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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
Rabeprazole Impurity 2 Rabeprazole Impurity 2 1807988-36-8 C18H19N3O4
Tenofovir Related Compound 14 Tenofovir Related Compound 14 1244022-52-3 C8H11N5O
N-(2-methyl-5-nitrophenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide N-(2-methyl-5-nitrophenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide C18H15N5O3
N-(5-(benzyl(methyl)amino)-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide N-(5-(benzyl(methyl)amino)-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide C25H23N5O
1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxylic acid 1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxylic acid 956011-26-0 C14H10FN3O2
Nicorandil Impurity 4 Dinitrate Nicorandil Impurity 4 Dinitrate 1798026-96-6 C16H17N5O5
Ethanone, 1-[3,5-bis(phenylmethoxy)phenyl]-2-[(1,1-dimethylethyl)(phenylmethyl)amino]-, sulfate (1:1) Ethanone, 1-[3,5-bis(phenylmethoxy)phenyl]-2-[(1,1-dimethylethyl)(phenylmethyl)amino]-, sulfate (1:1) 52144-93-1 C33H37NO7S
5-HYDROXY LANSOPRAZOLE 5-HYDROXY LANSOPRAZOLE 131926-98-2 C16H14F3N3O3S
ergosteryl 3-beta-D-glucoside ergosteryl 3-beta-D-glucoside 130155-33-8 C34H54O6
(3S,5R)-4-[5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-2-oxopyrrolidin-1-yl]-4-oxobutanoic acid (3S,5R)-4-[5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-2-oxopyrrolidin-1-yl]-4-oxobutanoic acid C22H23NO4
Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-4-[4-(propan-2-yloxy)-4-oxobutanamido]-2-methylbutanoate Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-4-[4-(propan-2-yloxy)-4-oxobutanamido]-2-methylbutanoate C27H35NO5
1-METHYL-5-MERCAPTOTETRAZOLE, SODIUM SALT 1-METHYL-5-MERCAPTOTETRAZOLE, SODIUM SALT 51138-06-8 C2H3N4NaS
LCZ Impurity LCZ Impurity 753421-85-1 C20H25NO2
1,1'-[1,3-Propanediylbis(oxy)]bis[2,5-dimethylbenzene] 1,1'-[1,3-Propanediylbis(oxy)]bis[2,5-dimethylbenzene] 415724-02-6 C19H24O2
4-FORMYLCINNAMIC ACID 4-FORMYLCINNAMIC ACID 66885-68-5 C10H8O3
Cabozantinib Impurity H Cabozantinib Impurity H
Clopidogrel Impurity 11 Clopidogrel Impurity 11 C15H14ClNO2S
Medetomidine Impurity 3 Medetomidine Impurity 3 104245-83-2 C10H13Cl
2-(((3aS,4R,6S,6aR)-6-((5-amino-6-chloro-2-(propylthio)pyrimidin-4-yl)amino)-2,2-dimethyltetrahydro-4H-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethan-1-ol 2-(((3aS,4R,6S,6aR)-6-((5-amino-6-chloro-2-(propylthio)pyrimidin-4-yl)amino)-2,2-dimethyltetrahydro-4H-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethan-1-ol C17H27ClN4O4S
Clindamycin  impurity Clindamycin impurity 198080-64-7 C18H32N2O5S
Digoxin impurity Digoxin impurity
Lamivudine impurity Lamivudine impurity
Levothyroxine Sodium  impurity Levothyroxine Sodium impurity 27566-09-2 C14H21NO4
Dexchlorpheniramine impurity Dexchlorpheniramine impurity 73775-50-5 C12H15ClN2
(S)-N-(2-(1-(3-ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide (S)-N-(2-(1-(3-ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide 1384441-38-6 C21H22N2O7S
(1R,2S,3S)-Aprepitant (1R,2S,3S)-Aprepitant 172822-28-5 C23H21F7N4O3
(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole compound with 6-methoxy-1-((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole (1:1) (((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole compound with 6-methoxy-1-((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole (1:1)
6-benzyloxy-8-((R)-2-chloro-1-hydroxy-ethyl)-4H-benzo[1,4]-oxazin-3-one 6-benzyloxy-8-((R)-2-chloro-1-hydroxy-ethyl)-4H-benzo[1,4]-oxazin-3-one 869478-11-5 C17H16ClNO4
