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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
Afatinib Impurity 18 Afatinib Impurity 18 2316847-95-5 C22H20ClFN4O4
Ivabradine Impurity 1 Hydrochloride Ivabradine Impurity 1 Hydrochloride 85175-52-6 C16H25ClN2O3
SofosBuvir Impurity 3 SofosBuvir Impurity 3
phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate 417722-95-3 C24H18ClN3O5
Canagliflozin Impurity 10 Canagliflozin Impurity 10 1672658-93-3 C24H25FO6S
Canagliflozin Impurity F Canagliflozin Impurity F
Empagliflozin impurity E Empagliflozin impurity E
Fasudil Impurity 6 Fasudil Impurity 6 2044706-58-1 C11H11NO3S
Ibrutinib Impurity 11 Ibrutinib Impurity 11
Nintedanib impurity I Nintedanib impurity I 334951-61-0 C30H31N5O4
(Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylic acid compound with 3-benzoyl-2-oxoindoline-6-carboxylic acid (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylic acid compound with 3-benzoyl-2-oxoindoline-6-carboxylic acid 1253768-91-0 C16H11NO4
Everolimus Related Compound 3 Everolimus Related Compound 3 147438-30-0 C32H49NO9
(R)-isopropyl 2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate (R)-isopropyl 2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate 1627824-09-2 C18H17F5NO5P
Cefuroxime Sodium EP Impurity C Cefuroxime Sodium EP Impurity C 69822-88-4 C15H15N3O6S
Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid 76812-49-2 C23H20ClNO8
Cefuroxime Sodium EP Impurity G Cefuroxime Sodium EP Impurity G 97232-98-9 C17H17N3O8S
2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone 2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone 1244949-62-9 C11H14ClN3O
Cetirizine 3-Chloro Impurity Cetirizine 3-Chloro Impurity 1232460-31-9 C21H25ClN2O3
N-Ethoxycarbonyl Ciprofloxacin N-Ethoxycarbonyl Ciprofloxacin 93594-29-7 C20H22FN3O5
Norepinephrine Tartrate Impurity G Norepinephrine Tartrate Impurity G 13062-58-3 C22H21NO3
Vortioxetine Impurity 1 Vortioxetine Impurity 1 1293489-71-0 C17H20N2S
4-bromo-2-nitropyridine 4-bromo-2-nitropyridine 909712-10-3 C5H3BrN2O2
Acemetacin Impurity F Acemetacin Impurity F
1,3-Bis(1H-1,2,4-triazol-1-yl)-2-propanone 1,3-Bis(1H-1,2,4-triazol-1-yl)-2-propanone 98414-56-3 C7H8N6O
2-[[(3aR,4S,6R,6aS)-6-(7-azanyl-5-propylsulfanyl-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,2-dimethyl-4,5,6,6a-tetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl]oxy]ethanol 2-[[(3aR,4S,6R,6aS)-6-(7-azanyl-5-propylsulfanyl-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,2-dimethyl-4,5,6,6a-tetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl]oxy]ethanol 1354945-69-9 C17H26N6O4S
Vonoprazan Impurity E Vonoprazan Impurity E
2-(2-aminobut-3-enyl)propanedioic acid 2-(2-aminobut-3-enyl)propanedioic acid 1378466-25-1 C7H11NO4
Disalicylimide Disalicylimide 1972-71-0 C14H11NO4
Diltiazem impurity Diltiazem impurity 115992-91-1 C17H18N2O3S
Raloxifene EP IMpurity Raloxifene EP IMpurity 1700655-64-6 C13H15ClN2O2S
Parecoxib Impurity M Parecoxib Impurity M
(-)-Lyoniresinol 9'-O-glucoside (-)-Lyoniresinol 9'-O-glucoside 143236-02-6 C28H38O13
Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro- Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro- 1648791-23-4 C29H43N5
Linagliptin Impurity O Linagliptin Impurity O
Linagliptin Impurity T Linagliptin Impurity T
(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide C18H22FN5O3
Apremilast Impurity 2 Apremilast Impurity 2
Etoricoxib Impurity 16 Etoricoxib Impurity 16
Ibrutinib Impurity 2 Ibrutinib Impurity 2
