurity 3 Milnacipran Impurity 3 1353644-50-4 C15H20ClNO
L-Glutamic acid 1-ethyl ester L-Glutamic acid 1-ethyl ester 52454-78-1 C7H13NO4
Methyl 2-Hydroxy-2-(Thiophen-2-Yl)-2-(Thiophen-3-Yl)Acetate Methyl 2-Hydroxy-2-(Thiophen-2-Yl)-2-(Thiophen-3-Yl)Acetate 28748-67-6 C11H10O3S2
6,7-Dihydro-N-methyl-N-[(3R,4R)-4-methyl-3-piperidinyl]-5H-pyrrolo[2,3-d]pyrimidin-4-amine 6,7-Dihydro-N-methyl-N-[(3R,4R)-4-methyl-3-piperidinyl]-5H-pyrrolo[2,3-d]pyrimidin-4-amine 1812890-23-5 C13H21N5
Sacubitril Impurity 72 Sacubitril Impurity 72 1361408-16-3 C23H27NO4
(1R,2S,3R)-Aprepitant (1R,2S,3R)-Aprepitant 1185502-97-9 C23H21F7N4O3
Clemastine Clemastine 108825-05-4 C21H26ClNO2
4-chloro-7-methoxyquinoline-6-carboxylic acid 4-chloro-7-methoxyquinoline-6-carboxylic acid 771464-30-3 C11H8ClNO3
ethyl (41S,13aR)-13a-ethyl-2,3,41,5,6,13a-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate ethyl (41S,13aR)-13a-ethyl-2,3,41,5,6,13a-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 85647-43-4 C22H26N2O2
methyl (41R,12R,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41R,12R,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 38990-16-8 C21H26N2O3
Dolutegravir Impurity 3 Dolutegravir Impurity 3 1973402-05-9 C20H19F2N3O5
Cistracurium Besylate EP Impurity D Cistracurium Besylate EP Impurity D 1075726-88-3 C31H39NO9S
(R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]-3-chloropropan-1-one (R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]-3-chloropropan-1-one 1288338-96-4 C25H25ClN6O2
Bendamustine Impurity 8 Bendamustine Impurity 8 1797881-48-1 C14H19Cl2N3O2
FeBuxostat Impurity 32 FeBuxostat Impurity 32 1805770-41-5 C12H12N2O
Edoxaban Impurity 9(1R,2S,4S) Edoxaban Impurity 9(1R,2S,4S) 2024614-15-9 C21H30ClN5O5
Rivaroxaban Impurity 22 Rivaroxaban Impurity 22 1350288-77-5 C19H18ClN3O5S
Rivaroxaban Impurity 27 Rivaroxaban Impurity 27 1369969-44-7 C21H21N3O5
Abiraterone Impurity 9 Abiraterone Impurity 9 165334-72-5 C24H31NO
Gliclazide Impurity A Gliclazide Impurity A
(2R,4S)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoate (2R,4S)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoate 752174-62-2 C20H25NO2
EMpagliflozin  iMpurity 12 EMpagliflozin iMpurity 12
(2S,4R)-Teneligliptin (2S,4R)-Teneligliptin 1404559-15-4 C22H30N6OS
Daclatasvir Impurity Daclatasvir Impurity 1417333-83-5 C40H50N8O6
(3aS,12bS)-2-Methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (3aS,12bS)-2-Methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole 65576-39-8 C17H17NO
1-[2-[(3,4-diMethylphenyl)thio]phenyl]- Piperazine 1-[2-[(3,4-diMethylphenyl)thio]phenyl]- Piperazine 1293489-74-3 C18H22N2S
2-(7-Methoxy-3,4-dihydronaphthalen-1-yl)acetic acid 2-(7-Methoxy-3,4-dihydronaphthalen-1-yl)acetic acid 27533-69-3 C13H14O3
N-acetyl-N-(2-(7-Methoxynaphthalen-1-yl)ethyl)acetaMide N-acetyl-N-(2-(7-Methoxynaphthalen-1-yl)ethyl)acetaMide 1379005-34-1 C17H19NO3
N-acetyl-N-(2-(7-Methoxynaphthalen-1-yl)ethyl)acetaMide N-acetyl-N-(2-(7-Methoxynaphthalen-1-yl)ethyl)acetaMide 1379005-34-1 C17H19NO3