ethyl (41R,13aS)-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 (41R,13aS)-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 77549-94-1 C22H26N2O2
Dolutegravir Impurity 2 Dolutegravir Impurity 2
Lesinurad Impurity J Lesinurad Impurity J 1210330-64-5 C14H10BrN3O2S
Neratinib Impurity 4 Neratinib Impurity 4 1144516-18-6 C31H32ClN6O3+
Avibactam Impurity 3(2R,5S) Avibactam Impurity 3(2R,5S) 1383814-68-3 C7H12N3NaO6S
Linagliptin Impurity C Linagliptin Impurity C 1791405-13-4 C15H20N6O2
1,1-Cyclopropanedicarboxamide,N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N'-phenyl- 1,1-Cyclopropanedicarboxamide,N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N'-phenyl- 849221-94-9 C28H25N3O5
methyl (41S,12S,13aS)-13a-ethyl-12-hydroxy-8-methoxy-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 (41S,12S,13aS)-13a-ethyl-12-hydroxy-8-methoxy-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 57430-34-9 C22H28N2O4
(R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]ethanone (R)-1-[3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]ethanone 1288338-95-3 C24H24N6O2
Amlodipine Impurity 17 Amlodipine Impurity 17 C26H31ClN2O8S
Edoxaban Impurity 12 (1R,2R,4S) Edoxaban Impurity 12 (1R,2R,4S)
Rivaroxaban Impurity 26 Rivaroxaban Impurity 26 1838133-00-8 C23H21Cl2N3O5S2
Erlotinib Erlotinib 938185-06-9 C16H11N3O2
methyl (41R,12S,13aS)-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,12S,13aS)-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 18374-18-0 C21H26N2O3
Brexpiprazole sulfoxide impurity Brexpiprazole sulfoxide impurity 1191900-51-2 C25H27N3O3S
Tofacitinib Impurity 35 Tofacitinib Impurity 35
Notoginsenoside FP2 Notoginsenoside FP2 1004988-75-3 C58H98O26
ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate 1884279-18-8 C18H17NO4S
N-methyl-1-(5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methanamine fumarate N-methyl-1-(5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methanamine fumarate 928325-82-0 C21H21N3O6S
Phenol, 2,4-dibromo-3-methyl- Phenol, 2,4-dibromo-3-methyl- 13321-75-0 C7H6Br2O
N-((4-FLUOROPHENYL)METHYL)ETHANAMIDE N-((4-FLUOROPHENYL)METHYL)ETHANAMIDE 86010-68-6 C9H10FNO
Benzenediazonium, 4-(ethoxycarbonyl)-, chloride Benzenediazonium, 4-(ethoxycarbonyl)-, chloride 2028-79-7 C9H9ClN2O2
2,4-Pteridinediamine,6-(methoxymethyl)- 2,4-Pteridinediamine,6-(methoxymethyl)- 40110-13-2 C8H10N6O
Fingolimod EP Impurity D Fingolimod EP Impurity D 780729-32-0 C21H37NO2
Pentanedioic acid, 2,4-diacetyl-3-(3-nitrophenyl)-, dimethyl ester Pentanedioic acid, 2,4-diacetyl-3-(3-nitrophenyl)-, dimethyl ester 89080-61-5 C17H19NO8
2-Thiazoleacetic acid,4-carboxy-2,5-dihydro-5-(4-hydroxybutylidene)-a-[(1R)-1-hydroxyethyl]-, disodium salt, (aS,2R,5Z)- (9CI) 2-Thiazoleacetic acid,4-carboxy-2,5-dihydro-5-(4-hydroxybutylidene)-a-[(1R)-1-hydroxyethyl]-, disodium salt, (aS,2R,5Z)- (9CI) 130609-10-8 C12H18NNaO6S
Ticagrelor Impurity N Ticagrelor Impurity N 1643378-47-5 C23H29FN6O4S
carbamic acid, n-[(1r,2r,5s)-5-[(dimethylamino)carbonyl]-2-hydroxycyclohexyl]-, 1,1-dimethylethyl ester carbamic acid, n-[(1r,2r,5s)-5-[(dimethylamino)carbonyl]-2-hydroxycyclohexyl]-, 1,1-dimethylethyl ester 929693-30-1 C14H26N2O4
Valaciclovir iMpurity Valaciclovir iMpurity
Erlotinib hydrochloride Impurity C Erlotinib hydrochloride Impurity C
Linagliptin Impurity B Linagliptin Impurity B
Parecoxib Impurity A Parecoxib Impurity A
Parecoxib Impurity F Parecoxib Impurity F
2-(4-Benzhydrylpiperazino)ethyl acetoacetate 2-(4-Benzhydrylpiperazino)ethyl acetoacetate 89226-49-3 C23H28N2O3