Mirabegron Impurity 14 Mirabegron Impurity 14
Vonoprazan Impurity 1 Vonoprazan Impurity 1 881732-90-7 C17H17N3O2S
Atenolol EP Impurity Atenolol EP Impurity C14H22N2O3
Cinacalcet Impurity 20 Cinacalcet Impurity 20
Dapagliflozin Impurity 11 Dapagliflozin Impurity 11
Dasatinib Impurity C Dasatinib Impurity C
Etoricoxib impurity Q Etoricoxib impurity Q 292067-97-1 C18H15ClN2S
Flucloxacillin Impurity Flucloxacillin Impurity
Fluorometholone Impurity Fluorometholone Impurity 2796-99-8 C23H31FO7S
Verapamil Impurity Verapamil Impurity 1551304-28-9 C12H19NO2
Donepezil Impurity 8 Donepezil Impurity 8 1808997-65-0 C18H23NO4
Rivaroxaban Impurity 23 Rivaroxaban Impurity 23
(Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide (Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide 1450758-21-0 C5H6N4O2S
Fosfomycin Trometamol impurity C Fosfomycin Trometamol impurity C 23001-39-0 C4H12NO6P
(R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate (R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate C22H23FN2O5
Bendamustine Deschloro Dimer Impurity Bendamustine Deschloro Dimer Impurity 1391052-61-1 C32H44N6O7
Benzenepropanoic acid, β-aMino-α-hydroxy-, Methyl ester, (αR,βR)- Benzenepropanoic acid, β-aMino-α-hydroxy-, Methyl ester, (αR,βR)- 157722-44-6 C10H13NO3
Benzenebutanoicacid,b-aMino-2,4,5-trifluoro-,Methylester,(bR)- Benzenebutanoicacid,b-aMino-2,4,5-trifluoro-,Methylester,(bR)- 881995-69-3 C11H12F3NO2
Avanafil iMpurity 2 Avanafil iMpurity 2
Bisoprolol IMpurity Bisoprolol IMpurity 2226263-67-6 C18H31NO4
Decitabine iMpurity 5 Decitabine iMpurity 5
Erlotinib iMpurity 3 Erlotinib iMpurity 3 328528-74-1 C20H22BrN3O4
LevetiracetaM IMpurity 3 LevetiracetaM IMpurity 3 1543353-92-9 C8H15NO4
Sofosbuvir IMpurity Sofosbuvir IMpurity
(3R,4R,5R)-4-(1-Ethylpropoxy)-3-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester (3R,4R,5R)-4-(1-Ethylpropoxy)-3-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester 204254-94-4 C15H26O7S
9,11-Anhydrobudesonide 9,11-Anhydrobudesonide 313474-58-7 C25H32O5
iperazineacetic acid, 4-[(4- chlorophenyl)phenylMethyl]- iperazineacetic acid, 4-[(4- chlorophenyl)phenylMethyl]- 113740-61-7 C19H21ClN2O2
EveroliMus-d4 EveroliMus-d4 1338452-54-2 C53H79D4NO14
(2R,3R,4R,5R)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-chloro-4-Methyltetrahydrofuran-3-yl benzoate (2R,3R,4R,5R)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-chloro-4-Methyltetrahydrofuran-3-yl benzoate 1496551-70-2 C31H26ClN3O7
1-((2R,3S,4R,5R)-3,4-dihydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 1-((2R,3S,4R,5R)-3,4-dihydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 114262-49-6 C10H14N2O6
4-(4-(3-(4-chloro-3-(trifluoroMethyl)phenyl)ureido)-3-fluorophenoxy)-2-(MethylcarbaMoyl)pyridine 1-oxide 4-(4-(3-(4-chloro-3-(trifluoroMethyl)phenyl)ureido)-3-fluorophenoxy)-2-(MethylcarbaMoyl)pyridine 1-oxide 835621-11-9 C21H15ClF4N4O4
D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-[[4-[4-[4-[1-(1-ethylpropyl)-1,5-dihydro-5-oxo-4H-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]Methyl]-1-(1H-1,2,4-triazol-1-yl)- D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-[[4-[4-[4-[1-(1-ethylpropyl)-1,5-dihydro-5-oxo-4H-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]Methyl]-1-(1H-1,2,4-triazol-1-yl)- 161532-65-6 C37H42F2N8O3
1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-one 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-one 186521-85-7 C15H19ClO
NSC 351869 NSC 351869 31350-27-3 C14H14N2O4
