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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
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
Doxorubicin Impurity 6 Doxorubicin Impurity 6 69429-21-6 C26H27NO11
Etoricoxib Impurity 11 Etoricoxib Impurity 11 202409-31-2 C17H13ClN2O2S
Levofloxacin Tetrafluoro Impurity 1 Levofloxacin Tetrafluoro Impurity 1 110548-02-2 C15H15F4NO4
Penicillin F Potassium Salt Penicillin F Potassium Salt 97299-13-3 C14H21KN2O4S
Olaparib Impurity 31 Olaparib Impurity 31 458535-34-7 C12H18N2O2
Macitentan impurity A Macitentan impurity A 441798-25-0 C17H16Br2N6O4S
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
Abiraterone Impurity 9 Abiraterone Impurity 9 165334-72-5 C24H31NO
Gliclazide Impurity A Gliclazide Impurity A
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
2-(1,3,2-Dioxaborinan-2-yl)benzamide 2-(1,3,2-Dioxaborinan-2-yl)benzamide 2377611-18-0 C10H12BNO3
Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) 5740-62-5 C24H32O6
(1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate (1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate 229614-51-1 C16H30N4O4
Bis(4-fluorobenzyl)aMine, 97% Bis(4-fluorobenzyl)aMine, 97% 134227-41-1 C14H13F2N
(3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester (3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester 1292296-09-3 C38H52N6O7
L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride 142963-69-7 C14H23ClN6O4
8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 432543-89-0 C19H20Cl2N2
1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 141745-71-3 C25H29N3O2
PF 2825 PF 2825 153012-65-8 C21H28N2O5S
3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 444057-64-1 C24H27ClN4O6S2
Ertapenem Dimer Form D Impurity Ertapenem Dimer Form D Impurity 1199797-41-5 C44H50N6O14S2
S 00218 S 00218 92700-82-8 C15H22N2O4
2-Methyl-2-(4-vinylphenyl)propanoic acid 2-Methyl-2-(4-vinylphenyl)propanoic acid 1256584-72-1 C12H14O2
Loratadine IMpurity D Loratadine IMpurity D C22H23ClN2O2
PeMetrexed EP IMpurity A PeMetrexed EP IMpurity A 869791-42-4 C21H23N5O6
Itraconazole EP IMpurity G Itraconazole EP IMpurity G
(1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride (1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride 1402222-66-5 C9H10ClF2N
IMp. E (EP): 1,4-Bis(diphenylMethyl)piperazine IMp. E (EP): 1,4-Bis(diphenylMethyl)piperazine 216581-01-0 C30H30N2
21-Dehydro-6α-Methyl Prednisolone 21-Dehydro-6α-Methyl Prednisolone 58636-50-3 C22H28O5
α-Hydroxy Flurbiprofen α-Hydroxy Flurbiprofen 61466-95-3 C15H13FO3
5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate 5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate 1391194-45-8 C20H21NO3S
9-AcridinaMine, 6-chloro-2-ethoxy- 9-AcridinaMine, 6-chloro-2-ethoxy- 855939-48-9 C15H13ClN2O
1-(6-Methylpyridin-3-yl)-2-(4-(Methylthio)phenyl)ethanone 1-(6-Methylpyridin-3-yl)-2-(4-(Methylthio)phenyl)ethanone 221615-72-1 C15H15NOS
Edaravone Edaravone 68195-63-1 C30H26N6O3
Caspofungin IMpurity A Caspofungin IMpurity A 1202167-57-4 C51H86N10O15
DesdifluoroMethoxy Hydroxy Pantoprazole DesdifluoroMethoxy Hydroxy Pantoprazole 1261238-06-5 C15H15N3O4S
Levofloxacin Hydroxy Acid Levofloxacin Hydroxy Acid 1036016-10-0 C18H21F2N3O4
N-(4,5-Dihydro-1H-iMidazol-2-yl)-6-quinoxalinaMine N-(4,5-Dihydro-1H-iMidazol-2-yl)-6-quinoxalinaMine 91147-43-2 C11H11N5
Nor Lidocaine Hydrochloride Nor Lidocaine Hydrochloride 7729-94-4 C12H19ClN2O
rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate 136310-66-2 C18H19NO3S2
(11β)-17-(Acetyloxy)-11-[4-(diMethylaMino)phenyl]-3-hydroxy-19-norpregna-1,3,5(10)-trien-20-one (11β)-17-(Acetyloxy)-11-[4-(diMethylaMino)phenyl]-3-hydroxy-19-norpregna-1,3,5(10)-trien-20-one 709615-25-8 C30H37NO4
4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 1187954-57-9 C32H37NO3
(2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride (2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride 1370331-33-1 C8H17NO5
(3S,5R)-Rosuvastatin (3S,5R)-Rosuvastatin 1242184-42-4 C22H28FN3O6S
(S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide (S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide 119714-13-5 C10H16N2O3S
Afatinib IMpurity I Afatinib IMpurity I 1637254-93-3 C22H19BrClFN4O3
Aripiprazole iMpurity 2 Aripiprazole iMpurity 2 1424857-93-1 C14H18Cl2N2
Avanafil IMpurity 6 Avanafil IMpurity 6
Cefoxitin iMpurity F (S-Methoxy cefoxitin) Cefoxitin iMpurity F (S-Methoxy cefoxitin)
Clopidogrel IMpurity 1 Clopidogrel IMpurity 1 C15H14ClNO2S
LincoMycin iMpurity A LincoMycin iMpurity A
Posaconazole iMpurity 1 Posaconazole iMpurity 1
Riociguat IMpurtiy Riociguat IMpurtiy 2920299-23-4
TelMisartan IMpurity E TelMisartan IMpurity E
IverMectin B1 Mono-sugar Derivative IverMectin B1 Mono-sugar Derivative 71837-27-9 C41H62O11
Norpterosin B glucoside Norpterosin B glucoside 1226785-88-1 C19H26O7
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