Axitinib Impurity a Axitinib Impurity a 1347304-18-0 C22H18N4O2S
Cycloocta[b]pyridine, 4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-2-(1-piperazinyl)- Cycloocta[b]pyridine, 4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-2-(1-piperazinyl)- 132811-84-8 C21H26FN3
Linagliptin Impurity W Linagliptin Impurity W
(R)-4-fluoro-2-((3-methyl-2,4-dioxo-6-(piperidin-3-ylamino)-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile (R)-4-fluoro-2-((3-methyl-2,4-dioxo-6-(piperidin-3-ylamino)-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile C18H20FN5O2
1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid C21H24FN3O4
ethyl 1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate ethyl 1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate C17H18FNO5
Dapagliflozin Impurity 1 Dapagliflozin Impurity 1
Ibrutinib Impurity 5 Ibrutinib Impurity 5
Imatinib Impurity 4 Imatinib Impurity 4 942514-62-7 C30H33N7O
Macitentan Impurity 2 Macitentan Impurity 2 2211054-90-7 C10H8Br2N4O2
(R)-2-amino-4-(2-((4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl) phenyl)amino)-2-oxoethyl)thiazole 3-oxide (R)-2-amino-4-(2-((4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl) phenyl)amino)-2-oxoethyl)thiazole 3-oxide 1884646-38-1 C21H24N4O3S
Nilotinib Impurity 7 Nilotinib Impurity 7 2119583-26-3 C27H20F3N7O
Regorafenib Impurity 1 Regorafenib Impurity 1
Regorafenib Impurity 6 Regorafenib Impurity 6 1187945-05-6 C20H12ClF4N3O4
Sofosbuvir Impurity 9 Sofosbuvir Impurity 9
Venlafaxine N-Oxide Impurity Venlafaxine N-Oxide Impurity 1021933-95-8 C16H25NO3
Vonoprazan Impurity 4 Vonoprazan Impurity 4
Vortioxetine Impurity 25 Vortioxetine Impurity 25 1639263-80-1 C18H22N2O2S
Cinacalcet Impurity B Cinacalcet Impurity B 66469-40-7 C19H19N
Dapagliflozin Impurity D Dapagliflozin Impurity D 2133407-75-5 C21H25ClO6
Escitalopram Impurity Escitalopram Impurity 91283-87-3 C18H14FNO3
Furosemide Imp.(EP) Furosemide Imp.(EP)
Nifuratel Impurity Nifuratel Impurity 167103-07-3 C6H5N3O4
Vinpocetine Impurity Vinpocetine Impurity 102341-40-2 C19H23N3O
2-amino-9-((1R,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 2-amino-9-((1R,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 1367369-81-0 C12H15N5O3
N-(3,4-dichlorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine N-(3,4-dichlorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine 2089650-13-3 C22H24Cl2N4O3
Moxifloxacin Impurity 8 Moxifloxacin Impurity 8
(3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid (3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid C33H35FN2O5
Olaparib Imp.2 Olaparib Imp.2
Ciprofloxacin impurity I Ciprofloxacin impurity I C17H18FN3O3
5-(4'-((2-butyl-4-chloro-5-(isopropoxymethyl)-1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole 5-(4'-((2-butyl-4-chloro-5-(isopropoxymethyl)-1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole 1332713-64-0 C25H29ClN6O
Afatinib Impurity L (Afatinib N-Oxide) Afatinib Impurity L (Afatinib N-Oxide)
Afatinib Impurity L (Afatinib N-Oxide) Afatinib Impurity L (Afatinib N-Oxide)
Mirabegron Deshydroxy Mirabegron Deshydroxy 1581284-82-3 C21H24N4OS
4-Thiazoleacetyl chloride, 2-amino-, monohydrochloride
4-Thiazoleacetyl chloride, 2-amino-, monohydrochloride 66313-72-2 C5H6Cl2N2OS
1,2-bis(bromomethyl)-4,5-dimethoxybenzene 1,2-bis(bromomethyl)-4,5-dimethoxybenzene 26726-81-8 C10H12Br2O2
Alvimopan Impurity 2 Alvimopan Impurity 2
Alvimopan Impurity 4 Alvimopan Impurity 4
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