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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
Revefenacin Impurity 21 Revefenacin Impurity 21
tert-Butyl 4-(6-(6-bromo-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydro-pyrido(2,3-d)pyrimidin-2-ylamino)-pyridin-3-yl)-piperazine-1-carboxylate tert-Butyl 4-(6-(6-bromo-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydro-pyrido(2,3-d)pyrimidin-2-ylamino)-pyridin-3-yl)-piperazine-1-carboxylate 571188-82-4 C27H34BrN7O3
Hesperidin methylchalcone Hesperidin methylchalcone 24292-52-2 C29H36O15
Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide 70381-75-8 C12H13Cl2N3O2.BrH
4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro- 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro- 79617-95-1 C17H17Cl2N
Avatrombopag Impurity 77 Avatrombopag Impurity 77
methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate
N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity A(USP) Ertapenem Impurity A(USP)
D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel- D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel- 2740644-40-8 C14H22N2O6
2-hydroxy-3-oxobutyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate 2-hydroxy-3-oxobutyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate
Ivabradine Bisbenzazepine Analog Ivabradine Bisbenzazepine Analog 2731089-65-7 C27H34N2O6
2-(2-ethoxy-3-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one 2-(2-ethoxy-3-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one
Bumetanide Photodegradable Impurity 15 Bumetanide Photodegradable Impurity 15
Bisoprolol Impurity 48 Bisoprolol Impurity 48
Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-amino-2-hydroxy-, methyl ester, (1S,2S,3R,4R)-, mono(trifluoroacetate) (salt) (9CI) Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-amino-2-hydroxy-, methyl ester, (1S,2S,3R,4R)-, mono(trifluoroacetate) (salt) (9CI) 357448-34-1 C17H29F3N2O6
Dobutamine Impurity 16 Dobutamine Impurity 16
Faropenem Impurity AB Faropenem Impurity AB
(-)-menthyl benzoate (-)-menthyl benzoate 6284-35-1 C17H24O2
4,4'-iminodiphenol 4,4'-iminodiphenol 1752-24-5 C12H11NO2
methyl 4-hydroxy-2-oxopyrrolidine-1-acetate methyl 4-hydroxy-2-oxopyrrolidine-1-acetate 85614-52-4 C7H11NO4
Pemetrexed Impurity 42 Pemetrexed Impurity 42
2-(6-Aminopurin-9-yl)ethanol 2-(6-Aminopurin-9-yl)ethanol 707-99-3 C7H9N5O
9-Azabicyclo[3.3.1]Nonane-9-Acetic Acid, 3-(Ethoxycarbonyl)-7-Oxo-, Ethyl Ester 9-Azabicyclo[3.3.1]Nonane-9-Acetic Acid, 3-(Ethoxycarbonyl)-7-Oxo-, Ethyl Ester 115956-03-1 C15H23NO5
Cefathiamidine Impurity F Cefathiamidine Impurity F
1-(Bromophenylmethyl)-4-chlorobenzene 1-(Bromophenylmethyl)-4-chlorobenzene 948-54-9 C13H10BrCl
1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 193902-78-2 C14H20N4O4
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate
Relugolix Impurity 25 Relugolix Impurity 25
Lumateperone Impurity 5 Lumateperone Impurity 5
