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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
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
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
Methotrexate α-Methyl Ester Methotrexate α-Methyl Ester 66147-29-3 C21H24N8O5
O-Desethyl Azilsartan O-Desethyl Azilsartan 1442400-68-1 C23H16N4O5
17- Phenyl Trinor Prostaglandin F2α Methyl Amide 17- Phenyl Trinor Prostaglandin F2α Methyl Amide 155206-01-2 C24H35NO4
(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
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
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
Atomoxetine impurity D Atomoxetine impurity D 1643684-02-9 C17H21NO
(E)-2-(6-(methoxycarbonyl)-2-oxoindolin-3-ylidene)-2-phenylacetic acid (E)-2-(6-(methoxycarbonyl)-2-oxoindolin-3-ylidene)-2-phenylacetic acid C18H13NO5
8-Epi-cyanocobalamin 8-Epi-cyanocobalamin 41325-63-7 C63H88CoN14O14P
Lamivudine Impurity 2 Lamivudine Impurity 2 200396-21-0 C18H27N3O4S
Lamivudine Impurity 1 Lamivudine Impurity 1 1235712-40-9 C8H11N3O4S
Moxifloxacin Related Impurity 3 Moxifloxacin Related Impurity 3
Bisoprolol EP Impurity Q Bisoprolol EP Impurity Q 1346604-00-9 C16H27NO4
Levofloxacin N-Oxide Levofloxacin N-Oxide 117678-37-2 C18H20FN3O5
Oseltamivir EP Impurity A Oseltamivir EP Impurity A 1391047-93-0 C14H24N2O4
Quetiapine EP Impurity N Quetiapine EP Impurity N 1800291-86-4 C29H41N5O3S
Ceftazidime Impurity Ceftazidime Impurity
Chlorhexidine Digluconate Impurity N Chlorhexidine Digluconate Impurity N 152504-10-4 C15H25ClN8
S-Azetidin-3-yl ethanethioate HCl S-Azetidin-3-yl ethanethioate HCl 886615-18-5 C5H9NOS
Olaparib Impurity C Olaparib Impurity C
Olaparib Impurity F Olaparib Impurity F
Dapoxetine Impurity 4 Dapoxetine Impurity 4
Glycopyrrolate impurity 3 Glycopyrrolate impurity 3
Lamotrigine impurity B Lamotrigine impurity B
Ramosetron Impurity 3 Ramosetron Impurity 3
Loratadine Impurity 1 Loratadine Impurity 1 C22H23ClN2O2
Metoprolol IMpurity 6 Metoprolol IMpurity 6 C15H25NO3
Pitavastatin Impurity 5 Pitavastatin Impurity 5
Prasugrel Impurity C Prasugrel Impurity C
Trifluridine Impurity 2 Trifluridine Impurity 2
Cefazolin Impurity 4 Cefazolin Impurity 4
Vonoprazan Impurity 3 Vonoprazan Impurity 3
Cinacalcene Impurity I Cinacalcene Impurity I
Valsartan Impurity 2 Valsartan Impurity 2 C24H29N5O3
Istradefylline Impurity 2 Istradefylline Impurity 2
Etoricoxib Impurity 3 Etoricoxib Impurity 3
Apremilast Impurity 5 Apremilast Impurity 5 200710-04-9 C11H13NO4
Topiroxostat Imp.C Topiroxostat Imp.C
(3R,4S)-1-(4-chlorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one (3R,4S)-1-(4-chlorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one 1700622-08-7 C24H21ClFNO3
Rabeprazole Impurity 2 Rabeprazole Impurity 2 1163685-31-1 C11H15NO4
Regorafenib Impurity 8 Regorafenib Impurity 8
Flomoxef Impurity 5 Flomoxef Impurity 5 134237-56-2 C25H23ClF2N2O6S
Ranitidine  impurity Ranitidine impurity 94167-82-5 C10H18N2O
nicergoline impurity E nicergoline impurity E
ethyl(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(4-ethoxy-4-oxobutanamido)-2-methylpentanoate ethyl(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(4-ethoxy-4-oxobutanamido)-2-methylpentanoate C26H33NO5
Tacrolimus Impurity C Tacrolimus Impurity C
Levodopa impurity 5 Levodopa impurity 5
(R)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide (R)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide 1223404-68-9 C21H22F2N6O2
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
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