4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-iodo-2-methoxybenzamide 4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-iodo-2-methoxybenzamide 176849-91-5 C15H22IN3O2
N,N'-Vis[2-(3,4-dimethoxyphenyl)ethyl]-N,N'-dimethyl-1,3-propanediamine dihydrochloride N,N'-Vis[2-(3,4-dimethoxyphenyl)ethyl]-N,N'-dimethyl-1,3-propanediamine dihydrochloride 63434-11-7 C25H39ClN2O4
2-Bromo-3'-chloropropiophenone 2-Bromo-3'-chloropropiophenone 34911-51-8 C9H8BrClO
(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid hydrochloride (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid hydrochloride 1038924-71-8 C18H22ClNO2
(3R,4S,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)-2-methoxyoxane-3,4,5-triol (3R,4S,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)-2-methoxyoxane-3,4,5-triol 915095-96-4 C24H29ClO8
Doxorubicin Imp B HBr salt Doxorubicin Imp B HBr salt 148218-14-8 C29H35Br2NO11
but-3-en-2-one compound with imidazo[1,2-a]pyridine (1:1) but-3-en-2-one compound with imidazo[1,2-a]pyridine (1:1) 106730-70-5 C13H15N3O
(R)-2-(Boc-aMino)-2-phenylethyl 4-Methylbenzenesulfonate (R)-2-(Boc-aMino)-2-phenylethyl 4-Methylbenzenesulfonate 126610-77-3 C20H25NO5S
(2R,3R,4R,5S)-5-(4-chloro-3-(4-((S)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-2-(2-hydroxyethyl)tetrahydrofuran-2,3,4-triol (2R,3R,4R,5S)-5-(4-chloro-3-(4-((S)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-2-(2-hydroxyethyl)tetrahydrofuran-2,3,4-triol C23H27ClO7
Pyrido[2,3-d]pyriMidin-7(8H)-one, 8-cyclopentyl-5-Methyl-2-[[5-(1-piperazinyl)-2-pyridinyl]aMino]-, hydrochloride (1:) Pyrido[2,3-d]pyriMidin-7(8H)-one, 8-cyclopentyl-5-Methyl-2-[[5-(1-piperazinyl)-2-pyridinyl]aMino]-, hydrochloride (1:) 571189-66-7 C22H28ClN7O
Olaparib iMpurity Olaparib iMpurity
(2S,3R,4R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-5-((S)-1,2-dihydroxyethyl)tetrahydrofuran-3,4-diol (2S,3R,4R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-5-((S)-1,2-dihydroxyethyl)tetrahydrofuran-3,4-diol C21H25ClO6
(R)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl) butanoate .(R)-2-hydroxy-2-phenylacetate (R)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl) butanoate .(R)-2-hydroxy-2-phenylacetate 1253055-94-5 C19H20F3NO5
Olaparib iMpurity A Olaparib iMpurity A
(1S,2S,3R,5S)-3-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol C14H20ClN5O4S
Posaconazole iMpurity 5 Posaconazole iMpurity 5
APST-ZA APST-ZA 635705-72-5 C20H22N2O6S
Topiroxostat Impurity 5 Topiroxostat Impurity 5 1199273-82-9 C14H7N7
Clopidogrel impurity reference substance Clopidogrel impurity reference substance C15H14ClNO2S
Vildagliptin Impurity Vildagliptin Impurity
Aloeemodin-ω-O-β-D-glucopyranoside Aloeemodin-ω-O-β-D-glucopyranoside 29010-56-8 C21H20O10
ethyl 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate ethyl 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate 2029205-62-5 C26H25ClN4O4
1-Butanaminium, N,N,N-tributyl-, (1R,2S,5R)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl sulfate 1-Butanaminium, N,N,N-tributyl-, (1R,2S,5R)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl sulfate 1192651-80-1 C23H46N4O6S
Dihydroxyoxaliplatin(Oxaliplatin Impurity Ⅲ) Dihydroxyoxaliplatin(Oxaliplatin Impurity Ⅲ)
cefditoren E-isomer(C=C) cefditoren E-isomer(C=C)
Mixture of Lamivudine Impurity Ⅳ and Impurity Ⅴ Mixture of Lamivudine Impurity Ⅳ and Impurity Ⅴ
2-Ethoxybenzimidohydrazide 2-Ethoxybenzimidohydrazide 889943-46-8 C9H13N3O
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