Sugammadex Sodium Impurity ORG139131-1 Sugammadex Sodium Impurity ORG139131-1
2-[4-(Azidomethyl)phenyl]benzoic acid 2-[4-(Azidomethyl)phenyl]benzoic acid
2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 88150-46-3 C20H23ClN4O5
((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt ((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt
Brivaracetam Impurity 56 Brivaracetam Impurity 56
Oxytocin Impurity 3 Oxytocin Impurity 3
Rosuvastatin Impurity 158 Rosuvastatin Impurity 158
Rosuvastatin Impurity 139 Rosuvastatin Impurity 139
Rosuvastatin Impurity 124 Rosuvastatin Impurity 124
Nirmatrelvir Impurity 9 Nirmatrelvir Impurity 9
trans N-Benzyl Paroxetine trans N-Benzyl Paroxetine 105813-14-7 C26H26FNO3
Lasmiditan Impurity 10 Lasmiditan Impurity 10
Nilotinib N-Oxide Impurity 3 Nilotinib N-Oxide Impurity 3
Amoxicillin Impurity U(EP) Amoxicillin Impurity U(EP)
Pemetrexed Impurity 51 Pemetrexed Impurity 51
6-((S)-7-amino-5-azaspiro[2.4]heptan-5-yl)-8-chloro-7-fluoro-1-((1R,2S)-2-fluorocyclopropyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 6-((S)-7-amino-5-azaspiro[2.4]heptan-5-yl)-8-chloro-7-fluoro-1-((1R,2S)-2-fluorocyclopropyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
(S)-Tamsulosin Hydrochloride (S)-Tamsulosin Hydrochloride 106463-19-8 C20H28N2O5S.ClH
2,2'-Bisnalmefene 2,2'-Bisnalmefene 176220-84-1 C42H48N2O6
4-Desmethoxypropoxyl-4-chloro Rabeprazole 4-Desmethoxypropoxyl-4-chloro Rabeprazole 168167-42-8 C14H12ClN3OS
N-Desmethyl-4-hydroxy Tamoxifen (approx. 1:1 E/Z Mixture) N-Desmethyl-4-hydroxy Tamoxifen (approx. 1:1 E/Z Mixture) 110025-28-0 C25H27NO2
Rebeprazole sulfone N-oxide Rebeprazole sulfone N-oxide 924663-37-6 C18H21N3O5S
Benzeneethanamine, 4-nitro-N-(2-phenylethyl)-, hydrochloride (1:1) Benzeneethanamine, 4-nitro-N-(2-phenylethyl)-, hydrochloride (1:1) 1581285-28-0 C16H19ClN2O2
D-Glucopyranose, oligomeric, C8-10-alkyl glycosides D-Glucopyranose, oligomeric, C8-10-alkyl glycosides 161074-97-1
Odaterol Impurity 34 Odaterol Impurity 34
GLICLAZIDE IMPURITY B GLICLAZIDE IMPURITY B
Peramivir Impurity 26 Peramivir Impurity 26
Peramivir Impurity 34 Peramivir Impurity 34
(S)-2-(1-azabicyclo[2.2.2]oct-3-yl)-2,4,5,6-tetrahydro-1H-benz[de]isoquinolin-1-one hydrochloride (S)-2-(1-azabicyclo[2.2.2]oct-3-yl)-2,4,5,6-tetrahydro-1H-benz[de]isoquinolin-1-one hydrochloride
Imatinib impurity BY Imatinib impurity BY
6β-Methylprednisolone 6β-Methylprednisolone 18462-27-6 C22H30O5
DEXTROMETHORPHAN N-OXIDE DEXTROMETHORPHAN N-OXIDE 1177494-18-6 C18H25NO2
1-[(2-CHLOROPHENYL)DIPHENYLMETHYL]-1H-PYRAZOLE 1-[(2-CHLOROPHENYL)DIPHENYLMETHYL]-1H-PYRAZOLE C22H17ClN2
AMOXICILLIN TRIHYDRATE IMP. C (EP): (4S)-2-[5-(4-HYDROXYPHENYL)-3,6-DIOXOPIPERAZIN-2-YL]-5,5-DIMETHYL-THIAZOLIDINE-4-CARBOXYLIC ACID (AMOXICILLIN DIKETOPIPERAZINES) AMOXICILLIN TRIHYDRATE IMP. C (EP): (4S)-2-[5-(4-HYDROXYPHENYL)-3,6-DIOXOPIPERAZIN-2-YL]-5,5-DIMETHYL-THIAZOLIDINE-4-CARBOXYLIC ACID (AMOXICILLIN DIKETOPIPERAZINES)
Celecoxib Impurity 2 Celecoxib Impurity 2 948293-46-7 C11H9F3N2
