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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
Cytarabine Impurity 12 Cytarabine Impurity 12 14057-18-2 C15H18N2O9
D,L-O-DesMethyl Venlafaxine-d6 D,L-O-DesMethyl Venlafaxine-d6 1062605-69-9 C16H19D6NO2
(E)-3-[p-Bromomethylphenyl]acrylic acid ethyl ester (E)-3-[p-Bromomethylphenyl]acrylic acid ethyl ester 78712-67-1 C12H13BrO2
3-Amino-2-butenoic acid 3-Amino-2-butenoic acid 21112-45-8 C4H7NO2
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionic acid methyl ester 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionic acid methyl ester 42019-07-8 C18H17ClO4
1,3-Dimethyl-5,5-diallylhexahydropyrimidine-2,4,6-trione 1,3-Dimethyl-5,5-diallylhexahydropyrimidine-2,4,6-trione 722-97-4 C12H16N2O3
DU 6858 DU 6858 127199-06-8 C19H18ClF2N3O3
rac 4-[4-(Oxiranylmethoxy)-1,2,5-thiadiazol-3-yl]morpholine rac 4-[4-(Oxiranylmethoxy)-1,2,5-thiadiazol-3-yl]morpholine 58827-68-2 C9H13N3O3S
N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester 130676-65-2 C29H53NO5
rac a-Hydroxy Ibuprofen rac a-Hydroxy Ibuprofen 60057-62-7 C13H18O3
3a,7a-dihydroxy-5-(1-methyl-1H-indole-3-carbonyl)-hexahydro-1H-benzo[d]imidazol-2(3H)-one 3a,7a-dihydroxy-5-(1-methyl-1H-indole-3-carbonyl)-hexahydro-1H-benzo[d]imidazol-2(3H)-one 171967-74-1 C17H19N3O4
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
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
(-)-menthyl benzoate (-)-menthyl benzoate 6284-35-1 C17H24O2
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
4-nitro-1H-Imidazole-2-carboxaldehyde 4-nitro-1H-Imidazole-2-carboxaldehyde 33543-81-6 C4H3N3O3
1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1133-49-9 C10H13ClO3
Bumetanide Impurity 19 Bumetanide Impurity 19
Rocuronium Bromide Impurity 26 、27 Rocuronium Bromide Impurity 26 、27
Roxadustat Impurity 20 Roxadustat Impurity 20
Ruxolitinib Impurity Ruxolitinib Impurity
	Sitagliptin Impurity 82 Sitagliptin Impurity 82
(1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate (1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate
Perospirone Impurity 21 Perospirone Impurity 21
Perospirone Impurity 11 Perospirone Impurity 11
Dolutegravir Impurity 21 Dolutegravir Impurity 21
Related impurities of fluoxetine sodium 6 Related impurities of fluoxetine sodium 6
Fondaparinux sodium impurity 7 Fondaparinux sodium impurity 7
Fondaparinux sodium impurity 3 Fondaparinux sodium impurity 3
Oxacillin sodium  Impurity B Oxacillin sodium Impurity B
Revefenacin Impurity 21 Revefenacin Impurity 21
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 C20H29ClN2O5S
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
Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]- Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]- 2749357-07-9 C12H8ClN3O2
Odaterol Impurity 36 Odaterol Impurity 36
3,3',5,5'-TETRAIODOTHYRO-ACETIC ACID 3,3',5,5'-TETRAIODOTHYRO-ACETIC ACID 67-30-1 C14H8I4O4
Avatrombopag Impurity 58 Avatrombopag Impurity 58
4-Methoxyglucobrassicin 4-Methoxyglucobrassicin 83327-21-3 C17H22N2O10S2
3-Chloro-4-morpholino-1,2,5-thiadiazole 3-Chloro-4-morpholino-1,2,5-thiadiazole 30165-96-9 C6H8ClN3OS
2,6-DIMETHYL-4-(3-NITRO-PHENYL)-PYRIDINE-3,5-DICARBOXYLIC ACID DIMETHYL ESTER 2,6-DIMETHYL-4-(3-NITRO-PHENYL)-PYRIDINE-3,5-DICARBOXYLIC ACID DIMETHYL ESTER 76258-20-3 C17H16N2O6
3-(2-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 3-(2-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 191155-81-4 C10H11F3O
monocalcium mono((3R,5S,E)-7-(4-(2-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate) monocalcium mono((3R,5S,E)-7-(4-(2-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate)
Benzenepropanoic acid, 4-(2-oxiranylmethoxy)- Benzenepropanoic acid, 4-(2-oxiranylmethoxy)- 2167848-51-1 C12H14O4
(S)-(+)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine (S)-(+)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine 132335-46-7 C19H21NOS
OEM Honey OEM Honey
D-Tryptophan, N-(trifluoroacetyl)- (9CI) D-Tryptophan, N-(trifluoroacetyl)- (9CI) 22220-03-7 C13H11F3N2O3
2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-N-(5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-1H-indazol-3-yl)benzamide 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-N-(5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-1H-indazol-3-yl)benzamide
1H-benzo[d][1,2,3]triazol-1-yl 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoate 1H-benzo[d][1,2,3]triazol-1-yl 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoate
1-Ethyl-3(3-dimethylamino)urea 1-Ethyl-3(3-dimethylamino)urea 32897-26-0 C8H19N3O
Brivaracetam Impurity 29 Brivaracetam Impurity 29
L-erythro-Hexuronic acid, 3,5-dideoxy-, 1,1-dimethylethyl ester L-erythro-Hexuronic acid, 3,5-dideoxy-, 1,1-dimethylethyl ester 1501982-84-8 C10H18O5
(Gly8-OH)-Carbetocin (Impurity B) (Gly8-OH)-Carbetocin (Impurity B)
D-Asn4-Carbetocin (Impurity F) D-Asn4-Carbetocin (Impurity F)
Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester 543699-60-1 C24H18N2O3
1,2-bis(2-methoxyphenoxy)ethane 1,2-bis(2-methoxyphenoxy)ethane 553-45-7 C16H18O4
Dispiro[11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11,2'-oxirane-3',4''-piperidine]-1''-carboxylic acid, 8-chloro-5,6-dihydro-, ethyl ester, 1-oxide Dispiro[11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11,2'-oxirane-3',4''-piperidine]-1''-carboxylic acid, 8-chloro-5,6-dihydro-, ethyl ester, 1-oxide 1432057-93-6 C22H23ClN2O4
Oseltamivir Impurity 109 Oseltamivir Impurity 109
Oseltamivir  Impurity 81 Oseltamivir Impurity 81
Oseltamivir  Impurity 71 Oseltamivir Impurity 71
1-hydrazino-3-(methylthio)propan-2-ol 1-hydrazino-3-(methylthio)propan-2-ol 14359-97-8 C4H12N2OS
Benzenemethanol, 4-(3-chloro-2-hydroxypropoxy)- Benzenemethanol, 4-(3-chloro-2-hydroxypropoxy)- 293302-44-0 C10H13ClO3
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
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 C12H14BrCl2N3O2
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
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 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
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