carfilzoMib iMpurity -A carfilzoMib iMpurity -A
(3S,4R)-1-(4-fluorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one (3S,4R)-1-(4-fluorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one 1593543-00-0 C24H21F2NO3
ethyl N-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)Methyl)-N-pentanoyl-L-valinate ethyl N-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)Methyl)-N-pentanoyl-L-valinate 1111177-30-0 C26H33N5O3
Rosuvastatin EP impurity A Rosuvastatin EP impurity A 1714147-50-8 C25H34FN3NaO7S*
4-(3,4-DICHLOROPHENYL)-3,4-DIHYDRO-2H-NAPHTHALEN-1-ONE OXIME 4-(3,4-DICHLOROPHENYL)-3,4-DIHYDRO-2H-NAPHTHALEN-1-ONE OXIME 152642-35-8 C16H13Cl2NO
3-Pyridinecarboxylic acid, 6-(4-carboxy-1-piperidinyl)-5-chloro- 3-Pyridinecarboxylic acid, 6-(4-carboxy-1-piperidinyl)-5-chloro- 958457-83-5 C12H13ClN2O4
Linagliptin Impurity C Linagliptin Impurity C
Parecoxib Impurity B Parecoxib Impurity B
Vildagliptin impurity E Vildagliptin impurity E
3-propylisobenzofuran-1(3H)-one 3-propylisobenzofuran-1(3H)-one 72424-08-9 C11H12O2
Axitinib Sulfonyl Axitinib Sulfonyl 1348536-59-3 C22H18N4O3S
Atracurium Impurity B Atracurium Impurity B 87046-74-0
(R)-4-fluoro-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)-4-fluoro-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 C23H24FN7O4
2-(2-fluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol 2-(2-fluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol C13H13FN6O
Dapagliflozin Impurity 10 Dapagliflozin Impurity 10 960404-86-8 C21H25ClO7
Ibrutinib Impurity 6 Ibrutinib Impurity 6 1917333-91-5 C28H26N6O3
Imatinib Impurity 5 Imatinib Impurity 5
Mirabegron Impurity 8 HCl Mirabegron Impurity 8 HCl 1684452-81-0 C21H24N4O2S
Regorafenib Impurity 2 Regorafenib Impurity 2
Vonoprazan Impurity 5 Vonoprazan Impurity 5
Bendamustine Bendamustine 1219709-86-0 C14H18ClN3O2
Dapagliflozin Impurity E Dapagliflozin Impurity E
Febuxostat Impurity 14 Febuxostat Impurity 14 1335202-60-2 C15H16N2OS
Kaempferol 3-robinoside 7-glucoside Kaempferol 3-robinoside 7-glucoside 114924-89-9 C33H40O20
Vitexin 7-glucoside Vitexin 7-glucoside 35109-95-6 C27H30O15
2-amino-9-((1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 2-amino-9-((1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 1367369-77-4 C12H15N5O3
Carfilzomib Impurity B Carfilzomib Impurity B
Hesperidin dihydrochalcone Hesperidin dihydrochalcone 35573-79-6 C28H36O15
Alogliptin Imp.12 Alogliptin Imp.12 2749281-73-8 C25H25N5O3
Ornidazole Impurity 1 Ornidazole Impurity 1 1100750-18-2
Norpterosin B glucoside Norpterosin B glucoside 1226785-88-1 C19H26O7
Medetomidine Impurity 14 Medetomidine Impurity 14 79924-14-4 C13H16N2
Tenofovir Disoproxil Impurity B Tenofovir Disoproxil Impurity B 36817-69-3 C8H11N5O
Ipragliflozin  IMP Ipragliflozin IMP
Cefathiamidine Impurity D Cefathiamidine Impurity D
Cefazolin Impurity C (EP) Cefazolin Impurity C (EP)
Cefdinir Impurity H (CP) Cefdinir Impurity H (CP)
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