Sugammadex sodium Impurity 45 Sugammadex sodium Impurity 45
Carboprost Trometamol 1 Carboprost Trometamol 1
Apremilast ImpurityTNN Apremilast ImpurityTNN
Tenofovir Impurity 113 Tenofovir Impurity 113 1335287-28-9 C11H13IN4O
Cefazolin USP Impurity L-δ3 Cefazolin USP Impurity L-δ3
Cabozantinib impurity 38 Cabozantinib impurity 38
Cabozantinib impurity 57 Cabozantinib impurity 57
(2R,3S)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride (2R,3S)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
(R)-2-((2R,5R)-3,6-dioxo-5-phenylpiperazin-2-yl)-5-methyl-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (R)-2-((2R,5R)-3,6-dioxo-5-phenylpiperazin-2-yl)-5-methyl-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid 860011-30-9 C16H17N3O4S
6-bromo-4-((dimethylamino)methyl)-5-hydroxy-N,1-dimethyl-2-((phenylthio)methyl)-1H-indole-3-carboxamide 6-bromo-4-((dimethylamino)methyl)-5-hydroxy-N,1-dimethyl-2-((phenylthio)methyl)-1H-indole-3-carboxamide
Dapoxetine impurity 54 Dapoxetine impurity 54
Doxofylline Impurity 21 Doxofylline Impurity 21
Dapoxetine impurity 60 Dapoxetine impurity 60
Bosutinib Impurity 37 Bosutinib Impurity 37 2095306-27-5 C39H30Cl4N6O6
ADRENOCHROME ADRENOCHROME 54-06-8 C9H9NO3
TELMISARTAN-D3 TELMISARTAN-D3 1189889-44-8 C33H27D3N4O2
1-(4-NITRO-PHENYL)-PIPERIDIN-2-ONE 1-(4-NITRO-PHENYL)-PIPERIDIN-2-ONE 39257-91-5 C5H10O2S
Atomoxetine impurity D CRS Atomoxetine impurity D CRS 873310-29-3 C17H21NO
Beraprost Impurity 2 Beraprost Impurity 2
Brivudine Impurity 2 Brivudine Impurity 2
3-METHOXYCARBONYLAMINO-4-METHYLPYRIDINE 3-METHOXYCARBONYLAMINO-4-METHYLPYRIDINE 694495-63-1 C8H10N2O2
4-chloro-6-(1-(6-ethyl-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine 4-chloro-6-(1-(6-ethyl-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine
Empagliflozin Impurity 74 Empagliflozin Impurity 74
Empagliflozin Impurity 78 Empagliflozin Impurity 78
Empagliflozin Impurity 85 Empagliflozin Impurity 85
Relugolix Impurity 11 Relugolix Impurity 11
(8S,16S,Z)-16-amino-5-(2-aminothiazol-4-yl)-11-imino-2,2-dimethyl-6,9-dioxo-8-((S)-1-(sulfoamino)ethyl)-3-oxa-4,7,10,12-tetraazaheptadec-4-ene-1,17-dioic acid (8S,16S,Z)-16-amino-5-(2-aminothiazol-4-yl)-11-imino-2,2-dimethyl-6,9-dioxo-8-((S)-1-(sulfoamino)ethyl)-3-oxa-4,7,10,12-tetraazaheptadec-4-ene-1,17-dioic acid
1-(3,4-bis(hydroxymethyl)-1H-pyrrol-2-yl)ethan-1-one 1-(3,4-bis(hydroxymethyl)-1H-pyrrol-2-yl)ethan-1-one
Gadobutrol Impurity 32 Gadobutrol Impurity 32 C14H23GdN4O6
Olmesartan Medoxomil Impurity 28 Olmesartan Medoxomil Impurity 28 1127249-17-5 C14H10Br2N4
Ornidazole Impurity 23 Ornidazole Impurity 23 1100750-18-2
Olanzapine impurity CNB Olanzapine impurity CNB
Pitavastatin Impurity 74 Pitavastatin Impurity 74 167934-30-7 C29H30FNO4
Etoricoxib Impurity 35 Etoricoxib Impurity 35 855307-79-8 C18H13ClN2O2S
Febuxostat Impurity 102 Febuxostat Impurity 102
Ticagrelor Impurity 131 Ticagrelor Impurity 131
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